Status:
COMPLETED
Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy
Lead Sponsor:
University of Mississippi Medical Center
Collaborating Sponsors:
Novartis
Conditions:
Asthma
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab(administered per US product label), when compared to placebo, will provide the participants w...
Detailed Description
Omalizumab is an FDA approved anti-IgE drug used to treat allergic asthma. This study is designed to give omalizumab 13 weeks prior to administering rapid build up of specific allergy shot, with an ov...
Eligibility Criteria
Inclusion
- clinical diagnosis and history of moderate persistent allergic asthma
- body weight \>/= 20kg and \</= 150kg
- Total serum IgE \>/= 30 and \</= 700IU/mL
- on a stable asthma treatment including corticosteroids for the preceding 4 weeks
- non smoker for at least 1 year prior to visit 1
Exclusion
- patients with severe asthma
- history of immunotherapy to any allergen within the past 3 years
- history of anaphylactic allergic reaction
- upper respiratory tract infection
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00329381
Start Date
May 1 2006
End Date
October 1 2007
Last Update
June 4 2008
Active Locations (1)
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1
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216