Status:
WITHDRAWN
Correlation Between IgE Parameters and the Response to Omalizumab in Subjects With Severe Asthma
Lead Sponsor:
Carmel Medical Center
Conditions:
Severe Allergic Asthma
Eligibility:
All Genders
18-75 years
Brief Summary
Omalizumab is an anti-IgE recombinant humanized monoclonal antibody.The efficacy and tolerability of omalizumab have been demonstrated in patients with moderate-to-severe and allergic (IgE-mediated) a...
Detailed Description
Omalizumab represents a new therapeutic approach for IgE-mediated disease. Omalizumab is an anti-IgE recombinant humanized monoclonal antibody designed to treat IgE-mediated disease by reducing the co...
Eligibility Criteria
Inclusion
- Subjects who (or as appropriate whose legal guardian) have been informed of the study procedures and medications and have given their written informed consent
- Subjects with severe allergic asthma that based on standard practice have been assigned to omalizumab treatment and fulfill all requirements for such treatment
- The requirements include:
- Uncontrolled severe asthma despite maximal and optimal therapy , GINA stage IV
- Reversible airway obstruction ( a change of 12% of FEV1 after bronchodilator inhalation)
- Non smoking or smoking less then 10 PY.
- Positive skin test or RAST test for relevant allergen
- IGE blood level between 30-700 IU and
- Two or more asthma exacerbation needed systemic steroids treatment during the last twelve months or continuing systemic steroid treatment. or
- Contraindication to systemic steroid treatment due to side effects, such as osteoporosis and uncontrolled diabetes.
Exclusion
- Pregnancy or nursing mothers
- Subject who have experienced a severe hypersensitivity reaction to Xolair®
Key Trial Info
Start Date :
December 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01002976
Start Date
December 1 2009
End Date
December 1 2012
Last Update
January 24 2012
Active Locations (1)
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1
Carmel Medical Center
Haifa, Israel