A Phase 2 interventional study of GSK2881078 and Matching Placebo in Cachexia, sponsored by GlaxoSmithKline. Completed at 11 sites in 3 countries. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-07-15.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
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Among 95 studies in Cachexia with a site in United States — 9 open to participants now, 11 under way, 2 of them phase 3. Cachexia · United States.
Among the 95 studies in Cachexia with a site in United States, this one is the 19th largest by enrollment of the 72 interventional ones that give a count, is the only one that started in 2018, is one of 24 in phase 2, and was the 67th registered.
331 studies on the registry are indexed under Cachexia; 74 are open to participants now.
Browse Cachexia studies →9 of the 95 studies in Cachexia with a site in United States are open now. Recruiting first, the newest first:
Bettina Mittendorfer · Sites in United States
Ages 18–100 · Healthy volunteers
CatalYm GmbH · Sites in United States, Bulgaria, Czechia and 11 more countries
Ages 18+
Pfizer · Sites in United States, Australia, Belgium and 18 more countries
Ages 18+
Endevica Bio · Sites in United States, Canada
Ages 18+
University of Kansas Medical Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 55 Cachexia studies recruiting now, 32 (58%) set no upper age limit and 14 (25%) stop at 75 or younger; 7 take children under 18; 16 take healthy volunteers.
This study: 50 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
95 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 26 · Phase 3 20 · Phase 4 2
First in 1997; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 97 is above the median of 74 across 226 interventional studies indexed under Cachexia.
Median enrollment 51 across the 72 interventional studies, 36 across the 16 observational. Of the 82 that completed or were terminated, 28 (34%) have results posted.
This tab as a report to print or save as PDF → With an account.
38 of 95 have an industry lead sponsor. The 10 most frequent:
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
GlaxoSmithKline has 5 studies filed under Cachexia — fewer than ten, so there is no comparison to draw.
4 of the studies in Cachexia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06721260University of Kansas Medical CenterMetabolism Evaluation Through Resting Indirect Calorimetry in Bladder Cancer (METRICS) | 2027-01 |
| NCT07146893University of OklahomaFeasibility Study for Repurposing RET Inhibitors | 2027-02-23 |
| NCT05705492OHSU Knight Cancer InstituteOlanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer | 2027-06-30 |
| NCT06937177Endevica BioSafely Optimizing Body Weight With Mifomelatide (TCMCB07) in Patients With Newly Diagnosed Colorectal Cancer (CRC) or Pancreatic Ductal Adenocarcinoma (PDAC) Undergoing Chemotherapy | 2027-10 |
Add all 4 to your calendar (.ics) → With an account.
Among the 95 studies in Cachexia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Impaired physical function and muscle dysfunction are a major consequence of COPD, which may be associated with increased mortality, poor quality of life and increased health care use. This is a randomized, placebo-controlled, double-blind, parallel group study to evaluate the safety and tolerability of GSK2881078, an SARM over 13 weeks of dosing in older male subjects and post-menopausal female subjects with COPD and muscle weakness. This study will also assess the effect of GSK2881078 on physical strength and function after 13 weeks of treatment. Approximately 100 subjects with COPD and muscle weakness will be randomized into two cohorts of 50 male subjects and 50 female subjects. Within each cohort, subjects will be randomized to receive GSK2881078 or placebo in a ratio of 1:1. All subjects will participate in a standardized home exercise program, which will consist of daily walking, along with several resistance or weight-bearing exercises, such as bicep curls, upright rows, step ups and a sit-to-stand maneuver. The study will consist of a screening/Baseline period of up to 30 days, a 13-week treatment period and a post-treatment follow-up period of 6 weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Male subjects between the age of 50 and 75 years will be administered GSK2881078 at a dose of 2 mg once daily by the oral route.
Drug: GSK2881078
Male subjects between the age of 50 and 75 years will be administered GSK2881078 matching placebo once daily by the oral route.
Drug: Matching Placebo
Post-menopausal female subjects between the age of 50 and 75 years will be administered GSK2881078 at a dose of 1 mg once daily by the oral route.
Drug: GSK2881078
Post-menopausal female subjects between the age of 50 and 75 years will be administered GSK2881078 matching placebo once daily by the oral route.
Drug: Matching Placebo
GSK2881078 will be available as capsules for oral administration. GSK2881078 will be administered once daily by the oral route at a dose of 1 mg and 2mg to post-menopausal female subjects and male subjects, respectively.
Subjects will be administered two capsules of GSK2881078 matching placebo once daily by the oral route.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured in a seated position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Safety Population comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
Time frame: Baseline (Day 1, Pre-dose), Days 14, 28, 56 and 90
Change From Baseline in Heart Rate
Heart rate was measured in a seated position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 14, 28, 56 and 90
Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
Twelve-lead electrocardiograms (ECG) were obtained using an automated ECG machine to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 14, 28, 56 and 90
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Blood samples were collected for the analysis of following hematology parameters: hemoglobin (Hb), lymphocyte count (Lympho), neutrophil count (Neutro) and platelet count (PC). The laboratory parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Only those participants with increase to grade 3 and increase to grade 4 are presented.
Time frame: Baseline (Day 1, Pre-dose) and up to Day 132
Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin (Bil),calcium (Ca), cholesterol (Chol), creatinine (Creat), glucose(Gl), phosphate (Phos), potassium (Pot) and sodium (Sod). The laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Values (Hyper and hypo) for Ca, Gl, Pot, Phos and Sod is presented. Only those participants with increase to grade 3 and increase to grade 4 are presented.
Time frame: Baseline (Day 1, Pre-dose) and up to Day 132
Change From Baseline in Urinalysis Parameter; Specific Gravity: Placebo-Female Participants
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 28, 56 and 90
Change From Baseline in Urinalysis Parameter; Specific Gravity: GSK2881078 1.0 mg- Female Participants
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 14 and 90
Change From Baseline in Urinalysis Parameter; Specific Gravity: Male Participants
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 28 and 90
Change From Baseline in Urinalysis Parameter; Potential of Hydrogen (pH): Placebo- Female Participants
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 28, 56 and 90
Change From Baseline in Urinalysis Parameter; pH: GSK2881078 1.0 mg- Female Participants
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 14 and 90
Change From Baseline in Urinalysis Parameter; pH: Male Participants
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 28 and 90
Number of Participants With Urinalysis Dipstick Results Post-Baseline Relative to Baseline
Urine samples were collected to analyze parameters including glucose, occult blood (OB) and protein levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as increase to trace, increase to 1+ (low concentrations present), increase to 2+ (moderate concentrations present) and increase to 3+ (high concentrations present) indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for worst-case post-Baseline relative to Baseline is presented.
Time frame: Baseline (Day 1, Pre-dose) and up to Day 132
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Number of participants who had SAEs and non-SAEs are presented.
Time frame: Up to Day 132
Percentage Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 28
Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage change from Baseline was calculated by 100\*\[(post-dose value minus Baseline value)/ Baseline value\]. Adjusted means and standard error (SE) are presented. Analysis Population comprised of the participants in the 'All Participants (all randomized participants who received at least one dose of study medication)' Population having Baseline and at least one post-Baseline assessment of the treatment the participant was randomized to.
