Conditions: Asthma
Keywords: Asthma omalizumab Severe persistent allergic asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 406
Healthy volunteers: no

Brief summary:
Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.

Detailed description:

Arms:
arm 1: During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level. arm 2: During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for 32 weeks.

Interventions: intervention 1: Omalizumab intervention 2: Optimized asthma therapy
Intervention descriptions: intervention 1: Omalizumab administered by subcutaneous injection. The dosage received was individualized based on body weight and serum IgE level. intervention 2: Optimized asthma therapy (OAT) according to Global Initiative for Asthma (GINA) 2004 guidelines during the first 4 weeks of the run-in period of the study.

Protocol document: