A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
Phase 3
292
about 3.7 years
12–17
28 sites in AL, AZ, CA +12
What this study is about
Researchers are testing whether a new asthma treatment called FF/UMEC/VI is better than an existing treatment called FF/VI for children aged 12 to 17 with asthma. The trial will last for about 1361 days and involve around 292 participants.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take FF/UMEC/VI
- 2.Take FF/VI
- 3.Use ELLIPTA
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24
Secondary: Change from Baseline in Asthma Control Questionnaire (5 items) (ACQ-5) (Scores on a scale), Change from Baseline in Asthma Control Questionnaire (6 items) (ACQ-6) (Scores on a scale), Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale), Number of Participants with a clinically important change from baseline in ACQ-5 Score, Number of Participants with a clinically important change from baseline in ACQ-6 Score, Number of Participants with a clinically important change from baseline in ACQ-7 Score
Respiratory