Time frame: Baseline (Day 1, Pre-dose), Day 28
Percentage Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 56
Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage change from Baseline was calculated by 100\*\[(post-dose value minus Baseline value)/ Baseline value\]. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 56
Percentage Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 90
Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage change from Baseline was calculated by 100\*\[(post-dose value minus Baseline value)/ Baseline value\]. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 90
Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 28
Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 28
Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 56
Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 56
Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 90
Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 90
Change From Baseline in Appendicular Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 28
Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Appendicular lean mass was calculated from the regional lean mass measurements of the arms and legs using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 28
Change From Baseline in Appendicular Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 56
Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Appendicular lean mass was calculated from the regional lean mass measurements of the arms and legs using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 56
Change From Baseline in Appendicular Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 90
Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Appendicular lean mass was calculated from the regional lean mass measurements of the arms and legs using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 90
Change From Baseline in Total Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 28
Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Total lean mass was measured using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 28
Change From Baseline in Total Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 56
Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Total lean mass was measured using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 56
Change From Baseline in Total Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 90
Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Total lean mass was measured using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 90
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score at Day 28
Participants were assessed for balance, time for chair rise and gait speed. These are the three components of SPPB. Each component was scored from 0 to 4. The total SPPB score was calculated by taking sum of scores of all 3 components, which ranged from 0 (worst performance) to 12 (best performance). Higher scores indicated better performance. Scores 10 to 12 indicated 'fit/normal' and scores \<=7 indicated frail participant. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 28
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score at Day 56
Participants were assessed for balance, time for chair rise and gait speed. These are the three components of SPPB. Each component was scored from 0 to 4. The total SPPB score was calculated by taking sum of scores of all 3 components, which ranged from 0 (worst performance) to 12 (best performance). Higher scores indicated better performance. Scores 10 to 12 indicated 'fit/normal' and scores \<=7 indicated frail participant. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 56
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score at Day 90
Participants were assessed for balance, time for chair rise and gait speed. These are the three components of SPPB. Each component was scored from 0 to 4. The total SPPB score was calculated by taking sum of scores of all 3 components, which ranged from 0 (worst performance) to 12 (best performance). Higher scores indicated better performance. Scores 10 to 12 indicated 'fit/normal' and scores \<=7 indicated frail participant. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 90
Change From Baseline in 'Time for Chair Rise' as Assessed by SPPB at Day 28
'Time for chair rise' is one of the 3 components of SPPB, which was assessed by repeated chair stand test and calculated as time for five successful chair stands measured in seconds. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 28
Change From Baseline in 'Time for Chair Rise' as Assessed by SPPB at Day 56
'Time for chair rise' is one of the 3 components of SPPB, which was assessed by repeated chair stand test and calculated as time for five successful chair stands measured in seconds. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 56
Change From Baseline in 'Time for Chair Rise' as Assessed by SPPB at Day 90
'Time for chair rise' is one of the 3 components of SPPB, which was assessed by repeated chair stand test and calculated as time for five successful chair stands measured in seconds. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 90
Change From Baseline in 'Time for Fastest Walk for 4 Meter' as Assessed by SPPB at Day 28
''Time for fastest walk for 4 meter' was assessed by SPPB using 4 meter gait speed test. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 28
Change From Baseline in 'Time for Fastest Walk for 4 Meter' as Assessed by SPPB at Day 56
'Time for fastest walk for 4 meter' was assessed by SPPB using 4 meter gait speed test. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 56
Change From Baseline in 'Time for Fastest Walk for 4 Meter' as Assessed by SPPB at Day 90
'Time for fastest walk for 4 meter' was assessed by SPPB using 4 meter gait speed test. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 90
Change From Baseline in Constant Work Rate (CWR) Duration From Endurance Shuttle Walking Test
The endurance shuttle walk test is a CWR test requiring the participant to walk around a flat 10 meter track at a constant individualized pace. The test was externally paced, set to elicit a maximal exercise response (pace was based on a fixed percentage of prior incremental shuttle walk test performance, which determined a participant's peak exercise capacity). CWR duration is the time in seconds required by a participant to cover a flat 10 meter track during this test. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using analysis of covariance (ANCOVA) model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Day 90
Change From Baseline in Peak Performance From Incremental Shuttle Walking Test
An incremental shuttle walk test is an externally paced maximal exercise test which determined a participant's peak exercise capacity. The maximum duration of the test is 20 minutes. Peak performance was measured in meters, which was defined as the maximum distance covered by a participant until the participant can no longer continue walking during this test. Baseline was defined as the highest non-missing pre-dose assessment from Day -9 and Day 1. Analysis was performed using ANCOVA model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline (Highest non-missing pre-dose assessment from Day-9 and Day 1), Day 90
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Score at Day 56
The CAT is a short and simple participant-completed questionnaire which was developed for use in routine clinical practice to measure the health status of participants with COPD. The CAT is an 8-item questionnaire suitable for completion by all participants diagnosed with COPD. Participants rated their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment). A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0-40. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 56
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Score at Day 90
The CAT is a short and simple participant-completed questionnaire which was developed for use in routine clinical practice to measure the health status of participants with COPD. The CAT is an 8-item questionnaire suitable for completion by all participants diagnosed with COPD. Participants rated their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment). A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0-40. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day 1, Pre-dose), Day 90
Change From Baseline in Participant Reported Outcome (PRO)Active Individual Component: Difficulty Score at Day 56
The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains (amount and difficulty). The 'amount' domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty' domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for 'amount' and 0 to 20 for 'difficulty'. The raw scores were then transformed to a 0 to 100 Rasch analysis based scale for each domain. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented for averaged weekly difficulty score.
Time frame: Baseline (Day -9), Day 56
Change From Baseline in Participant Reported Outcome (PRO)Active Individual Component: Difficulty Score at Day 90
The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains (amount and difficulty). The 'amount' domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty' domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for 'amount' and 0 to 20 for 'difficulty'. The raw scores were then transformed to a 0 to 100 Rasch analysis based scale for each domain. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented for averaged weekly difficulty score.
Time frame: Baseline (Day -9), Day 90
Change From Baseline in Participant Reported Outcome (PRO)Active Individual Component: Amount Score at Day 56
The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains (amount and difficulty). The 'amount' domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty' domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for 'amount' and 0 to 20 for 'difficulty'. The raw scores were then transformed to a 0 to 100 Rasch analysis based scale for each domain. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented for averaged weekly amount score.
Time frame: Baseline (Day -9), Day 56
Change From Baseline in Participant Reported Outcome (PRO)Active Individual Component: Amount Score at Day 90
The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains (amount and difficulty). The 'amount' domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty' domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for 'amount' and 0 to 20 for 'difficulty'. The raw scores were then transformed to a 0 to 100 Rasch analysis based scale for each domain. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented for averaged weekly amount score.
