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Omalizumab extension in Japanese pediatric allergic asthma
NCT01328886Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2011
- Primary completion
- Dec 2013
- Countries
- 1
- Sponsor
- Novartis
- Modality
- Monoclonal Antibodies
- Drugs
- omalizumab
- Conditions
- allergic asthma
01
Overview
Phase 3, open-label, single-arm trial of omalizumab in allergic asthma, sponsored by Novartis. Primary endpoint: Adverse Events, Serious Adverse Events, Physical Examination, Medical History, Laboratory Assessments, and Vital Signs. Started Mar 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Omalizumab
Omalizumab add-on therapy
03
Who it enrols
Japanese pediatric patients (6-15 years) who completed the core study (IGE025B1301) and could benefit from continuous treatment.
04
Endpoints
Primary
Adverse Events, Serious Adverse Events, Physical Examination, Medical History, Laboratory Assessments, and Vital Signs
Secondary
Japan Pediatric Asthma Control Program Questionnaire Score
Quality of Life Questionnaire Score
Use of Asthma Long-term Control Medications
Pulmonary Function Tests (FEV1, FVC, V50, V25, FEF25-75%)
Number of Hospitalizations and Emergency Room Visits Due to Asthma
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