Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization
Completed · Phase 4 · Has a placebo group
Conditions studied: Aspirin Sensitivity
In brief
This is a 24 week double-blind study in which subjects will be randomized 2:1 to receive Xolair (Omalizumab) or placebo. 14 subjects will receive Xolair and 7 will receive placebo. Xolair injections will occur every 2-4 weeks. Aspirin desensitization will occur several weeks later. One month after desensitization, the final visit will occur in the GCRC. We hypothesize that administration of Xolair, a monoclonal anti-IgE antibody, prior to the aspirin desensitization will reduce severity of aspirin-induced reaction.
Key facts
- Study ID
- NCT00555971
- Run by
- David Lang
- People needed
- 16
- Starts
- 2006-05-01
- Expected to finish
- 2016-02-01
- Last updated by the study team
- 2020-11-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age > 18 years.
- Fulfill diagnostic criteria for AERD (described below), and be a candidate for aspirin desensitization chronic asthma - frequently moderate-severe or severe patients will have history compatible with variable airflow obstruction. chronic rhinosinusitis - usually requiring previous sinus surgery procedure(s). sinusitis will have been confirmed by imaging studies presently and/or in the past.
- history of adverse reaction to aspirin and/or aspirin-like drugs (e.g., ibuprofen, naproxen, etc.) compatible with AERD.
- Candidate for Xolair [Omalizumab] Moderate-severe persistent asthma IgE = 30-700 IU/ml IgE mediated (allergic) potential to inhalant allergen(s) by cutaneous or in vitro testing.
You may not qualify if…
- Women of childbearing potential not using appropriate contraception method(s)
- Women currently breastfeeding
- Women who desire to become pregnant during the time of participation in this study
- Men who desire to get someone pregnant during participation in this study
- Known sensitivity to Xolair [Omalizumab].
- IgE level < 30 IU/ml, or > 700 IU/ml.
- No evidence of atopy by immediate hypersensitivity skin testing
- Use of any other investigational agent in the last 30 days
- Age < 18 years.
- Current tobacco habituation.
- Presence of emphysema
- Ethanolism or drug abuse within last 12 months.
- Presence of significant medical condition including malignancy, neurologic, kidney, gastrointestinal, liver or cardiovascular disease
- extensive travel commitments during the study that would interfere with study measurements or clinic visits.
Where it is running
- The Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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