Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy
NCT ID: NCT00329381
Last Updated: 2008-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
14 participants
INTERVENTIONAL
2006-05-31
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Placebo will be compared to Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
Xolair
Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
2
Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
Xolair
Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
Interventions
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Xolair
Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
Xolair
Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* history of immunotherapy to any allergen within the past 3 years
* history of anaphylactic allergic reaction
* upper respiratory tract infection
18 Years
55 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
University of Mississippi Medical Center
OTHER
Responsible Party
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University of Mississippi Medical Center
Principal Investigators
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Gailen D. Marshall, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
University of Mississippi Medical Center
Locations
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University of Mississippi Medical Center
Jackson, Mississippi, United States
Countries
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Other Identifiers
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CiGE025AUS23
Identifier Type: -
Identifier Source: org_study_id
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