Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma.
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00219323
- Lead Sponsor
- Novartis
- Brief Summary
This study will evaluate the safety and efficacy of omalizumab up to 48 weeks in adult patients with moderate to severe bronchial asthma.
THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 133
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
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety of omalizumab
- Secondary Outcome Measures
Name Time Method Pulmonary function parameters measured by spirometer Morning and evening peak expiratory flow (PEF) Symptoms score, treatment score, activities of daily living score, nighttime sleep score, and asthma score
Trial Locations
- Locations (1)
This study is not being conducted in the United States
🇯🇵Tokyo, Japan