A Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function With Benralizumab in Severe, Uncontrolled Asthma Patients With Eosinophilic Inflammation
Summary
The purpose of this study is to investigate the onset and maintenance of effect of benralizumab on lung function, blood eosinophils, asthma control metrics and quality of life during 12-week treatment in patients with uncontrolled, severe asthma with eosinophilic inflammation. A subset of patients will take part in body plethysmography substudy to further investigate the effect on lung function.
Timeline
- Start
- 2016-11-09
- Primary completion
- 2018-08-01
- Completion
- 2018-08-01
Outcome
Missed primary endpoint
registry analysis (superiority test); Benra 30 mg vs Placebo; p = 0.0707; Mean Difference (Final Values) 0.077 (95% CI -0.007 to 0.161); Mixed Models Analysis NCT02869438 ↗
registry analysis (superiority test); Benra 30 mg vs Placebo; p = 0.2847; Mean Difference (Final Values) -0.176 (95% CI -0.505 to 0.153); Mixed Models Analysis NCT02869438 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Benralizumab | Monoclonal antibody | — | Subcutaneous |