Time frame: Baseline (Day -9), Day 90
Change From Baseline in Participant Reported Outcome (PRO)Active Total Score at Day 56
The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains(amount and difficulty). The'amount'domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty'domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for'amount'and 0 to 20 for'difficulty. The raw scores were then transformed to a 0 to 100 Rasch scale for each domain. The 'total score' was obtained by calculating the average between two domains. Total score has the range from 0 to 100. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented
Time frame: Baseline (Day -9), Day 56
Change From Baseline in Participant Reported Outcome (PRO)Active Total Score at Day 90
The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains(amount and difficulty). The'amount'domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty'domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for'amount'and 0 to 20 for'difficulty. The raw scores were then transformed to a 0 to 100 Rasch scale for each domain. The 'total score' was obtained by calculating the average between two domains. Total score has the range from 0 to 100. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time frame: Baseline (Day -9), Day 90
Change From Baseline in Steps Per Day (Physical Activity Measure) as Assessed Via an Accelerometer
Steps per day was assessed using an accelerometer, a clinically validated physical activity monitor which was used to measure the levels of physical activity. Participants wore an accelerometer for 7 days during individual timepoint. Values at Baseline, Day 56 and Day 90 were the average values collected from an accelerometer for 7 days after the Day -9, Day 56 and Day 90. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline (Day -9), Days 56 and 90
Change From Baseline in Vector Magnitude Unit Per Wear Time (Physical Activity Measure) as Assessed Via an Accelerometer
Vector magnitude unit per wear time was assessed using an accelerometer, a clinically validated physical activity monitor which was used to measure the levels of physical activity. Participants wore an accelerometer for 7 days during individual timepoint. Values at Baseline, Day 56 and Day 90 were the average values collected from accelerometer for 7 days after the Day -9, Day 56 and Day 90. Data from an accelerator was uploaded to a central site. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline (Day -9), Days 56 and 90
Number of Participants With Participant Global Impression of Change (PGIC) Score Over Time
Participant-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to assess the participant's impression of change in their disease severity since the beginning of the study. Responses to the PGIC question were on a 7 point Likert scale: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. Number of participants with PGIC score is presented by treatment group, visit and by 7 response categories.
Time frame: Days 14, 28, 56 and 90
Number of Participants With Participant Global Rating of Severity (PGRS) Score Over Time
PGRS is a single global question and was asked to participants to rate their COPD severity on a four point scale ranging from 1 to 4 (1=mild, 2=moderate, 3=severe, 4=very severe). Number of participants with PGRS score ranging from mild to very severe are presented over time.
Time frame: Days 1 and 90
Change From Baseline in St. George Respiratory Questionnaire (SGRQ) for COPD (SGRQ-c) Total Score
SGRQ-c is the COPD specific version of SGRQ. It consisted of 40 items in total, corresponding to 3 individual domains (components): symptoms, activity and impact, with different components carrying a different weighting. Component scores were calculated by summing the weights from all positive items in that component, dividing by the sum of maximum possible weights for all items in that component, and multiplying this number by 100. Total score was calculated by summing the weight to all the positive responses in each component. Total score has the range from 0 to 100. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using ANCOVA model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Day 90
Change From Baseline in SGRQ-c Symptoms Score
SGRQ-c is the COPD specific version of SGRQ. It consisted of 40 items in total, corresponding to 3 individual domains (components): symptoms, activity and impact, with different components carrying a different weighting. Component scores were calculated by summing the weights from all positive items in that component, dividing by the sum of maximum possible weights for all items in that component, and multiplying this number by 100. Symptoms component consisted of questions 1 to 7 in Part 1. Symptoms score has the range from 0 to 100. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using ANCOVA model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Day 90
Change From Baseline in SGRQ-c Activity Score
SGRQ-c is the COPD specific version of SGRQ. It consisted of 40 items in total, corresponding to 3 individual domains (components): symptoms, activity and impact, with different components carrying a different weighting. Component scores were calculated by summing the weights from all positive items in that component, dividing by the sum of maximum possible weights for all items in that component, and multiplying this number by 100. Activity component consisted of questions 9 and 12 in Part 2 of the questionnaire. Activity score has the range from 0 to 100. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using ANCOVA model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Day 90
Change From Baseline in SGRQ-c Impact Score
SGRQ-c is the COPD specific version of SGRQ. It consisted of 40 items in total, corresponding to 3 individual domains (components): symptoms, activity and impact, with different components carrying a different weighting. Component scores were calculated by summing the weights from all positive items in that component, dividing by the sum of maximum possible weights for all items in that component, and multiplying this number by 100. Impact component consisted of questions 8, 10, 11, 13, 14 in Part 2 of the questionnaire. Impact score has the range from 0 to 100. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using ANCOVA model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Day 90
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements were collected using a spirometer. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 56 and 90
Change From Baseline in Sniff Nasal Inspiratory Pressure (SnIP)
A bung size-specific to the participant was placed in the nostril deemed to be most patent by the investigator. The participant was asked to make a maximum voluntary sniff effort via a peak flow meter and the greatest effort from 10 repeat measurements were recorded. SnIP was measured in centimeter of water (cm H2O). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Days 56 and 90
Clearance (CL) of GSK2881078 Following Oral Dose in Participants
Blood samples were collected at designated timepoints. Pharmacokinetics (PK) parameters of GSK2881078 were calculated using non-compartmental methods.
Time frame: Day 14 (Pre-dose), Day 28 (Pre-dose and at 1 to 4 hours Post-dose), Day 56 (at 5 to 8 hours Post-dose), Day 90 (Pre-dose)
Volume of Distribution at Steady State (Vss) of GSK2881078 Following Oral Dose in Participants
Blood samples were collected at designated timepoints. PK parameters of GSK2881078 were calculated using non-compartmental methods.
Time frame: Day 14 (Pre-dose), Day 28 (Pre-dose and at 1 to 4 hours Post-dose), Day 56 (at 5 to 8 hours Post-dose), Day 90 (Pre-dose)
This was a Phase II, double-blind, randomized, multicenter study to evaluate the safety and efficacy of GSK2881078 over 13 weeks of once daily oral dosing, first time administered in older men and post-menopausal female participants with chronic obstructive pulmonary disease (COPD) and muscle weakness, participating in home exercise.
