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NCT03226392 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 704
- Enrollment target
NCT03226392: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT03226392 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 704 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03226392, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 704 participants
- Enrollment target
Study Summary
A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1 second (FEV1) at the end of 12 weeks of treatment.
Primary Outcome
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.
Interventions
- DRUG Placebo
- DRUG QAW039
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 704 participants |
| Start Date | 2017-10-31 |
| Est. Completion | 2019-08-01 |
| Phase | Phase 3 |
What the finished NCT03226392 record still lists
NCT03226392 is an interventional study that assigns participants to a tested intervention. The registered 704 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03226392 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03226392 about?
NCT03226392 is a clinical study titled "Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma". A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with uncontrolled asthma with respect to change f...
What is the current status of trial NCT03226392?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 704 participants. The study started on 2017-10-31. Estimated completion is 2019-08-01.
What interventions are being tested in trial NCT03226392?
The interventions under investigation include: Placebo (DRUG), QAW039 (DRUG).
Who is sponsoring clinical trial NCT03226392?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03226392's enrollment target sits among peer trials
704 506th of 2000 higher than 1,495 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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