Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization

NCT00555971 | Completed Phase 4 Results

• 2 other identifiers: IRB 05-066Q3637s
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Aspirin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Number of Participants Without Respiratory Reaction During Aspirin Desensitization

  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.

  24 weeks

Secondary Outcomes (1)

• Measurements of Urinary LTE4 in Association With Respiratory Reaction During Aspirin Desensitization

  Approximately 24 weeks

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Subjects randomized to placebo

Drug: placebo

Omalizumab Group

ACTIVE COMPARATOR

Subjects randomized to omalizumab

Drug: Omalizumab

Interventions

Omalizumab DRUG

Subjects randomized to Omalizumab prior to aspirin desensitization

Also known as: Xolair

Omalizumab Group

placebo DRUG

Subjects randomized to Placebo prior to aspirin desensitization

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• David Lang: lead
• Genentech, Inc.: collaborator

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 29777744 DERIVED

MeSH Terms

Interventions

Omalizumab

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Limitations and Caveats

Findings cannot be generalized to patients with aspirin exacerbated respiratory disease receiving omalizumab for less than 16 weeks, or to those who do not fulfill label criteria for omalizumab.

Results Point of Contact

• Title: David M. Lang
• Organization: Cleveland Clinic

langd@ccf.org

216-444-6933

Study Officials

• David M. Lang, M.D.

  The Cleveland Clinic, Department of Allergy and Immunology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman, Allergy and Immunology

Study Record Dates

• First Submitted: November 7, 2007
• First Posted: November 9, 2007
• Study Start: May 1, 2006
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: November 3, 2020
• Results First Posted: March 26, 2019

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)