Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Omalizumab

• Registration Number: NCT00180011
• Lead Sponsor: DiMango, Emily, M.D.

Brief Summary

This study will be a randomized, placebo controlled, double blind study to measure the safety and efficacy of a new, injectable asthma medication, omalizumab, in a group of minority with moderate to severe asthma who are not adequately controlled with use of inhaled or oral steroids. Primary endpont will be change in asthma symptom utility index. Secondary endpoints will be changes in asthma Quality of life, asthma exacerbation rate, and lung function over the 12 week treatment period.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-16
• Status Verified: 2012-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-27
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Age 18-30
• Minority Patients
• Moderate or Severe allergic asthma (as defined by the National Asthma Education and Prevention Guidelines(7)]. Allergic asthma will be defined as elevated IgE level (> 100 IU/ml) and skin test sensitivity to at least one common aeroallergen
• asthma control score greater than 1.5 (5) at randomization visit with use of equivalent of at least 1000 mcg fluticasone daily or systemic steroid use
• FEV1 50-90% predicted at screening and randomization visit

Exclusion Criteria

• Active smoking within one year and/or greater than 10-pack year history of smoking
• Women of childbearing age must be using effective contraception
• Malignancy diagnosed within the past 5 years
• Underlying lung disease other than asthma
• Inability to comply with study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
omaluzimab	Omalizumab	-

Primary Outcome Measures

Name	Time	Method
Asthma symptom utility index	6 months

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints will be changes in asthma Quality of Life, asthma exacerbation rate, and lung function over the 12 week treatmet period.	6 months

Trial Locations

Locations (1)

Columbia University; 🇺🇸 New York, New York, United States