Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
David Lang, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier:
NCT00555971
First received: November 7, 2007
Last updated: February 29, 2016
Last verified: February 2016
  Purpose

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 Intervention Phase
Aspirin Sensitivity
Drug: Omalizumab
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in markers of inflammation in association with aspirin challenge/desensitization [ Time Frame: Approximately 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: May 2006
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind.
Drug: placebo
aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis
Active Comparator: Omalizumab
Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind.
Drug: Omalizumab
aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis
Other Name: Xolair

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.

  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. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555971

Locations
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
David Lang
Genentech, Inc.
Investigators
Principal Investigator: David M. Lang, M.D. The Cleveland Clinic, Department of Allergy and Immunology
  More Information

Responsible Party: David Lang, Chairman, Allergy and Immunology, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT00555971     History of Changes
Other Study ID Numbers: IRB 05-066  Q3637s 
Study First Received: November 7, 2007
Last Updated: February 29, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Aspirin
Omalizumab
Analgesics
Analgesics, Non-Narcotic
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Respiratory System Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016