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Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00555971
Recruitment Status : Completed
First Posted : November 9, 2007
Results First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
David Lang, The Cleveland Clinic

Brief 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.


Condition or disease Intervention/treatment Phase
Aspirin Sensitivity Drug: Omalizumab Drug: placebo Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : May 2006
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Group
Subjects randomized to placebo
Drug: placebo
Subjects randomized to Placebo prior to aspirin desensitization

Active Comparator: Omalizumab Group
Subjects randomized to omalizumab
Drug: Omalizumab
Subjects randomized to Omalizumab prior to aspirin desensitization
Other Name: Xolair




Primary Outcome Measures :
  1. Number of Participants Without Respiratory Reaction During Aspirin Desensitization [ Time Frame: 24 weeks ]
    Lack of Respiratory reaction during aspirin desensitization, including Spirometry (FEV1) testing, to assess the efficacy of Xolair on attenuating aspirin induced bronchospasm in patients with AERD.


Secondary Outcome Measures :
  1. Measurements of Urinary LTE4 in Association With Respiratory Reaction During Aspirin Desensitization [ Time Frame: Approximately 24 weeks ]
    Measurements of urinary LTE4 in association with aspirin desensitization, comparing subjects randomized to placebo with subjects randomized to omalizumab, with study drug administered for 16 weeks. Measurements were compared for respiratory reaction in placebo subjects who exhibited either upper or lower airway reaction and after 100 mg aspirin challenge dose in omalizumab subjects who were non-reactors.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555971


Locations
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United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
David Lang
Genentech, Inc.
Investigators
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Principal Investigator: David M. Lang, M.D. The Cleveland Clinic, Department of Allergy and Immunology
  Study Documents (Full-Text)

Documents provided by David Lang, The Cleveland Clinic:
Study Protocol  [PDF] January 16, 2013

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Lang, Chairman, Allergy and Immunology, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00555971    
Other Study ID Numbers: IRB 05-066
Q3637s ( Other Grant/Funding Number: Genentech )
First Posted: November 9, 2007    Key Record Dates
Results First Posted: March 26, 2019
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents