Trials / Recruiting
RecruitingNCT05757102
A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
A Phase 3, 24-week, Randomized, Double-blind, Parallel-group Bayesian Dynamic Borrowing Study Comparing the Efficacy, Safety, Tolerability and Pharmacokinetics of FF/UMEC/VI With FF/VI in 12-17-year-old Participants With Inadequately Controlled Asthma on Stable Maintenance Therapy With ICS/LABA
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 292 (estimated)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FF/UMEC/VI | FF/UMEC/VI will be administered. |
| DEVICE | ELLIPTA | FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler |
| DRUG | FF/VI | FF/VI will be administered. |
Timeline
- Start date
- 2023-04-25
- Primary completion
- 2027-01-15
- Completion
- 2027-01-15
- First posted
- 2023-03-07
- Last updated
- 2025-10-07
Locations
42 sites across 6 countries: United States, Argentina, Australia, Chile, New Zealand, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05757102. Inclusion in this directory is not an endorsement.