A Phase 4 interventional study of FF/UMEC/VI and Inhaled Corticosteroid in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 143 sites in 5 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2020-09-07.
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 3rd largest by enrollment, is one of 5 that started in 2018, is one of 13 in phase 4, and was the 16th 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 3,109 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 4th 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 246th 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 assess the effectiveness of TRELEGY ELLIPTA relative to non-ELLIPTA Multiple Inhaler Triple Therapies (MITT) for Chronic Obstructive Pulmonary Disease (COPD) control within the usual clinical practice setting. The study will be conducted once TRELEGY ELLIPTA has been approved in the countries in which the study will be conducted and is available commercially. This is a randomized, open-label, effectiveness, phase 4 study of 24 weeks' duration in COPD subjects to evaluate TRELEGY ELLIPTA (fluticasone furoate [FF]/vilanterol [VI]/umeclidinium bromide [UMEC]: 100 microgram [mcg]/62.5 mcg/25 mcg) inhalation powder taken once daily using a single ELLIPTA inhaler compared with any non-ELLIPTA MITT in the usual care setting. Effectiveness of TRELEGY ELLIPTA will be assessed by comparing proportion of COPD Assessment Test (CAT) responders at Week 24 between two treatment groups. TRELEGY and ELLIPTA are trademarks of GlaxoSmithKline (GSK) group of companies. The study will enroll approximately 3000 subjects.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
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.
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.
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.
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.
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.
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 a blended combination of FF in the first strip (100 mcg per blister) and UMEC/VI in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the morning in the same TRELEGY ELLIPTA Dry Powder Inhaler (DPI) via inhalation route for a period of 24 weeks. Study treatment may be augmented with other prescribed COPD medications such as including rescue medications, which will be prescribed and obtained according to usual practice.
Drug: FF/UMEC/VI · Drug: COPD rescue medications
Eligible subjects will receive the ICS/LAMA/LABA products twice daily and dosing regimens as prescribed by their physician for a period of 24 weeks. Study treatment may be augmented with other prescribed COPD medications such as including rescue medications, which will be prescribed and obtained according to usual practice.
Drug: Inhaled Corticosteroid · Drug: LAMA · Drug: LABA · Drug: COPD rescue medications
Drug pages: Fluticasone furoate · GSK573719 · Vilanterol
FF is a dry white powder containing 100 mcg GW685698 blended with lactose in one blister in the first strip of the DPI. UMEC/VI is a dry white powder containing 62.5 mcg of UMEC and 25 mcg of VI per blister, both blended together with lactose and magnesium stearate in the second strip of the DPI.
Inhaled Corticosteroid (ICS) as prescribed by the physician.
LAMA as prescribed by the physician.
LABA as prescribed by the physician.
Rescue medications for COPD will be prescribed and obtained according to usual practice.
Number of Responders and Non-responders Based on the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 24 and Number of Participants With Imputed CAT Score at Week 24
The CAT is a 8-item questionnaire, used to measure the health status of par. with COPD. Par. rated their experience on a 6-point scale: 0 (no impact) to 5 (maximum impact). CAT score was calculated by summing the non-missing scores of the 8 items with a range of 0-40. Higher scores indicate greater disease impact. Responders were par. who had a change from Baseline score \>=2 at Week 24. Non-responders were the par. who had change from Baseline score \<2 at Week 24. Change from Baseline was calculated as Week 24 value minus the Baseline value (Day 1). A composite strategy was applied when intercurrent events of randomized treatment modification, change in pulmonary rehabilitation or start of oxygen therapy occurred, otherwise a treatment policy strategy was applied. Missing Week 24 CAT data were imputed assuming missing at random and are presented in a separate category. Number of responders, non-responders based on CAT and par. with imputed CAT score at Week 24 are presented.
Time frame: At Week 24
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24
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 value recorded at Day 1. Change from Baseline was calculated as FEV1 value at Week 24 minus the Baseline value. A treatment policy strategy was used for the intercurrent events of randomized treatment discontinuation, randomized treatment modification, change of pulmonary rehabilitation status and start of oxygen therapy. Only those participants with non-missing covariates were included in the analysis.
Time frame: Baseline (Day 1) and at Week 24
Percentage of Participants Making at Least 1 Critical Error in Inhalation Technique at Week 24
Participants were trained on the correct use of their inhaler devices. All participants who had spirometry measured were to have an assessment of inhaler errors. During the assessment, participants were asked to demonstrate inhaler use when taking their regular dose of medication. A critical error is defined as an error that is most likely to result in no or significantly reduced medication being inhaled. These errors were recorded in an error checklist, during the assessment. A hypothetical strategy was used for the intercurrent event of randomized treatment modification. Percentage of participants making at least 1 critical error in inhalation technique at the Week 24 is presented.
