NCT00219323
Completed
Phase 3
Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma
ConditionsAsthma
DrugsOmalizumab
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- Novartis
- Enrollment
- 133
- Locations
- 1
- Primary Endpoint
- Safety of omalizumab
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Safety of omalizumab
Secondary Outcomes
- 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
Study Sites (1)
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