| Milestone | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Started | 23 | 24 | 24 | 25 |
| Completed | 21 | 18 | 18 | 20 |
| Not completed | 2 | 6 | 6 | 5 |
| Withdrew: Adverse event | 0 | 2 | 5 | 3 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 0 |
| Withdrew: Physician decision | 0 | 1 | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 2 | 1 | 0 |
| Withdrew: Protocol-defined stopping criteria | 1 | 0 | 0 | 1 |
SBP and DBP were measured in a seated position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Safety Population comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
| Millimeters of mercury | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| SBP,Day 14,n=22,23,23,24 | 3.0 ± 19.63 | 2.1 ± 11.03 | -2.1 ± 9.33 | 3.1 ± 11.65 |
| SBP,Day 28,n=22,20,23,24 | 3.7 ± 12.76 | -0.1 ± 12.82 | 2.6 ± 14.39 | 5.8 ± 9.49 |
| SBP,Day 56,n=21,19,20,21 | 3.3 ± 14.96 | 7.8 ± 16.38 | -2.4 ± 17.68 | 1.3 ± 9.12 |
| SBP,Day 90,n=21,18,18,20 | 1.0 ± 14.23 | 7.6 ± 15.56 | -4.2 ± 18.52 | 5.8 ± 18.61 |
| DBP,Day 14,n=22,23,23,24 | 1.9 ± 6.88 | 1.1 ± 6.93 | -3.4 ± 6.20 | -0.4 ± 7.47 |
| DBP,Day 28,n=22,20,23,24 | 3.6 ± 7.08 | 1.4 ± 7.58 | 0.7 ± 7.90 | 1.0 ± 5.36 |
| DBP,Day 56,n=21,19,20,21 | 2.1 ± 7.00 | 2.9 ± 6.07 | -2.5 ± 10.38 | -1.6 ± 8.16 |
| DBP,Day 90,n=21,18,18,20 | -1.0 ± 6.47 | 2.9 ± 8.37 | -0.1 ± 12.98 | 0.6 ± 6.95 |
Heart rate was measured in a seated position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| Beats per minute | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Day 14,n=22,23,23,24 | -0.7 ± 9.79 | 3.3 ± 9.16 | 1.7 ± 10.61 | -0.4 ± 6.60 |
| Day 28,n=22,20,23,24 | 2.2 ± 8.11 | 2.1 ± 9.64 | 4.6 ± 10.71 | -1.7 ± 10.71 |
| Day 56,n=21,19,20,21 | 0.2 ± 8.87 | -1.0 ± 8.81 | 2.8 ± 7.17 | 0.2 ± 6.36 |
| Day 90,n=21,18,18,20 | 1.1 ± 7.99 | 2.3 ± 10.34 | 7.4 ± 10.23 | -0.6 ± 8.17 |
Twelve-lead electrocardiograms (ECG) were obtained using an automated ECG machine to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| Milliseconds | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| PR interval,Day 14,n=22,23,22,24 | -1.303 ± 9.9261 | -0.377 ± 7.2588 | -2.455 ± 12.6556 | -2.875 ± 24.3370 |
| PR interval,,Day 28,n=22,20,22,24 | -0.061 ± 7.9340 | -4.717 ± 19.3177 | -2.333 ± 17.5966 | 4.139 ± 15.5796 |
| PR interval,,Day 56,n=21,19,20,21 | 1.302 ± 12.1220 | 0.596 ± 6.5250 | 0.483 ± 7.5436 | 10.444 ± 27.5133 |
| PR interval,,Day 90,n=21,18,17,20 | -0.270 ± 9.3111 | -6.167 ± 28.9117 | -3.373 ± 9.6845 | 3.033 ± 20.7947 |
| QRS Duration,Day 14,n=22,23,23,24 | 4.364 ± 22.8107 | 1.362 ± 10.4736 | -0.464 ± 7.4791 | 1.167 ± 4.1772 |
| QRS Duration,Day 28,n=22,20,23,24 | 1.000 ± 7.7014 | 6.200 ± 28.2707 | -1.478 ± 5.5047 | -0.542 ± 3.3547 |
| QRS Duration,Day 56,n=21,19,20,21 | -0.095 ± 5.9639 | 1.842 ± 5.4096 | -1.100 ± 4.9631 | -0.413 ± 4.6271 |
| QRS Duration,Day 90,n=21,18,18,20 | -2.397 ± 14.1494 | -2.444 ± 4.5360 | 1.333 ± 25.4163 | 1.333 ± 6.3005 |
| QT Interval,Day 14,n=22,23,23,24 | 0.576 ± 19.8239 | -14.290 ± 17.7216 | -0.638 ± 22.5431 | -0.597 ± 15.5697 |
| QT Interval,Day 28,n=22,20,23,24 | -1.333 ± 23.5300 | -16.133 ± 26.2775 | -4.203 ± 23.3733 | -1.750 ± 22.6539 |
| QT Interval,Day 56,n=21,19,20,21 | -0.127 ± 13.5567 | -13.947 ± 18.3657 | -1.533 ± 20.5897 | -1.857 ± 14.6881 |
| QT Interval,Day 90,n=21,18,18,20 | 4.063 ± 16.9160 | -16.352 ± 20.7511 | -4.574 ± 17.1825 | -5.167 ± 17.7759 |
| QTcF Interval,Day 14,n=21,21,21,21 | 1.749 ± 11.7762 | -7.143 ± 9.2710 | -1.235 ± 11.3507 | -2.698 ± 9.7085 |
| QTcF Interval,Day 28,n=21,19,21,21 | 0.362 ± 15.7742 | -12.930 ± 11.7707 | -0.489 ± 10.5492 | -4.340 ± 12.8445 |
| QTcF Interval,Day 56,n=20,18,18,18 | 1.333 ± 8.5039 | -12.222 ± 10.2975 | 1.093 ± 10.0462 | -3.357 ± 10.5127 |
| QTcF Interval,Day 90,n=20,17,18,17 | 3.600 ± 10.3526 | -12.627 ± 11.5776 | 2.657 ± 12.2002 | -11.804 ± 11.7207 |
| QTcB Interval,Day 14,n=4,5,4,7 | -4.333 ± 26.2100 | 2.193 ± 12.5624 | 12.917 ± 13.6582 | 0.571 ± 11.0180 |
| QTcB Interval,Day 28,n=4,3,4,7 | -1.167 ± 12.1549 | 13.667 ± 24.7678 | -7.667 ± 8.8192 | -10.238 ± 11.6678 |
| QTcB Interval,Day 56,n=3,3,4,6 | -13.556 ± 11.3741 | -7.667 ± 9.7125 | 13.417 ± 8.0017 | -9.500 ± 7.2411 |
| QTcB Interval,Day 90,n=3,3,2,6 | 1.333 ± 15.9199 | -13.111 ± 3.0972 | 32.000 ± 1.4142 | -10.278 ± 9.6088 |
Blood samples were collected for the analysis of following hematology parameters: hemoglobin (Hb), lymphocyte count (Lympho), neutrophil count (Neutro) and platelet count (PC). The laboratory parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Only those participants with increase to grade 3 and increase to grade 4 are presented.
| Participants | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Hb, Anemia, increase to Grade 3 | 0 | 0 | 0 | 0 |
| Hb, Anemia, increase to Grade 4 | 0 | 0 | 0 | 0 |
| Hb, Hb increased, increase to Grade 3 | 0 | 0 | 0 | 0 |
| Hb, Hb increased, increase to Grade 4 | 0 | 0 | 0 | 0 |
| Lympho, Lymph count decreased, increase to Grade 3 | 0 | 0 | 0 | 0 |
| Lympho, Lymph count decreased, increase to Grade 4 | 0 | 0 | 0 | 0 |
| Lympho, Lymph count increased, increase to Grade 3 | 0 | 0 | 0 | 0 |
| Lympho, Lymph count increased, increase to Grade 4 | 0 | 0 | 0 | 0 |
| Neutro,Neutro count decreased,increase to Grade 3 | 0 | 0 | 0 | 0 |
| Neutro,Neutro count decreased,increase to Grade 4 | 0 | 0 | 0 | 0 |
| PC, PC decreased,increase to Grade 3 | 0 | 0 | 0 | 0 |
| PC, PC decreased,increase to Grade 4 | 0 | 0 | 0 | 0 |
| PC, PC increased,increase to Grade 3 | 0 | 0 | 0 | 0 |
| PC, PC increased,increase to Grade 4 | 0 | 0 | 0 | 0 |
Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin (Bil),calcium (Ca), cholesterol (Chol), creatinine (Creat), glucose(Gl), phosphate (Phos), potassium (Pot) and sodium (Sod). The laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Values (Hyper and hypo) for Ca, Gl, Pot, Phos and Sod is presented. Only those participants with increase to grade 3 and increase to grade 4 are presented.
