Systemic Corticosteroids Avoidance Study in Severe Asthma Patients
Summary
The overall purpose of this study was to determine the efficacy of fevipiprant (150 mg and 450 mg once daily), compared with placebo, as add-on to standard-of-care asthma therapy, in terms of avoidance of corticosteroid use over 52 weeks.
Timeline
- Start
- 2018-12-13
- Primary completion
- 2020-02-06
- Completion
- 2020-02-06
Outcome
Missed primary endpoint
Stopped: “Company decision”
registry analysis (superiority test); QAW039 150 mg vs Placebo; p = 0.714; Wilcoxon (Mann-Whitney) NCT03629249 ↗
registry analysis (superiority test); QAW039 450 mg vs Placebo; p = 0.734; Wilcoxon (Mann-Whitney) NCT03629249 ↗
registry analysis (superiority test); QAW039 150 mg vs Placebo; p = 0.665; Wilcoxon (Mann-Whitney) NCT03629249 ↗
registry analysis (superiority test); QAW039 450 mg vs Placebo; p = 0.910; Wilcoxon (Mann-Whitney) NCT03629249 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | fevipiprant | Small molecule | 150 mg | Oral |
| Subject | fevipiprant | Small molecule | 450 mg | Oral |