Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma
Summary
Primary Objective: To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in participants with persistent asthma. Secondary Objective: To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.
Timeline
- Start
- 2016-01-27
- Primary completion
- 2018-01-03
- Completion
- 2018-01-03
Outcome
Mixed primary results
registry analysis (superiority test); Placebo vs Dupilumab; p = 0.0336; LS Mean Difference -235.02 (90% CI -414.19 to -55.84) NCT02573233 ↗
registry analysis (superiority test); Placebo vs Dupilumab; p = 0.8400; Rank ANCOVA; note: Threshold for significance at 0.05 level NCT02573233 ↗
registry analysis (superiority test); Placebo vs Dupilumab; p = 0.4795; LS mean difference 13.89 (90% CI -19.00 to 46.78); Linear fixed-effect model NCT02573233 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dupilumab | Monoclonal antibody | 300 mg | Subcutaneous |
| Background | Budesonide | Small molecule | — | Inhaled |
| Background | Fluticasone propionate | Other / unclassified | — | Inhaled |
| Background | Formoterol | Other / unclassified | — | Inhaled |
| Background | Mometasone furoate | Other / unclassified | — | Inhaled |
| Background | Salmeterol | Other / unclassified | — | Inhaled |