Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization (NCT00555971) | Clinical Trial Compass
CompletedPhase 4
Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization
United States16 participantsStarted 2006-05
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 cardiovascu…
What they're measuring
1
Number of Participants Without Respiratory Reaction During Aspirin Desensitization