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Sponsors and Collaborators: |
The Cleveland Clinic Genentech |
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Information provided by: | The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT00555971 |
This is a 24 week double-blind study consisting of up to 11 office visits for people 18 years of age with aspirin exacerbated respiratory disease (AERD). 21 subjects will participate and will be randomized 2:1 to receive Xolair (Omalizumab) or placebo. 14 subjects will receive Xolair and 7 will receive placebo. Xolair is a FDA approved medication for the treatment of moderate to severe allergic asthma. Injections will occur every 2-4 weeks, for 16 weeks. The dosage will be based upon IgE and body weight. Aspirin desensitization will occur 1-3 weeks later. One month after desensitization, the final visit will occur in the GCRC.
Properly selected patients with aspirin exacerbated respiratory disease (AERD) experience benefit in the course of their disease with aspirin desensitization treatment; however, AERD patients are at risk for potentially serious asthmatic reaction when undergoing aspirin desensitization. For this reason, this procedure is currently performed in a monitored setting. We hypothesize that administration of Xolair, a monoclonal anti-IgE antibody, prior to the aspirin desensitization will reduce severity of aspirin-induced respiratory reaction, and that ultimately, use of Xolair will permit this procedure to be performed safely in outpatient settings. This protocol also entails obtaining blood and urine samples to assess the influence of Xolair, compared with placebo. As aspirin induced reaction occurs via heightened release of leukotrienes combined with greater end organ responsiveness to these mediators, we also will be quantifying the impact of prior administration of Xolair, compared with placebo, on the elevation of urinary LTE4 in association with aspirin challenge and with aspirin provoked reaction.
Condition | Intervention | Phase |
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Aspirin Sensitive Rhinosinusitis/Asthma |
Drug: omalizumab |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Placebo Controlled, Double-Blind Investigation of the Therapeutic Utility of Xolair (Omalizumab) for Attenuating Aspirin Induced Bronchospasm in Patients With Aspirin Exacerbated Respiratory Disease (AERD) Undergoing Aspirin Desentization |
Estimated Enrollment: | 21 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | July 2008 |
Arms | Assigned Interventions |
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1: Placebo Comparator
Study drug versus placebo
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Drug: omalizumab
Dosage (150 - 375 mg) based on IgE levels; administered subcutaneously every 2-4 weeks for 16 weeks.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Contact: Dottie Vasas, RN | 216/445-4847 | vasasd@ccf.org |
United States, Ohio | |
The Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Dottie Vasas, R.N. 216-445-4847 vasasd@ccf.org | |
Principal Investigator: David M Lang, M.D. |
Principal Investigator: | David M. Lang, M.D. | The Cleveland Clinic, Department of Allergy and Immunology |
Study ID Numbers: | IRB 05-066, Q3637s |
Study First Received: | November 7, 2007 |
Last Updated: | November 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00555971 |
Health Authority: | United States: Food and Drug Administration |
Bronchial Spasm Aspirin Respiration Disorders Asthma Omalizumab |
Respiratory System Agents Therapeutic Uses Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions |