A Phase 4 interventional study of budesonide/formoterol and albuterol/salbutamol in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 57 sites in 4 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2020-10-28.
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 7th largest by enrollment, is one of 5 that started in 2018, is one of 13 in phase 4, and was the 18th 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 729 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 35th 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 251st 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.
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 [100/62.5/25 microgram (mcg)] once daily via the ELLIPTA™ compared with a multiple inhaler combination therapy of Symbicort Metered Dose Inhaler (MDI) (budesonide/formoterol 320/9 mcg) twice daily plus Spiriva HandiHaler (tiotropium 18 mcg) once daily. The study will inform healthcare providers that subjects can be effectively and safely switched to FF/UMEC/VI single inhaler therapy from a multiple inhaler triple therapy regimen of Symbicort MDI and Spiriva Handihaler. Eligible subjects will enter a 4-week run-in period during which they will be administered budesonide/formoterol (320/9 mcg) twice daily plus tiotropium (18 mcg) once daily plus placebo via ELLIPTA. Following the run-in period, subjects will be randomized to receive one of the following study treatments for 84 days: 1) FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning plus two inhalations of placebo to match budesonide/formoterol via MDI, twice daily plus placebo to match tiotropium via HandiHaler once daily in the morning or 2) Budesonide/formoterol 320/9 mcg via MDI, twice daily plus tiotropium 18 mcg via HandiHaler once daily in the morning plus placebo via ELLIPTA once daily in the morning. Subjects will then enter a one week follow-up period. The total duration for a subject in the study will be approximately 17 weeks. ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies.
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.
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.
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.
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.
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.
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.
Subjects will receive budesonide/formoterol (320/9 mcg) twice daily plus tiotropium (18 mcg) once daily plus placebo via ELLIPTA during the 4-week run-in period. Subjects will be administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning plus placebo to match budesonide/formoterol via MDI, two inhalations twice daily plus placebo to match tiotropium via HandiHaler once daily in the morning for 84 days in the treatment period.
Drug: budesonide/formoterol · Drug: albuterol/salbutamol · Drug: FF/UMEC/VI · Drug: Placebo to match budesonide/formoterol · Drug: tiotropium · Drug: placebo to match tiotropium · Device: ELLIPTA · Device: MDI · Device: HandiHaler
Subjects will receive budesonide/formoterol (320/9 mcg) twice daily plus tiotropium (18 mcg) once daily plus placebo via ELLIPTA during the 4-week run-in period. Subjects will be administered budesonide/formoterol 160/4.5 mcg via MDI, two inhalations twice daily plus tiotropium 18 mcg via HandiHaler once daily in the morning plus placebo via ELLIPTA once daily in the morning for 84 days in the treatment period.
Drug: budesonide/formoterol · Drug: albuterol/salbutamol · Drug: tiotropium · Drug: Placebo to match FF/UMEC/VI · Device: ELLIPTA · Device: MDI · Device: HandiHaler
Drug pages: Budesonide · Formoterol
Subjects will be administered two inhalations of budesonide/formoterol via MDI twice daily
Drug page: Albuterol
Subjects will be provided short-acting albuterol/salbutamol as-rescue medication to be used on an as-needed basis throughout the study.
Drug pages: Fluticasone furoate · GSK573719 · Vilanterol
Subjects will receive FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning
Subjects will be administered two inhalations of matching placebo twice daily via MDI
Subjects will receive tiotropium (18 mcg) once daily in the morning via HandiHaler device
Matching placebo to FF/UMEC/VI will be administered via ELLIPTA once daily in the morning.
Subjects will receive tiotropium matching placebo via Handihaler once daily in the morning
Subjects will receive FF/UMEC/VI 100/62.5/25 mcg and matching placebo via ELLIPTA in the treatment period. Budesonide/formoterol plus tiotropium once daily plus placebo will be administered via ELLIPTA during the run-in period.
Subjects will receive budesonide/formoterol and placebo to match budesonide/formoterol via MDI in the treatment period.
Subjects will be administered tiotropium (18 mcg) or placebo to match tiotropium via HandiHaler during the treatment period.
Weighted Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 0-24 Hours at Week 12 for Modified Per Protocol (mPP) Population
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period at Week 12. Weighted mean change from Baseline at week 12 was calculated by subtracting weighted mean FEV1 at week 12 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.
Time frame: Baseline and Week 12
Weighted Mean Change From Baseline in FEV1 Over 0-24 Hours at Week 12 for ITT Population
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period at Week 12. Weighted mean change from Baseline at week 12 was calculated by subtracting weighted mean FEV1 at week 12 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.
Time frame: Baseline and Week 12
Change From Baseline in Trough FEV1 on Day 2, Day 28, Day 84 and Day 85
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. For Day 2 and Day 85, trough FEV1 was defined as the mean of the 23-hour and 24-hour serial spirometry FEV1 measurements. For Day 28 and Day 84, trough FEV1 was defined as the average of the pre-dose FEV1 measurements recorded before the morning dose of randomized study treatment. Change from Baseline in trough FEV1 was calculated by subtracting post-dose trough FEV1 value from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The treatment effect to be estimated for trough FEV1 was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.
