A Phase 4 interventional study of FF/UMEC/VI and Tiotropium in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 72 sites in 3 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2021-07-15.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
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Among 25 studies testing fluticasone furoate in Pulmonary Disease, Chronic Obstructive — 2 open to participants now, 2 under way, none of them phase 3. fluticasone furoate · Pulmonary Disease, Chronic Obstructive.
Among the 25 studies testing fluticasone furoate in Pulmonary Disease, Chronic Obstructive, this one is the 5th largest by enrollment, is one of 5 that started in 2018, is one of 13 in phase 4, and was the 17th registered.
5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →2 of the 25 studies testing fluticasone furoate in Pulmonary Disease, Chronic Obstructive are open now, in 2 countries. Recruiting first, the newest first:
Western University, Canada · Sites in Canada
Ages 50–85
National Institute of Respiratory Diseases, Mexico · Sites in Mexico
Ages 35–85 · Women only
By country, each count listing its studies:
fluticasone furoate: first FDA approval 2007 (FLONASE SENSIMIST ALLERGY RELIEF), first EMA approval 2008. What it is approved for, and how studies give it, is on its page →
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.
This study: 40 Years and older · 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.
25 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 800 is above the median of 62 across 3,840 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 229 across the 25 interventional studies. Of the 21 that completed or were terminated, 15 (71%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 25 have an industry lead sponsor. The 5 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.
276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline: 7 open now, 8 under way, 5 of them phase 3. Of 264 finished, 141 (53%) have results posted.
Among the 276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline, this one is the 31st largest by enrollment of the 236 interventional ones that give a count, is one of 12 that started in 2018, is one of 38 in phase 4, and was the 250th registered.
GlaxoSmithKline’s Pulmonary Disease, Chronic Obstructive studies by the year they started, since 2000.
1 of the studies testing fluticasone furoate in Pulmonary Disease, Chronic Obstructive that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07192016Western University, Canada129-Xe MRI Study of Single Triple Therapy Inhaler Effects in COPD Patients With Moderate-severe Dyspnea and/or Poor Health Status With High or Low Risk of Exacerbation | 2027-09 |
Add it to your calendar (.ics) → With an account.
Among the 25 studies testing fluticasone furoate in Pulmonary Disease, Chronic Obstructive, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among GlaxoSmithKline’s 276 in Pulmonary Disease, Chronic Obstructive:
This tab as a report to print or save as PDF → With an account.
COPD is a progressive disease characterized by increasing obstruction to airflow and the progressive development of respiratory symptoms including chronic cough, increased sputum production, dyspnea and wheezing. Once-daily triple therapy of an Inhaled Corticosteroid/ Long-acting Muscarinic Receptor Antagonists/ Long Acting Beta-Agonist (ICS/LAMA/LABA) that is combination of FF/UMEC/VI in a single device is being developed with the aim of providing a new treatment option for the management of advanced COPD. The primary purpose of this study is to evaluate lung function and health related quality of life (HRQoL) after 84 days of treatment with a single inhaler triple therapy combination of FF/ UMEC/VI once daily via the ELLIPTA® dry powder inhaler (DPI) compared with tiotropium once daily via HANDIHALER®, in subjects with COPD. Subjects will be randomized 1:1 to receive FF/UMEC/VI or tiotropium in the morning for 84 days. Subjects will also receive albuterol/salbutamol as a rescue therapy throughout the study. Approximately 848 subjects with advanced COPD will be enrolled in the study. The total study duration will be approximately 17 weeks including, 4-week run-in period, 12-week treatment period and a 1-week follow-up period. ELLIPTA is a registered trademark of GlaxoSmithKline (GSK) group of companies. HANDIHALER and RESPIMAT are registered trademarks of Boeringher Ingelheim.
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.
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.
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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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 weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
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.
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.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Eligible subjects will receive FF/UMEC/VI at a dose of 100/62.5/25 microgram (mcg) administered once daily in the morning via ELLIPTA along with placebo to match tiotropium administered once daily in the morning via HANDIHALER. Subjects will self-administer 4 puffs of rescue medication (Albuterol/salbutamol) via metered dose inhaler (MDI).
Drug: FF/UMEC/VI · Drug: Albuterol/salbutamol · Drug: Placebo to match tiotropium · Device: ELLIPTA inhaler · Device: HANDIHALER · Device: MDI
Eligible subjects will receive Tiotropium at a dose of 18 mcg administered once daily in the morning via HANDIHALER along with placebo to match FF/UMEC/VI administered once daily in the morning via ELLIPTA. Subjects will self-administer 4 puffs of rescue medication (Albuterol/salbutamol) via MDI.
