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NCT03248128 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Fluticasone Furoate/Vilanterol (FF/VI) Fixed Dose Combination (FDC) Compared to FF Alone in Subjects With Asthma
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 906
- Enrollment target
NCT03248128: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT03248128 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 906 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03248128, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 906 participants
- Enrollment target
Study Summary
The goal of asthma treatment is to achieve and maintain asthma control and to reduce the future risk of exacerbations. Inhaled corticosteroids (ICS) are considered as the most effective anti- inflammatory treatment for all severities of persistent asthma. For children \>=5 years of age and adolescents whose asthma is uncontrolled, low-dose ICS plus adjunctive therapy with long-acting beta agonist (LABA) is considered as effective. Thus, this study is designed to evaluate the efficacy and safety of FF (ICS component)/VI (LABA component) compared to FF alone for the treatment of asthma, in subjects aged 5 to 17 years old currently uncontrolled on ICS. The study will be conducted over a total duration of approximately 29 weeks: 4 week run-in period, 24-week double-blind treatment period and 1-week follow-up period. Subjects will be randomized to receive FDC of FF/VI or FF administered via ELLIPTA® dry powder inhaler (DPI). The dose of both FF/VI and FF alone will be selected based on the age of subjects. Subjects will receive a short acting beta 2 agonist (SABA) (albuterol /salbutamol) as a rescue medication throughout the study. A total of 870 subjects will be randomized in the study. Of this, 652 subjects will be aged 5 to 11 years (cohort A), and 218 will be aged 12 to 17 years inclusive (cohort B). ELLIPTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.
Primary Outcome
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second using a standardized calibrated spirometer. Weighted mean FEV1 was derived using the post-dose assessments (after 30 minutes and 1, 2, 3, 4 hours) with their actual times and using the pre-dose assessment as the 0 hour measurement.
Interventions
- DRUG FF/VI via ELLIPTA DPI
- DRUG FF via ELLIPTA DPI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 906 participants |
| Start Date | 2017-10-20 |
| Est. Completion | 2022-03-21 |
| Phase | Phase 3 |
What the finished NCT03248128 record still lists
NCT03248128 is an interventional study that assigns participants to a tested intervention. The registered 906 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 2 interventions - of which FF/VI via ELLIPTA DPI is the first listed.
NCT03248128 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03248128 about?
NCT03248128 is a clinical study titled "Safety and Efficacy Study of Fluticasone Furoate/Vilanterol (FF/VI) Fixed Dose Combination (FDC) Compared to FF Alone in Subjects With Asthma". The goal of asthma treatment is to achieve and maintain asthma control and to reduce the future risk of exacerbations. Inhaled corticosteroids (ICS) are considered as the most effective anti- inflammatory treatment for all severities of persistent asthma. For children \>=5 years of age and adolescen...
What is the current status of trial NCT03248128?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 906 participants. The study started on 2017-10-20. Estimated completion is 2022-03-21.
What interventions are being tested in trial NCT03248128?
The interventions under investigation include: FF/VI via ELLIPTA DPI (DRUG), FF via ELLIPTA DPI (DRUG).
Who is sponsoring clinical trial NCT03248128?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03248128's enrollment target sits among peer trials
906 347th of 2000 higher than 1,654 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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