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Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization
This study is currently recruiting participants.
Verified by The Cleveland Clinic, November 2007
Sponsors and Collaborators: The Cleveland Clinic
Genentech
Information provided by: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00555971
  Purpose

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
Aspirin Sensitive Rhinosinusitis/Asthma
Drug: omalizumab
Phase IV

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab Acetylsalicylic acid
U.S. FDA Resources
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

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Spirometry (FEV1) testing to assess the efficacy of Xolair on aspirin induced bronchospasm during aspirin desensitization in patients with AERD. [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Changes in serum and urinary markers of eosinophil activation during desensitization and change in urinary LTE4 during bronchospasm. Assessment of aspirin dose that provokes reaction. [ Time Frame: Approximately 24 weeks ]

Estimated Enrollment: 21
Study Start Date: May 2006
Estimated Study Completion Date: July 2008
Arms Assigned Interventions
1: Placebo Comparator
Study drug versus placebo
Drug: omalizumab
Dosage (150 - 375 mg) based on IgE levels; administered subcutaneously every 2-4 weeks for 16 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. patients will have exhibited ≥ 12% increase in FEV1 following bronchodilator. 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 cardiovascular disease
  • extensive travel commitments during the study that would interfere with study measurements or clinic visits.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555971

Contacts
Contact: Dottie Vasas, RN 216/445-4847 vasasd@ccf.org

Locations
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.            
Sponsors and Collaborators
The Cleveland Clinic
Genentech
Investigators
Principal Investigator: David M. Lang, M.D. The Cleveland Clinic, Department of Allergy and Immunology
  More Information

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

Study placed in the following topic categories:
Bronchial Spasm
Aspirin
Respiration Disorders
Asthma
Omalizumab

Additional relevant MeSH terms:
Respiratory System Agents
Therapeutic Uses
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009