A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. This study will test the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma.
Primary Outcome Measures:
- The primary safety objective is to confirm the safety of omalizumab during
- the 52 week double-blind treatment period and 16 week follow-up period
- The primary efficacy objective is to demonstrate the effect of omalizumab
- on the clinically significant asthma exacerbation rate during the 24 week
- double-blind fixed steroid treatment
Secondary Outcome Measures:
- change in nocturnal clinical symptom score (24 week double-blind fixed steroid treatment period)
- clinically significant asthma exacerbation rate (52 week double-blind treatment period)
- change in beta-agonist rescue medication use (24 week double-blind fixed steroid treatment period)
- change in quality of life (24 week double-blind fixed steroid treatment period)
| Estimated Enrollment: |
570 |
| Study Start Date: |
March 2004 |
| Estimated Study Completion Date: |
April 2008 |
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1: Active Comparator
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Drug: Omalizumab
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2: Placebo Comparator
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Drug: placebo
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This study is designed to provide one year efficacy and safety data for subcutaneous (SQ) omalizumab, compared to placebo in children (6 to < 12 years) with moderate to severe persistent asthma who have inadequate asthma control despite treatment according to NHLBI step 3 or 4 (at least medium dose inhaled corticosteroids with or without other controller asthma medications).
Purpose