| Participants | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| ALT, ALT increased, increase to Grade 3 | 0 | 1 | 0 | 1 |
| ALT, ALT increased, increase to Grade 4 | 0 | 0 | 0 | 0 |
| ALP, ALP increased, increase to Grade 3 | 0 | 0 | 0 | 0 |
| ALP, ALP increased, increase to Grade 4 | 0 | 0 | 0 | 0 |
| AST, AST increased, increase to Grade 3 | 0 | 0 | 0 | 0 |
| AST, AST increased, increase to Grade 4 | 0 | 0 | 0 | 0 |
| Bil, Blood Bil increased, increase to Grade 3 | 0 | 0 | 0 | 0 |
| Bil, Blood Bil increased, increase to Grade 4 | 0 | 0 | 0 | 0 |
| Ca, Hyper,increase to Grade 3 | 0 | 0 | 0 | 0 |
| Ca, Hyper,increase to Grade 4 | 0 | 0 | 0 | 0 |
| Ca, Hypo,increase to Grade 3 | 0 | 0 | 0 | 0 |
| Ca, Hypo,increase to Grade 4 | 0 | 0 | 0 | 0 |
| Chol, Chol high,increase to Grade 3 | 0 | 0 | 0 | 0 |
| Chol, Chol high,increase to Grade 4 | 0 | 0 | 0 | 0 |
| Creat, Creat increased,increase to Grade 3 | 0 | 0 | 0 | 0 |
| Creat, Creat increased,increase to Grade 4 | 0 | 0 | 0 | 0 |
| Gl, Hyper,increase to Grade 3 | 0 | 0 | 0 | 1 |
| Gl, Hyper,increase to Grade 4 | 0 | 0 | 0 | 0 |
| Gl, Hypo,increase to Grade 3 | 0 | 0 | 0 | 0 |
| Gl, Hypo,increase to Grade 4 | 0 | 0 | 0 | 0 |
| Phos, Hyper,increase to Grade 3 | 0 | 0 | 0 | 0 |
| Phos, Hyper,increase to Grade 4 | 0 | 0 | 0 | 0 |
| Phos, Hypo,increase to Grade 3 | 0 | 0 | 0 | 0 |
| Phos, Hypo,increase to Grade 4 | 0 | 0 | 0 | 0 |
| Pot, Hyper,increase to Grade 3 | 0 | 0 | 0 | 0 |
| Pot, Hyper,increase to Grade 4 | 0 | 0 | 0 | 0 |
| Pot, Hypo,increase to Grade 3 | 0 | 0 | 1 | 0 |
| Pot, Hypo,increase to Grade 4 | 0 | 0 | 0 | 0 |
| Sod, Hyper,increase to Grade 3 | 0 | 0 | 0 | 0 |
| Sod, Hyper,increase to Grade 4 | 0 | 0 | 0 | 0 |
| Sod, Hypo,increase to Grade 3 | 2 | 0 | 0 | 0 |
| Sod, Hypo,increase to Grade 4 | 0 | 0 | 0 | 0 |
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| Ratio | Placebo- Female Participants |
|---|---|
| Day 28,n=1 | 0.0030 ± NA |
| Day 56,n=1 | 0.0020 ± NA |
| Day 90,n=21 | -0.0006 ± 0.00612 |
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| Ratio | GSK2881078 1.0 mg- Female Participants |
|---|---|
| Day 14,n=1 | 0.000 ± NA |
| Day 90,n=18 | 0.0049 ± 0.00711 |
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| Ratio | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|
| Day 28,n=1,1 | -0.0080 ± NA | 0.0040 ± NA |
| Day 90,n=19,20 | 0.0017 ± 0.00870 | 0.0018 ± 0.00610 |
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| pH | Placebo- Female Participants |
|---|---|
| Day 28,n=1 | 0.0000 ± NA |
| Day 56,n=1 | -0.5000 ± NA |
| Day 90,n=21 | 0.0000 ± 0.80623 |
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| pH | GSK2881078 1.0 mg- Female Participants |
|---|---|
| Day 14,n=1 | 1.0000 ± NA |
| Day 90,n=18 | -0.1111 ± 0.60768 |
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| pH | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|
| Day 28,n=1,1 | 1.0000 ± NA | 0.5000 ± NA |
| Day 90,n=19,20 | -0.1579 ± 0.72749 | 0.3000 ± 0.71451 |
Urine samples were collected to analyze parameters including glucose, occult blood (OB) and protein levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as increase to trace, increase to 1+ (low concentrations present), increase to 2+ (moderate concentrations present) and increase to 3+ (high concentrations present) indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for worst-case post-Baseline relative to Baseline is presented.
| Participants | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Glucose: increase to trace | 0 | 0 | 1 | 0 |
| Glucose: increase to 1+ | 0 | 0 | 0 | 0 |
| Glucose: increase to 2+ | 0 | 0 | 0 | 0 |
| Glucose: increase to 3+ | 0 | 0 | 0 | 1 |
| OB: increase to trace | 1 | 0 | 1 | 1 |
| OB: increase to 1+ | 1 | 1 | 1 | 0 |
| OB: increase to 2+ | 1 | 2 | 0 | 0 |
| OB: increase to 3+ | 0 | 0 | 0 | 1 |
| Protein: increase to trace | 2 | 2 | 3 | 6 |
| Protein: increase to 1+ | 0 | 3 | 1 | 3 |
| Protein: increase to 2+ | 0 | 1 | 0 | 1 |
| Protein: increase to 3+ | 0 | 0 | 0 | 0 |
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Number of participants who had SAEs and non-SAEs are presented.
| Participants | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Non-SAEs | 15 | 18 | 13 | 17 |
| SAEs | 1 | 2 | 2 | 0 |
Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage change from Baseline was calculated by 100\*\[(post-dose value minus Baseline value)/ Baseline value\]. Adjusted means and standard error (SE) are presented. Analysis Population comprised of the participants in the 'All Participants (all randomized participants who received at least one dose of study medication)' Population having Baseline and at least one post-Baseline assessment of the treatment the participant was randomized to.
| Percentage change | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Percentage Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 28 | 4.82 ± 2.406 | 9.34 ± 2.459 | 1.55 ± 2.940 | 9.35 ± 2.848 |
Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage change from Baseline was calculated by 100\*\[(post-dose value minus Baseline value)/ Baseline value\]. Adjusted means and SE are presented.
| Percentage change | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Percentage Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 56 | 0.08 ± 2.787 | 16.78 ± 2.925 | 5.73 ± 3.921 | 11.07 ± 3.922 |
Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage change from Baseline was calculated by 100\*\[(post-dose value minus Baseline value)/ Baseline value\]. Adjusted means and SE are presented.
