Status:
UNKNOWN
Effect of Xolair on Airway Hyperresponsiveness
Lead Sponsor:
Creighton University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Allergic Asthma
Eligibility:
All Genders
19-50 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if Xolair can reduce the abnormal increase in limitation to airflow in patients with asthma in a relatively short time period. Another purpose is to determine...
Detailed Description
Xolair, a recombinant humanized monoclonal anti-IgE antibody, has been studied extensively and proven efficacious in the treatment of asthma and other allergic disorders. In moderate to severe allergi...
Eligibility Criteria
Inclusion
- Female patients must have a negative urine pregnancy test at Visit 1 and a negative urine pregnancy test at subsequent visits. In addition, female patients must be using a medically acceptable form of birth control.
- History of mild to moderate asthma
- A positive skin prick test to one or more perennial environmental allergens (dog, cat, dermatophagoides farinae, or dermatophagoides pteronyssinus)
- A PC20 value for methacholine \< 5 mg/mL
- A PC15 value for hypertonic saline at \< 4 minutes
- Capable of faithfully attending regularly scheduled study visits
- Willing to avoid prohibited medications for the periods indicated in the protocol
- A baseline serum IgE level of \> 30 IU/mL and \< 700 IU/mL
Exclusion
- Women of childbearing potential not using a medically acceptable form of birth control, as well as women who are breastfeeding
- Known sensitivity to study drug or class of study drug
- Any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 2 weeks prior to the screening visit, or for which antibiotic therapy has not been completed at least 2 weeks prior to the screening visit
- Patients with a history of severe anaphylactoid or anaphylactic reactions
- Patients taking beta-adrenergic antagonists in any form
- Patients previously exposed to Xolair
- Patients with a known hypersensitivity to trial drug excipient ingredients or related drugs
- Chronic or intermittent use of inhaled, oral, intranasal, intramuscular, or intravenous corticosteroids, or use of topical corticosteroids other than intermittent use of low potency preparations
- Use of immunosuppressive medications
- History or presence of significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical condition, including autoimmune or collagen vascular disorders aside from organ-specific autoimmune disease limited to the thyroid that in the investigator's opinion could interfere with the study or require medical treatment that would interfere with the study
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00208234
Start Date
January 1 2004
End Date
September 1 2011
Last Update
September 23 2011
Active Locations (1)
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1
Creighton University Division of Allergy & Immunology
Omaha, Nebraska, United States, 68131