A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
NCT05757102 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 292
Last updated 2025-10-07
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
- 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.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-25
- Primary Completion
- 2027-01-15
- Completion
- 2027-01-15
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Chile
- New Zealand
- South Korea
Study Locations
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