| Percentage change | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Percentage Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 90 | 12.76 ± 4.061 | 17.93 ± 4.179 | 7.15 ± 2.759 | 14.17 ± 2.632 |
Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Kilograms | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 28 | 4.2 ± 3.01 | 10.0 ± 3.08 | 3.0 ± 5.06 | 16.5 ± 4.90 |
Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Kilograms | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 56 | 0.6 ± 4.29 | 21.3 ± 4.50 | 8.3 ± 7.69 | 15.7 ± 7.69 |
Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Kilograms | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 90 | 12.3 ± 4.31 | 20.3 ± 4.45 | 14.2 ± 5.17 | 26.0 ± 4.91 |
Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Appendicular lean mass was calculated from the regional lean mass measurements of the arms and legs using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Kilograms | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Appendicular Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 28 | -0.240 ± 0.0974 | 0.642 ± 0.1023 | 0.055 ± 0.1920 | 0.346 ± 0.1831 |
Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Appendicular lean mass was calculated from the regional lean mass measurements of the arms and legs using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Kilograms | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Appendicular Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 56 | -0.134 ± 0.1410 | 0.848 ± 0.1540 | -0.464 ± 0.1887 | 0.663 ± 0.1829 |
Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Appendicular lean mass was calculated from the regional lean mass measurements of the arms and legs using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Kilograms | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Appendicular Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 90 | -0.434 ± 0.1657 | 0.946 ± 0.1818 | -0.225 ± 0.2306 | 0.899 ± 0.2117 |
Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Total lean mass was measured using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Kilograms | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Total Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 28 | -0.017 ± 0.2004 | 1.150 ± 0.2106 | 0.075 ± 0.3004 | 0.998 ± 0.2869 |
Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Total lean mass was measured using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Kilograms | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Total Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 56 | -0.564 ± 0.2372 | 1.522 ± 0.2587 | -0.373 ± 0.3820 | 1.327 ± 0.3700 |
Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Total lean mass was measured using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Kilograms | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Total Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 90 | -0.531 ± 0.3349 | 1.577 ± 0.3666 | -0.424 ± 0.5056 | 1.689 ± 0.4666 |
Participants were assessed for balance, time for chair rise and gait speed. These are the three components of SPPB. Each component was scored from 0 to 4. The total SPPB score was calculated by taking sum of scores of all 3 components, which ranged from 0 (worst performance) to 12 (best performance). Higher scores indicated better performance. Scores 10 to 12 indicated 'fit/normal' and scores \<=7 indicated frail participant. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Scores on a scale | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Total Short Physical Performance Battery (SPPB) Score at Day 28 | 0.3 ± 0.25 | 0.4 ± 0.26 | 0.2 ± 0.19 | 0.3 ± 0.18 |
Participants were assessed for balance, time for chair rise and gait speed. These are the three components of SPPB. Each component was scored from 0 to 4. The total SPPB score was calculated by taking sum of scores of all 3 components, which ranged from 0 (worst performance) to 12 (best performance). Higher scores indicated better performance. Scores 10 to 12 indicated 'fit/normal' and scores \<=7 indicated frail participant. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Scores on a scale | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Total Short Physical Performance Battery (SPPB) Score at Day 56 | 0.4 ± 0.24 | 0.4 ± 0.25 | 0.1 ± 0.24 | 0.4 ± 0.24 |
Participants were assessed for balance, time for chair rise and gait speed. These are the three components of SPPB. Each component was scored from 0 to 4. The total SPPB score was calculated by taking sum of scores of all 3 components, which ranged from 0 (worst performance) to 12 (best performance). Higher scores indicated better performance. Scores 10 to 12 indicated 'fit/normal' and scores \<=7 indicated frail participant. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Scores on a scale | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Total Short Physical Performance Battery (SPPB) Score at Day 90 | 0.3 ± 0.26 | 0.5 ± 0.28 | 0.4 ± 0.23 | 0.5 ± 0.22 |
'Time for chair rise' is one of the 3 components of SPPB, which was assessed by repeated chair stand test and calculated as time for five successful chair stands measured in seconds. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Seconds | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in 'Time for Chair Rise' as Assessed by SPPB at Day 28 | -0.644 ± 0.6333 | -1.196 ± 0.6491 | -0.464 ± 0.3841 | -0.537 ± 0.3763 |
'Time for chair rise' is one of the 3 components of SPPB, which was assessed by repeated chair stand test and calculated as time for five successful chair stands measured in seconds. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Seconds | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in 'Time for Chair Rise' as Assessed by SPPB at Day 56 | -1.207 ± 0.5912 | -2.023 ± 0.6124 | -0.323 ± 0.5294 | -0.160 ± 0.5282 |
'Time for chair rise' is one of the 3 components of SPPB, which was assessed by repeated chair stand test and calculated as time for five successful chair stands measured in seconds. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Seconds | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in 'Time for Chair Rise' as Assessed by SPPB at Day 90 | -1.070 ± 0.6956 | -2.030 ± 0.7362 | 1.144 ± 1.4013 | -0.793 ± 1.3401 |
''Time for fastest walk for 4 meter' was assessed by SPPB using 4 meter gait speed test. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Seconds | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in 'Time for Fastest Walk for 4 Meter' as Assessed by SPPB at Day 28 | -0.236 ± 0.1132 | -0.277 ± 0.1161 | -0.167 ± 0.1133 | -0.110 ± 0.1108 |
'Time for fastest walk for 4 meter' was assessed by SPPB using 4 meter gait speed test. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Seconds | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in 'Time for Fastest Walk for 4 Meter' as Assessed by SPPB at Day 56 | 0.010 ± 0.1487 | -0.276 ± 0.1560 | -0.093 ± 0.1437 | -0.284 ± 0.1438 |
'Time for fastest walk for 4 meter' was assessed by SPPB using 4 meter gait speed test. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Seconds | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in 'Time for Fastest Walk for 4 Meter' as Assessed by SPPB at Day 90 | -0.043 ± 0.2194 | -0.055 ± 0.2361 | -0.130 ± 0.1331 | -0.360 ± 0.1275 |
The endurance shuttle walk test is a CWR test requiring the participant to walk around a flat 10 meter track at a constant individualized pace. The test was externally paced, set to elicit a maximal exercise response (pace was based on a fixed percentage of prior incremental shuttle walk test performance, which determined a participant's peak exercise capacity). CWR duration is the time in seconds required by a participant to cover a flat 10 meter track during this test. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using analysis of covariance (ANCOVA) model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| Seconds | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Constant Work Rate (CWR) Duration From Endurance Shuttle Walking Test | -6.5 ± 26.78 | 4.6 ± 29.25 | 105.1 ± 54.94 | -44.2 ± 51.97 |
An incremental shuttle walk test is an externally paced maximal exercise test which determined a participant's peak exercise capacity. The maximum duration of the test is 20 minutes. Peak performance was measured in meters, which was defined as the maximum distance covered by a participant until the participant can no longer continue walking during this test. Baseline was defined as the highest non-missing pre-dose assessment from Day -9 and Day 1. Analysis was performed using ANCOVA model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| Meters | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Peak Performance From Incremental Shuttle Walking Test | -10.5 ± 14.76 | -17.2 ± 15.16 | -7.5 ± 15.84 | -42.3 ± 15.02 |
The CAT is a short and simple participant-completed questionnaire which was developed for use in routine clinical practice to measure the health status of participants with COPD. The CAT is an 8-item questionnaire suitable for completion by all participants diagnosed with COPD. Participants rated their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment). A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0-40. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Scores on a Scale | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Score at Day 56 | -0.8 ± 0.92 | -1.2 ± 0.97 | -0.4 ± 1.14 | -1.0 ± 1.14 |
The CAT is a short and simple participant-completed questionnaire which was developed for use in routine clinical practice to measure the health status of participants with COPD. The CAT is an 8-item questionnaire suitable for completion by all participants diagnosed with COPD. Participants rated their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment). A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0-40. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Scores on a Scale | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Score at Day 90 | -1.3 ± 0.79 | -2.2 ± 0.85 | -1.4 ± 0.94 | 0.8 ± 0.90 |
The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains (amount and difficulty). The 'amount' domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty' domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for 'amount' and 0 to 20 for 'difficulty'. The raw scores were then transformed to a 0 to 100 Rasch analysis based scale for each domain. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented for averaged weekly difficulty score.
| Scores on a Scale | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Participant Reported Outcome (PRO)Active Individual Component: Difficulty Score at Day 56 | 3.7 ± 1.59 | -1.1 ± 1.80 | 1.3 ± 2.16 | -0.8 ± 2.08 |
The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains (amount and difficulty). The 'amount' domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty' domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for 'amount' and 0 to 20 for 'difficulty'. The raw scores were then transformed to a 0 to 100 Rasch analysis based scale for each domain. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented for averaged weekly difficulty score.
