Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma

Phase 3

Completed

• Conditions: Asthma

• Registration Number: NCT00046748
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The purpose of this study is to determine the effect of omalizumab, compared to placebo, on clinically significant asthma exacerbation rates in adolescents and adults with asthma.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2002-10-02
• Study First Submitted QC: 2002-10-03
• Study First Posted: 2002-10-04
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-31
• Last Update Posted: 2017-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 484

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinically significant asthma exacerbation

Secondary Outcome Measures

Name	Time	Method
Quality of Life assessment at baseline, last visit
Medical resource utilization
Time to first asthma exacerbation
Frequency of asthma rescue medication use
Safety/tolerability of omalizumab