Time frame: At Week 24
This was a Phase IV, open-label, randomized study to evaluate the effectiveness of TRELEGY ELLIPTA relative to non-ELLIPTA multiple inhaler triple therapies (MITT) for chronic obstructive pulmonary disease (COPD) control within the usual clinical practice setting. TRELEGY and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.
| Milestone | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | Non-ELLIPTA MITT |
|---|---|---|
| Started | 1545 | 1547 |
| Randomized but did not start ip | 1 | 0 |
| Completed ip | 1256 | 1359 |
| Not completed ip | 288 | 188 |
| Withdrew ip (wip): lost to follow-up | 15 | 24 |
| Wip: protocol deviation | 0 | 2 |
| Wip: adverse event | 112 | 29 |
| Wip: lack of efficacy | 56 | 28 |
| Wip: physician decision | 14 | 27 |
| Wip: withdrawal by participant | 91 | 78 |
| Completed | 1498 | 1493 |
| Not completed | 47 | 54 |
| Withdrew: Adverse event | 9 | 9 |
| Withdrew: Lack of efficacy | 3 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Lost to follow-up | 18 | 25 |
| Withdrew: Physician decision | 2 | 1 |
| Withdrew: Withdrawal by subject | 15 | 17 |
The CAT is a 8-item questionnaire, used to measure the health status of par. with COPD. Par. rated their experience on a 6-point scale: 0 (no impact) to 5 (maximum impact). CAT score was calculated by summing the non-missing scores of the 8 items with a range of 0-40. Higher scores indicate greater disease impact. Responders were par. who had a change from Baseline score \>=2 at Week 24. Non-responders were the par. who had change from Baseline score \<2 at Week 24. Change from Baseline was calculated as Week 24 value minus the Baseline value (Day 1). A composite strategy was applied when intercurrent events of randomized treatment modification, change in pulmonary rehabilitation or start of oxygen therapy occurred, otherwise a treatment policy strategy was applied. Missing Week 24 CAT data were imputed assuming missing at random and are presented in a separate category. Number of responders, non-responders based on CAT and par. with imputed CAT score at Week 24 are presented.
| Participants | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | Non-ELLIPTA MITT |
|---|---|---|
| Responders | 731 | 616 |
| Non-responders | 756 | 835 |
| Participants with imputed CAT score | 52 | 92 |
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 value recorded at Day 1. Change from Baseline was calculated as FEV1 value at Week 24 minus the Baseline value. A treatment policy strategy was used for the intercurrent events of randomized treatment discontinuation, randomized treatment modification, change of pulmonary rehabilitation status and start of oxygen therapy. Only those participants with non-missing covariates were included in the analysis.
| Liters | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | Non-ELLIPTA MITT |
|---|---|---|
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24 | 1.446 ± 0.0105 | 1.396 ± 0.0108 |
Participants were trained on the correct use of their inhaler devices. All participants who had spirometry measured were to have an assessment of inhaler errors. During the assessment, participants were asked to demonstrate inhaler use when taking their regular dose of medication. A critical error is defined as an error that is most likely to result in no or significantly reduced medication being inhaled. These errors were recorded in an error checklist, during the assessment. A hypothetical strategy was used for the intercurrent event of randomized treatment modification. Percentage of participants making at least 1 critical error in inhalation technique at the Week 24 is presented.
| Percentage of Participants | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | Non-ELLIPTA MITT |
|---|---|---|
| Percentage of Participants Making at Least 1 Critical Error in Inhalation Technique at Week 24 | 6 | 3 |
Collected over Serious adverse events (SAEs) and non-serious AEs (non-SAEs) were collected from the start of study treatment up to Week 24. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | 8/1,545 (0.5%) | 114/1,545 (7.4%) | 32/1,545 (2.1%) |
| Non-Ellipta MITT | 8/1,547 (0.5%) | 114/1,547 (7.4%) | 3/1,547 (0.2%) |
| Event | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | Non-Ellipta MITT |
|---|---|---|
| PneumoniaInfections and infestations | 26/1545 | 30/1547 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 26/1545 | 28/1547 |
| Infective exacerbation of chronic obstructive airways diseaseInfections and infestations | 6/1545 | 9/1547 |
| Cardiac failureCardiac disorders | 3/1545 | 7/1547 |
| Acute myocardial infarctionCardiac disorders | 5/1545 | 5/1547 |
| Myocardial infarctionCardiac disorders | 5/1545 | 2/1547 |
| Atrial fibrillationCardiac disorders | 4/1545 | 5/1547 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/1545 | 4/1547 |
| SepsisInfections and infestations | 3/1545 | 2/1547 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 3/1545 | 1/1547 |
| Event | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | Non-Ellipta MITT |
|---|---|---|
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 32/1545 | 3/1547 |
| Age, Continuous(Years) | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | Non-ELLIPTA MITT | Total |
|---|---|---|---|
| Mean | 67.8 ± 8.78 | 67.8 ± 8.59 | 67.8 ± 8.68 |
| Sex: Female, Male(Participants) | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | Non-ELLIPTA MITT | Total |
|---|---|---|---|
| Female | 708 | 729 | 1437 |
| Male | 837 | 818 | 1655 |
| Race/Ethnicity, Customized(Participants) | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | Non-ELLIPTA MITT | Total |
|---|---|---|---|
| Asian- Central/South Asian Heritage | 12 | 7 | 19 |
| Asian- East Asian Heritage | 0 | 1 | 1 |
| Asian- South East Asian Heritage | 1 | 6 | 7 |
| Black or African American | 3 | 4 | 7 |
| White- Arabic/North African Heritage | 6 | 7 | 13 |
| White- White/Caucasian/European Heritage | 1523 | 1521 | 3044 |
| White and Black or African American | 0 | 1 | 1 |
Showing the first 100 of 143 sites across 5 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
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 ↗ · clinicalstudydatarequest.com
Ran from Apr 2018 to primary completion in Oct 2019, 17 months.
Results were first posted in Sep 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 17 months is above 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 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 →