| Scores on a Scale | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Participant Reported Outcome (PRO)Active Individual Component: Difficulty Score at Day 90 | 2.0 ± 1.90 | -2.9 ± 1.84 | 2.8 ± 2.56 | -1.2 ± 2.65 |
The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains (amount and difficulty). The 'amount' domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty' domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for 'amount' and 0 to 20 for 'difficulty'. The raw scores were then transformed to a 0 to 100 Rasch analysis based scale for each domain. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented for averaged weekly amount score.
| Scores on a Scale | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Participant Reported Outcome (PRO)Active Individual Component: Amount Score at Day 56 | 3.3 ± 1.09 | 0.2 ± 1.24 | 2.5 ± 1.83 | 2.3 ± 1.77 |
The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains (amount and difficulty). The 'amount' domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty' domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for 'amount' and 0 to 20 for 'difficulty'. The raw scores were then transformed to a 0 to 100 Rasch analysis based scale for each domain. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented for averaged weekly amount score.
| Scores on a Scale | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Participant Reported Outcome (PRO)Active Individual Component: Amount Score at Day 90 | -0.2 ± 2.05 | 3.8 ± 1.98 | -0.8 ± 2.33 | 2.7 ± 2.47 |
The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains(amount and difficulty). The'amount'domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty'domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for'amount'and 0 to 20 for'difficulty. The raw scores were then transformed to a 0 to 100 Rasch scale for each domain. The 'total score' was obtained by calculating the average between two domains. Total score has the range from 0 to 100. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented
| Scores on a Scale | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Participant Reported Outcome (PRO)Active Total Score at Day 56 | 3.7 ± 0.89 | -0.5 ± 1.03 | 2.1 ± 1.09 | 0.5 ± 1.05 |
The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains(amount and difficulty). The'amount'domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty'domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for'amount'and 0 to 20 for'difficulty. The raw scores were then transformed to a 0 to 100 Rasch scale for each domain. The 'total score' was obtained by calculating the average between two domains. Total score has the range from 0 to 100. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
| Scores on a Scale | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in Participant Reported Outcome (PRO)Active Total Score at Day 90 | 1.3 ± 1.20 | 0.3 ± 1.14 | 1.2 ± 1.57 | 0.5 ± 1.66 |
Steps per day was assessed using an accelerometer, a clinically validated physical activity monitor which was used to measure the levels of physical activity. Participants wore an accelerometer for 7 days during individual timepoint. Values at Baseline, Day 56 and Day 90 were the average values collected from an accelerometer for 7 days after the Day -9, Day 56 and Day 90. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| Steps per day | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Day 56,n=17,14,14,17 | 285.19 ± 1289.604 | 389.58 ± 1322.701 | 120.41 ± 1282.092 | -17.40 ± 1334.539 |
| Day 90,n=17,17,14,14 | -246.45 ± 756.414 | 786.21 ± 1439.988 | -527.07 ± 1077.747 | 611.36 ± 1499.559 |
Vector magnitude unit per wear time was assessed using an accelerometer, a clinically validated physical activity monitor which was used to measure the levels of physical activity. Participants wore an accelerometer for 7 days during individual timepoint. Values at Baseline, Day 56 and Day 90 were the average values collected from accelerometer for 7 days after the Day -9, Day 56 and Day 90. Data from an accelerator was uploaded to a central site. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| Vector magnitude units per minute | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Day 56,n=17,14,14,17 | 9.19 ± 82.596 | -4.83 ± 66.400 | 56.42 ± 86.284 | 71.98 ± 175.403 |
| Day 90,n=17,17,14,14 | -6.60 ± 65.648 | 0.40 ± 64.670 | -3.73 ± 74.849 | 42.36 ± 184.191 |
Participant-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to assess the participant's impression of change in their disease severity since the beginning of the study. Responses to the PGIC question were on a 7 point Likert scale: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. Number of participants with PGIC score is presented by treatment group, visit and by 7 response categories.
| Participants | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Day 14, much worse,n=21,20,23,23 | 0 | 0 | 0 | 0 |
| Day 14, worse,n=21,20,23,23 | 0 | 0 | 0 | 1 |
| Day 14, slightly worse,n=21,20,23,23 | 0 | 1 | 0 | 0 |
| Day 14, no change,n=21,20,23,23 | 6 | 5 | 9 | 9 |
| Day 14, slightly better,n=21,20,23,23 | 7 | 7 | 4 | 4 |
| Day 14, better,n=21,20,23,23 | 7 | 5 | 8 | 7 |
| Day 14, much better,n=21,20,23,23 | 1 | 2 | 2 | 2 |
| Day 28, much worse,n=21,20,21,22 | 0 | 0 | 0 | 0 |
| Day 28, worse,n=21,20,21,22 | 0 | 0 | 0 | 0 |
| Day 28, slightly worse,n=21,20,21,22 | 1 | 2 | 0 | 0 |
| Day 28, no change,n=21,20,21,22 | 3 | 6 | 4 | 6 |
| Day 28, slightly better,n=21,20,21,22 | 9 | 6 | 10 | 7 |
| Day 28, better,n=21,20,21,22 | 5 | 6 | 5 | 7 |
| Day 28, much better,n=21,20,21,22 | 3 | 0 | 2 | 2 |
| Day 56, much worse,n=21,19,21,21 | 0 | 0 | 0 | 0 |
| Day 56, worse,n=21,19,21,21 | 0 | 0 | 0 | 0 |
| Day 56, slightly worse,n=21,19,21,21 | 1 | 3 | 1 | 4 |
| Day 56, no change,n=21,19,21,21 | 2 | 5 | 4 | 5 |
| Day 56, slightly better,n=21,19,21,21 | 6 | 4 | 7 | 5 |
| Day 56, better,n=21,19,21,21 | 10 | 6 | 8 | 5 |
| Day 56, much better,n=21,19,21,21 | 2 | 1 | 1 | 2 |
| Day 90, much worse,n=21,18,18,20 | 0 | 0 | 0 | 0 |
| Day 90, worse,n=21,18,18,20 | 0 | 1 | 0 | 0 |
| Day 90, slightly worse,n=21,18,18,20 | 1 | 0 | 0 | 0 |
| Day 90, no change,n=21,18,18,20 | 9 | 8 | 5 | 6 |
| Day 90, slightly better,n=21,18,18,20 | 7 | 3 | 9 | 9 |
| Day 90, better,n=21,18,18,20 | 3 | 4 | 4 | 4 |
| Day 90, much better,n=21,18,18,20 | 1 | 2 | 0 | 1 |
PGRS is a single global question and was asked to participants to rate their COPD severity on a four point scale ranging from 1 to 4 (1=mild, 2=moderate, 3=severe, 4=very severe). Number of participants with PGRS score ranging from mild to very severe are presented over time.
