Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy

This study will assess the efficacy, safety and tolerability of omalizumab, compared to placebo in 18 to 75 year old Chinese patients with moderate to severe persistent allergic asthma who have inadequate asthma control despite treatment according to GINA (2009) Step 4 therapy.


Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 24-week, Phase III Randomized, Double-blind, Placebocontrolled, Parallel-group, Multicenter Study of Xolair® (Omalizumab) in Patients With Moderate to Severe Persistent Allergic Asthma Who Remain Not Adequately Controlled Despite GINA (2009) Step 4 Therapy
Enrollment: 616
Study Start Date: September 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Omalizumab
- Placebo Comparator: Placebo