NCT00434434

A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma

A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lyophilized and Aged Liquid Omalizumab in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Asthma

Interventions

Type	Name	Description
DRUG	omalizumab	Aged Liquid; subcutaneous repeating dose
DRUG	omalizumab	Lyophilized; subcutaneous repeating dose
DRUG	placebo	Subcutaneous repeating dose

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-02-01
• Completion: 2009-06-01
• First posted: 2007-02-13
• Last updated: 2022-12-14
• Results posted: 2010-05-26