Time frame: Baseline, Days 2, 28, 84 and 85
Weighted Mean Change From Baseline in FEV1 Over 0-24 Hours on Day 1
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period on Day 1. Weighted mean change from Baseline on Day 1 was calculated by subtracting weighted mean FEV1 on Day 1 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.
Time frame: Baseline and Day 1
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 budesonide/formoterol plus tiotropium in a 1:1 ratio. The study was conducted across 65 centers in 4 countries.
| Milestone | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg |
|---|---|---|
| Started | 363 | 365 |
| Completed | 350 | 347 |
| Not completed | 13 | 18 |
| Withdrew: Adverse event | 5 | 3 |
| Withdrew: Lost to follow-up | 0 | 5 |
| Withdrew: Physician decision | 1 | 3 |
| Withdrew: Withdrawal by subject | 7 | 7 |
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period at Week 12. Weighted mean change from Baseline at week 12 was calculated by subtracting weighted mean FEV1 at week 12 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.
| Liters | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg |
|---|---|---|
| Weighted Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 0-24 Hours at Week 12 for Modified Per Protocol (mPP) Population | 0.045 ± 0.0101 | 0.030 ± 0.0101 |
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. For Day 2 and Day 85, trough FEV1 was defined as the mean of the 23-hour and 24-hour serial spirometry FEV1 measurements. For Day 28 and Day 84, trough FEV1 was defined as the average of the pre-dose FEV1 measurements recorded before the morning dose of randomized study treatment. Change from Baseline in trough FEV1 was calculated by subtracting post-dose trough FEV1 value from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The treatment effect to be estimated for trough FEV1 was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.
| Liters | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg |
|---|---|---|
| Day 2, n=358,359 | 0.008 ± 0.0098 | 0.018 ± 0.0098 |
| Day 28, n=355,353 | 0.046 ± 0.0088 | -0.015 ± 0.0088 |
| Day 84, n=344,340 | 0.040 ± 0.0094 | -0.018 ± 0.0094 |
| Day 85, n=341,337 | 0.026 ± 0.0099 | -0.012 ± 0.0099 |
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period on Day 1. Weighted mean change from Baseline on Day 1 was calculated by subtracting weighted mean FEV1 on Day 1 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.
| Liters | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg |
|---|---|---|
| Weighted Mean Change From Baseline in FEV1 Over 0-24 Hours on Day 1 | 0.054 ± 0.0078 | 0.063 ± 0.0077 |
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period at Week 12. Weighted mean change from Baseline at week 12 was calculated by subtracting weighted mean FEV1 at week 12 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.
| Liters | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg |
|---|---|---|
| Weighted Mean Change From Baseline in FEV1 Over 0-24 Hours at Week 12 for ITT Population | 0.046 ± 0.0097 | 0.032 ± 0.0098 |
Collected over Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | 0/363 (0%) | 29/363 (8%) | 18/363 (5%) |
| Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg | 0/365 (0%) | 16/365 (4.4%) | 12/365 (3.3%) |
| Event | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 15/363 | 3/365 |
| PneumoniaInfections and infestations | 4/363 | 2/365 |
| CellulitisInfections and infestations | 2/363 | 0/365 |
| SepsisInfections and infestations | 2/363 | 1/365 |
| Cerebrovascular accidentNervous system disorders | 2/363 | 0/365 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 2/363 | 0/365 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 2/363 | 0/365 |
| Acute myocardial infarctionCardiac disorders | 0/363 | 2/365 |
| Cardiac failure congestiveCardiac disorders | 1/363 | 0/365 |
| Coronary artery diseaseCardiac disorders | 1/363 | 0/365 |
| Event | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg |
|---|---|---|
| NasopharyngitisInfections and infestations | 18/363 | 12/365 |
Intent-to-Treat (ITT) Population comprised of all randomized participants, excluding those who were randomized in error.
| Age, Continuous(Years) | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg | Total |
|---|---|---|---|
| Mean | 65.4 ± 7.90 | 64.9 ± 8.06 | 65.2 ± 7.98 |
| Sex: Female, Male(Participants) | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg | Total |
|---|---|---|---|
| Female | 180 | 164 | 344 |
| Male | 183 | 201 | 384 |
| Race/Ethnicity, Customized(Participants) | Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg | Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg | Total |
|---|---|---|---|
| African American/African Heritage | 34 | 33 | 67 |
| American Indian Or Alaska Native | 0 | 1 | 1 |
| Asian - Central/South Asian Heritage | 1 | 0 | 1 |
| Asian - South East Asian Heritage | 0 | 1 | 1 |
| White - Arabic/North African Heritage | 0 | 2 | 2 |
| White - White/Caucasian/European | 327 | 328 | 655 |
| Multiple | 1 | 0 | 1 |
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 Jun 2018 to primary completion in Mar 2019, 8 months.
Results were first posted in Feb 2020, 10 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 8 months is below 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 Oct 2020. 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
Pulmonary Disease, Chronic Obstructive →