A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma

Conditions

• Asthma

Eligibility Criteria

Sex

ALL

Age

12 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• FF/UMEC/VI — DRUG
  FF/UMEC/VI will be administered.
• ELLIPTA — DEVICE
  FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler
• FF/VI — DRUG
  FF/VI will be administered.

Study Details

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.

Key Dates

Start date

Apr 25, 2023

Status verified

Oct 2025

Primary completion

Jan 15, 2027

Completion

Jan 15, 2027

Study Design

Enrollment

292 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Participants receiving FF/UMEC/VI
• Active Comparator: Participants receiving FF/VI

Primary Outcome Measure

Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24 [ Time Frame: Baseline (Week 0) and Week 24 ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (28)

Find similar trials in Birmingham, AL

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