NCT00232050
Completed
Phase 3
Study of Omalizumab in Moderate to Severe Bronchial Asthma
ConditionsAsthma
DrugsOmalizumab
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- Novartis
- Enrollment
- 327
- Primary Endpoint
- Morning peak expiratory flow (PEF) at baseline and end of treatment.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
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
Morning peak expiratory flow (PEF) at baseline and end of treatment.
Secondary Outcomes
- Pulmonary function parameters measured by spirometer
- Frequency of rescue medication use
- Symptom score
- Activities of daily living score
- Nighttime sleep score
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