Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization

NCT ID: NCT00555971

Last Updated: 2020-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2016-02-29

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.

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.

Conditions

Aspirin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Group

Subjects randomized to placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Subjects randomized to Placebo prior to aspirin desensitization

Omalizumab Group

Subjects randomized to omalizumab

Group Type: ACTIVE_COMPARATOR

Omalizumab

Intervention Type: DRUG

Subjects randomized to Omalizumab prior to aspirin desensitization

Interventions

Omalizumab

Subjects randomized to Omalizumab prior to aspirin desensitization

Intervention Type: DRUG

placebo

Subjects randomized to Placebo prior to aspirin desensitization

Intervention Type: DRUG

Other Intervention Names

Xolair

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

David Lang

OTHER

Sponsor Role: lead

Responsible Party

David Lang

Chairman, Allergy and Immunology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David M. Lang, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic, Department of Allergy and Immunology

Locations

The Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

Lang DM, Aronica MA, Maierson ES, Wang XF, Vasas DC, Hazen SL. Omalizumab can inhibit respiratory reaction during aspirin desensitization. Ann Allergy Asthma Immunol. 2018 Jul;121(1):98-104. doi: 10.1016/j.anai.2018.05.007. Epub 2018 May 16.

Reference Type: DERIVED

PMID: 29777744 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

Q3637s

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB 05-066

Identifier Type: -

Identifier Source: org_study_id