| Participants | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Day 1, mild,n=21,20,23,23 | 2 | 0 | 0 | 2 |
| Day 1, moderate,n=21,20,23,23 | 9 | 13 | 11 | 12 |
| Day 1, severe,n=21,20,23,23 | 8 | 7 | 12 | 8 |
| Day 1, very severe,n=21,20,23,23 | 2 | 0 | 0 | 1 |
| Day 90, mild,n=21,18,18,20 | 4 | 4 | 1 | 5 |
| Day 90, moderate,n=21,18,18,20 | 9 | 7 | 9 | 2 |
| Day 90, severe,n=21,18,18,20 | 6 | 6 | 8 | 12 |
| Day 90, very severe,n=21,18,18,20 | 2 | 1 | 0 | 1 |
SGRQ-c is the COPD specific version of SGRQ. It consisted of 40 items in total, corresponding to 3 individual domains (components): symptoms, activity and impact, with different components carrying a different weighting. Component scores were calculated by summing the weights from all positive items in that component, dividing by the sum of maximum possible weights for all items in that component, and multiplying this number by 100. Total score was calculated by summing the weight to all the positive responses in each component. Total score has the range from 0 to 100. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using ANCOVA model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| Scores on a scale | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in St. George Respiratory Questionnaire (SGRQ) for COPD (SGRQ-c) Total Score | -3.9 ± 1.71 | -0.9 ± 1.90 | -1.7 ± 1.87 | 0.4 ± 1.77 |
SGRQ-c is the COPD specific version of SGRQ. It consisted of 40 items in total, corresponding to 3 individual domains (components): symptoms, activity and impact, with different components carrying a different weighting. Component scores were calculated by summing the weights from all positive items in that component, dividing by the sum of maximum possible weights for all items in that component, and multiplying this number by 100. Symptoms component consisted of questions 1 to 7 in Part 1. Symptoms score has the range from 0 to 100. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using ANCOVA model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| Scores on a scale | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in SGRQ-c Symptoms Score | -4.0 ± 2.95 | -1.4 ± 3.29 | -3.5 ± 3.38 | -4.0 ± 3.20 |
SGRQ-c is the COPD specific version of SGRQ. It consisted of 40 items in total, corresponding to 3 individual domains (components): symptoms, activity and impact, with different components carrying a different weighting. Component scores were calculated by summing the weights from all positive items in that component, dividing by the sum of maximum possible weights for all items in that component, and multiplying this number by 100. Activity component consisted of questions 9 and 12 in Part 2 of the questionnaire. Activity score has the range from 0 to 100. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using ANCOVA model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| Scores on a scale | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in SGRQ-c Activity Score | -5.4 ± 2.00 | -3.4 ± 2.23 | 1.2 ± 2.57 | 1.6 ± 2.44 |
SGRQ-c is the COPD specific version of SGRQ. It consisted of 40 items in total, corresponding to 3 individual domains (components): symptoms, activity and impact, with different components carrying a different weighting. Component scores were calculated by summing the weights from all positive items in that component, dividing by the sum of maximum possible weights for all items in that component, and multiplying this number by 100. Impact component consisted of questions 8, 10, 11, 13, 14 in Part 2 of the questionnaire. Impact score has the range from 0 to 100. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using ANCOVA model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| Scores on a scale | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Change From Baseline in SGRQ-c Impact Score | -2.8 ± 2.03 | 0.6 ± 2.25 | -2.7 ± 1.76 | 0.8 ± 1.67 |
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements were collected using a spirometer. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| Liters | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Day 56,n=21,19,21,21 | -0.000 ± 0.0918 | -0.028 ± 0.0747 | 0.012 ± 0.1342 | -0.016 ± 0.2377 |
| Day 90,n=20,18,18,20 | 0.002 ± 0.0970 | -0.024 ± 0.0833 | 0.050 ± 0.1130 | 0.007 ± 0.2208 |
A bung size-specific to the participant was placed in the nostril deemed to be most patent by the investigator. The participant was asked to make a maximum voluntary sniff effort via a peak flow meter and the greatest effort from 10 repeat measurements were recorded. SnIP was measured in centimeter of water (cm H2O). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
| centimeter of water | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Day 56,n=21,19,21,21 | -6.0 ± 11.20 | 3.4 ± 14.14 | 0.7 ± 17.82 | -0.8 ± 15.51 |
| Day 90,n=20,18,18,20 | -0.7 ± 8.55 | -0.4 ± 11.34 | -1.2 ± 15.21 | 2.5 ± 21.39 |
Blood samples were collected at designated timepoints. Pharmacokinetics (PK) parameters of GSK2881078 were calculated using non-compartmental methods.
| Liters per hour | GSK2881078 1.0 mg- Female Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|
| Clearance (CL) of GSK2881078 Following Oral Dose in Participants | 0.393 ± 59.5 | 0.476 ± 44.0 |
Blood samples were collected at designated timepoints. PK parameters of GSK2881078 were calculated using non-compartmental methods.
| Liters | GSK2881078 1.0 mg- Female Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|
| Volume of Distribution at Steady State (Vss) of GSK2881078 Following Oral Dose in Participants | 39.4 ± 16.3 | 48.3 ± 29.8 |
Collected over Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until up to Day 132. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo- Female Participants | 0/23 (0%) | 1/23 (4.3%) | 15/23 (65.2%) |
| GSK2881078 1.0 mg- Female Participants | 0/24 (0%) | 2/24 (8.3%) | 18/24 (75%) |
| Placebo- Male Participants | 0/24 (0%) | 2/24 (8.3%) | 13/24 (54.2%) |
| GSK2881078 2.0 mg- Male Participants | 0/25 (0%) | 0/25 (0%) | 17/25 (68%) |
| Event | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Infective exacerbation of chronic obstructive airways diseaseInfections and infestations | 1/23 | 0/24 | 0/24 | 0/25 |
| DiverticulitisInfections and infestations | 0/23 | 0/24 | 1/24 | 0/25 |
| Myocardial infarctionCardiac disorders | 0/23 | 1/24 | 0/24 | 0/25 |
| Cholecystitis acuteHepatobiliary disorders | 0/23 | 1/24 | 0/24 | 0/25 |
| Adenocarcinoma of colonNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/23 | 0/24 | 1/24 | 0/25 |
| Event | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants |
|---|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 6/23 | 7/24 | 2/24 | 3/25 |
| NasopharyngitisInfections and infestations | 5/23 | 2/24 | 1/24 | 1/25 |
| ContusionInjury, poisoning and procedural complications | 3/23 | 1/24 | 0/24 | 0/25 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/23 | 3/24 | 2/24 | 2/25 |
| Back painMusculoskeletal and connective tissue disorders | 0/23 | 3/24 | 0/24 | 2/25 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 1/23 | 2/24 | 0/24 | 3/25 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 0/23 | 0/24 | 2/24 | 1/25 |
| Blood 25-hydroxycholecalciferol decreasedInvestigations | 0/23 | 2/24 | 0/24 | 0/25 |
| HypertensionVascular disorders | 0/23 | 1/24 | 2/24 | 0/25 |
| HypotensionVascular disorders | 0/23 | 0/24 | 2/24 | 0/25 |
| Age, Continuous(Years) | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants | Total |
|---|---|---|---|---|---|
| Mean | 64.7 ± 7.16 | 64.2 ± 7.93 | 64.0 ± 7.27 | 67.2 ± 6.08 | 65.1 ± 7.14 |
| Sex: Female, Male(Participants) | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants | Total |
|---|---|---|---|---|---|
| Female | 23 | 24 | 0 | 0 | 47 |
| Male | 0 | 0 | 24 | 25 | 49 |
| Race/Ethnicity, Customized(Participants) | Placebo- Female Participants | GSK2881078 1.0 mg- Female Participants | Placebo- Male Participants | GSK2881078 2.0 mg- Male Participants | Total |
|---|---|---|---|---|---|
| Black or African American | 0 | 1 | 2 | 2 | 5 |
| White-White/Caucasian/European Heritage | 23 | 23 | 22 | 23 | 91 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Nov 2019, 20 months.
Results were first posted in Jul 2020, 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: GSK2881078