A Phase 3 interventional study of FF/UMEC/VI and ELLIPTA in Asthma, sponsored by GlaxoSmithKline. Active, not recruiting at 67 sites in 9 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
Among 40 studies testing fluticasone furoate in Asthma — none open to participants now, 3 under way, 2 of them phase 3. fluticasone furoate · Asthma.
Among the 40 studies testing fluticasone furoate in Asthma, this one is the 19th largest by planned enrollment, is the only one that started in 2023, is one of 14 in phase 3, and was the 39th registered.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 138 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →None of the 40 studies testing fluticasone furoate in Asthma is open now.
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 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 146 take children under 18; 104 take healthy volunteers.
This study: 12 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →40 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2023.
Median enrollment 102 across the 40 interventional studies. Of the 35 that completed or were terminated, 22 (63%) have results posted.
36 of 40 have an industry lead sponsor. The 4 most frequent:
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
261 studies in Asthma by GlaxoSmithKline: 7 open now, 12 under way, 7 of them phase 3. Of 239 finished, 131 (55%) have results posted.
Among the 261 studies in Asthma by GlaxoSmithKline, this one is the 107th largest by planned enrollment of the 237 interventional ones, is one of 2 that started in 2023, is one of 61 in phase 3, reaches primary completion later than 4 of the 11 other live ones, and was the 244th registered.
GlaxoSmithKline’s Asthma studies by the year they started, since 1999.
1 of the studies testing fluticasone furoate in Asthma that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05757102Phase 3GlaxoSmithKlineA Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma | 2027-01-26 |
Among the 40 studies testing fluticasone furoate in Asthma, from their registry updates:
Among GlaxoSmithKline’s 261 in Asthma:
The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.
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.
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.
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.
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.
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.
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.
Drug: FF/UMEC/VI · Device: ELLIPTA
Device: ELLIPTA · Drug: FF/VI
Drug pages: Fluticasone furoate · GSK573719 · Vilanterol
FF/UMEC/VI will be administered.
FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler
Drug pages: Fluticasone furoate · Vilanterol
FF/VI will be administered.
Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24
FEV1 will be measured using spirometry.
Time frame: Baseline (Week 0) and Week 24
Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale)
ACQ-7 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)), a question on rescue use and an additional item relating to lung function which is calculated based on FEV1. A score of less than or equal to (\<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (\>=)1.5 indicates poorly controlled asthma.
Time frame: Baseline (Week 0) and Week 24
Change from Baseline in Asthma Control Questionnaire (6 items) (ACQ-6) (Scores on a scale)
ACQ-6 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)) and a question on rescue bronchodilator use. A score of less than or equal to (\<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (\>=)1.5 indicates poorly controlled asthma.
Time frame: Baseline (Week 0) and Week 24
Change from Baseline in Asthma Control Questionnaire (5 items) (ACQ-5) (Scores on a scale)
ACQ-5 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation). A score of less than or equal to (\<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (\>=)1.5 indicates poorly controlled asthma.
Time frame: Baseline (Week 0) and Week 24
Number of Participants with a clinically important change from baseline in ACQ-7 Score
ACQ-7 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)), a question on rescue use and an additional item relating to lung function which is calculated based on FEV1. A score of less than or equal to (\<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (\>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score.
Time frame: Week 24
Number of Participants with a clinically important change from baseline in ACQ-6 Score
ACQ-6 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)) and a question on rescue bronchodilator use. A score of less than or equal to (\<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (\>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score.
Time frame: Week 24
Number of Participants with a clinically important change from baseline in ACQ-5 Score
ACQ-5 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation). A score of less than or equal to (\<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (\>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score.
Time frame: Week 24
Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.gsk.com
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Jan 2027, 45 months after the start.
Of 173 industry-sponsored phase 3 interventional studies under Asthma, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 41. This study's planned 45 months is above that.
Counting every sponsor, half of 205 studies reached it within 27 months; a quarter within 14 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. 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