Study of Omalizumab in Moderate to Severe Bronchial Asthma
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00232050
- Lead Sponsor
- Novartis
- Brief Summary
This study will evaluate the safety and efficacy of omalizumab up to 16 weeks in adult patients with moderate to severe bronchial asthma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 327
Inclusion Criteria
- Allergic asthma patients
- Inadequately controlled patients
Exclusion Criteria
-
- History of severe anaphylactoid or anaphylactic reactions
- Previous treatment with omalizumab
- History of cancer or cancer
Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Morning peak expiratory flow (PEF) at baseline and end of treatment.
- Secondary Outcome Measures
Name Time Method Pulmonary function parameters measured by spirometer Frequency of rescue medication use Symptom score Activities of daily living score Nighttime sleep score