Drug: Tiotropium · Drug: Albuterol/salbutamol · Drug: Placebo to match FF/UMEC/VI · Device: ELLIPTA inhaler · Device: HANDIHALER · Device: MDI
Drug pages: Fluticasone furoate · GSK573719 · Vilanterol
A single inhaler triple therapy of FF/UMEC/VI will be provided via ELLIPTA DPI. FF/UMEC/VI will be available as dry white powder with dosing strengths of 100/25/62.5 mcg per blister.
Tiotropium will be provided as a hard gelatin capsule for oral inhalation containing 18 mcg tiotropium bromide blended with lactose, administered via HANDIHALER DPI.
Drug page: Albuterol
Albuterol/salbutamol will be provided as an inhalation via MDI with a spacer or nebules and will be given as a rescue medication throughout the study.
Placebo matching FF/UMEC/VI will be available as a dry white powder of lactose or magnesium stearate, administered via ELLIPTA DPI.
Placebo will be given as hard gelatin capsule for oral inhalation containing lactose, administered via HANDIHALER DPI.
ELLIPTA DPI will contain two individual blister strips with 30 blisters per strip. FF/UMEC/VI and placebo to match FF/UMEC/VI will be administered to the subjects using ELLIPTA DPI.
Tiotropium and placebo to match tiotropium will be administered to the subjects using HANDIHALER DPI.
Albuterol/salbutamol will be provided as a rescue medication throughout the study using MDI.
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 85
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 was defined as the mean of the two planned spirometry FEV1 measurements. Change from Baseline in trough FEV1 on Day 85 was calculated by subtracting Baseline FEV1 value from the trough FEV1 value on Day 85. Baseline FEV1 was defined as the mean of the two assessments made at 30 and 5 minutes pre-dose on Day 1.
Time frame: Baseline (Day 1 [Pre-dose at 30 minutes and 5 minutes]) and Day 85
Change From Baseline in Trough FEV1 on Day 28
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 28 was defined as the average of the two pre-dose FEV1 measurements recorded before the morning dose of randomized study medication on Day 28. Change from Baseline in trough FEV1 on Day 28 was calculated by subtracting Baseline FEV1 value from the trough FEV1 value on Day 28. Baseline FEV1 was defined as the mean of the two assessments made at 30 and 5 minutes pre-dose on Day 1.
Time frame: Baseline (Day 1 [Pre-dose at 30 minutes and 5 minutes]) and Day 28
Change From Baseline in Trough FEV1 on Day 84
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 84 was defined as the average of the two pre-dose FEV1 measurements recorded before the morning dose of randomized study medication on Day 84. Change from Baseline in trough FEV1 on Day 84 was calculated by subtracting Baseline FEV1 value from the trough FEV1 value on Day 84. Baseline FEV1 was defined as the mean of the two assessments made at 30 and 5 minutes pre-dose on Day 1.
Time frame: Baseline (Day 1 [Pre-dose at 30 minutes and 5 minutes]) and Day 84
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other important medical event according to medical or scientific judgement was categorized as SAE.
Time frame: Up to Day 95
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were assessed in the sitting position after approximately 5 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-first-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and Day 84
Change From Baseline in Pulse Rate
Pulse rate was assessed in the sitting position after approximately 5 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-first-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and Day 84
This was a randomized, multicenter, parallel group study where participants with chronic obstructive pulmonary disease (COPD) were randomized to receive either fluticasone furoate/umeclidinium/vilanterol or tiotropium in a 1:1 ratio. The study was conducted across 68 centers in 3 countries.
| Milestone | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Tiotropium 18 mcg |
|---|---|---|
| Started | 400 | 400 |
| Received study treatment | 400 | 399 |
| Completed | 383 | 387 |
| Not completed | 17 | 13 |
| Withdrew: Adverse event | 6 | 3 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Physician decision | 3 | 2 |
| Withdrew: Withdrawal by subject | 5 | 7 |
| Withdrew: Investigator site closed | 1 | 0 |
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 was defined as the mean of the two planned spirometry FEV1 measurements. Change from Baseline in trough FEV1 on Day 85 was calculated by subtracting Baseline FEV1 value from the trough FEV1 value on Day 85. Baseline FEV1 was defined as the mean of the two assessments made at 30 and 5 minutes pre-dose on Day 1.
| Liters | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Tiotropium 18 mcg |
|---|---|---|
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 85 | 0.115 ± 0.0119 | 0.020 ± 0.0117 |
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 28 was defined as the average of the two pre-dose FEV1 measurements recorded before the morning dose of randomized study medication on Day 28. Change from Baseline in trough FEV1 on Day 28 was calculated by subtracting Baseline FEV1 value from the trough FEV1 value on Day 28. Baseline FEV1 was defined as the mean of the two assessments made at 30 and 5 minutes pre-dose on Day 1.
| Liters | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Tiotropium 18 mcg |
|---|---|---|
| Change From Baseline in Trough FEV1 on Day 28 | 0.115 ± 0.0102 | -0.007 ± 0.0101 |
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 84 was defined as the average of the two pre-dose FEV1 measurements recorded before the morning dose of randomized study medication on Day 84. Change from Baseline in trough FEV1 on Day 84 was calculated by subtracting Baseline FEV1 value from the trough FEV1 value on Day 84. Baseline FEV1 was defined as the mean of the two assessments made at 30 and 5 minutes pre-dose on Day 1.
| Liters | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Tiotropium 18 mcg |
|---|---|---|
| Change From Baseline in Trough FEV1 on Day 84 | 0.105 ± 0.0113 | 0.018 ± 0.0111 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other important medical event according to medical or scientific judgement was categorized as SAE.
| Participants | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Tiotropium 18 mcg |
|---|---|---|
| Non-SAEs | 31 | 29 |
| SAEs | 13 | 11 |
SBP and DBP were assessed in the sitting position after approximately 5 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-first-dose assessment with a non-missing value, including those from unscheduled visits.
| Millimeters of mercury | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Tiotropium 18 mcg |
|---|---|---|
| SBP | -0.3 ± 12.53 | -0.1 ± 11.02 |
| DBP | -0.3 ± 8.17 | -0.7 ± 7.88 |
Pulse rate was assessed in the sitting position after approximately 5 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-first-dose assessment with a non-missing value, including those from unscheduled visits.
| Beats per minute | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Tiotropium 18 mcg |
|---|---|---|
| Change From Baseline in Pulse Rate | 0.2 ± 8.55 | 0.8 ± 8.51 |
Collected over Non-SAEs and SAEs were reported from start of study treatment and up to 95 days. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | 2/400 (0.5%) | 13/400 (3.3%) | 31/400 (7.8%) |
| Tiotropium 18 mcg | 1/399 (0.3%) | 11/399 (2.8%) | 29/399 (7.3%) |
| Event | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Tiotropium 18 mcg |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 5/400 | 3/399 |
| PneumoniaInfections and infestations | 1/400 | 3/399 |
| Atrial fibrillationCardiac disorders | 0/400 | 1/399 |
| Pancreatitis acuteGastrointestinal disorders | 1/400 | 1/399 |
| Small intestinal obstructionGastrointestinal disorders | 1/400 | 1/399 |
| Cholecystitis acuteHepatobiliary disorders | 0/400 | 1/399 |
| Diabetes mellitus inadequate controlMetabolism and nutrition disorders | 0/400 | 1/399 |
| Haemorrhagic strokeNervous system disorders | 0/400 | 1/399 |
| Ischaemic strokeNervous system disorders | 0/400 | 1/399 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 1/400 | 1/399 |
| Event | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Tiotropium 18 mcg |
|---|---|---|
| HeadacheNervous system disorders | 18/400 | 22/399 |
| NasopharyngitisInfections and infestations | 16/400 | 8/399 |
Baseline characteristics were presented for all randomized participants including one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm.
| Age, Continuous(Years) | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Tiotropium 18 mcg | Total |
|---|---|---|---|
| Mean | 66.2 ± 8.08 | 66.1 ± 7.78 | 66.2 ± 7.93 |
| Sex: Female, Male(Participants) | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Tiotropium 18 mcg | Total |
|---|---|---|---|
| Female | 126 | 131 | 257 |
| Male | 274 | 269 | 543 |
| Race/Ethnicity, Customized(Participants) | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Tiotropium 18 mcg | Total |
|---|---|---|---|
| African American/African Heritage | 10 | 12 | 22 |
| White - White/Caucasian/European Heritage | 390 | 388 | 778 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study is available via the Clinical Study Data Request site
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · www.clinicalstudydatarequest.com
Ran from Mar 2018 to primary completion in Jul 2019, 15 months.
Results were first posted in Apr 2020, 9 months after primary completion.
Of 71 industry-sponsored phase 4 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 22. This study's 15 months is close to that.
Counting every sponsor, half of 157 studies reached it within 19 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Fluticasone furoate · GSK573719 · Vilanterol · Tiotropium
Pulmonary Disease, Chronic Obstructive →