Status:
COMPLETED
Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma
Lead Sponsor:
DiMango, Emily, M.D.
Collaborating Sponsors:
Genentech, Inc.
Novartis
Conditions:
Asthma
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
PHASE3
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00180011
Start Date
September 1 2005
End Date
February 1 2012
Last Update
February 28 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University
New York, New York, United States, 10032