A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma
Summary
This was a multicenter, randomized, double-blind, parallel-group, three-arm, placebo-controlled study designed to demonstrate the efficacy of two different formulations of omalizumab compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult subjects with mild allergic asthma.
Timeline
- Start
- 2007-10
- Primary completion
- 2009-02
- Completion
- 2009-06
Outcome
Mixed primary results
registry MEDIAN Lyopholized Omalizumab: 1.85 (-1.10 to 3.50) concentration change NCT00434434 ↗
registry MEDIAN Placebo: 0.36 (-1.09 to 3.09) concentration change NCT00434434 ↗
registry analysis (unspecified test); Lyopholized Omalizumab vs Placebo; p = 0.0133; Wilcoxon (Mann-Whitney) NCT00434434 ↗
registry analysis (unspecified test); Liquid Omalizumab vs Placebo; p = 0.13; Wilcoxon (Mann-Whitney) NCT00434434 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omalizumab | Monoclonal antibody | — | Subcutaneous |