Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma
Part of paid clinical trials in New York, New York.
- Sponsor
- DiMango, Emily, M.D.
- Study ID
- NCT00180011
- Phase
- PHASE2/PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 50 Years
- Healthy Volunteers
- Not accepted
Interventions
- Omalizumab — DRUGinjectable medication
Study Details
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.
Key Dates
- Start date
- Sep 30, 2005
- Status verified
- Feb 2012
- Primary completion
- Feb 29, 2012
- Completion
- Feb 29, 2012
Study Design
- Enrollment
- 18 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: omaluzimab
Primary Outcome Measure
Asthma symptom utility index [ Time Frame: 6 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Columbia University | New York | New York | 10032 | - |
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