Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban

  • STATUS
    Recruiting
  • days left to enroll
    62
  • participants needed
    45
  • sponsor
    Brigham and Women's Hospital
Updated on 4 March 2022
aspirin
asthma
respiratory disease
other disease
polyposis
ifetroban

Summary

The overall aim of the study is to determine the efficacy of oral ifetroban, a novel antagonist of T prostanoid (TP) receptors, as a treatment for patients with aspirin-exacerbated respiratory disease (AERD).

Description

The protocol involves a 4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban in patients with AERD. At the end of the 4-week treatment phase (ifetroban or placebo) each subject will undergo a graded oral aspirin desensitization procedure in order to initiate high-dose aspirin therapy, which is standard-of-care at our institution and is the only available therapy known to modify the course of AERD.

Details
Condition Nasal Polyps, Asthma, Aspirin-Induced, Aspirin-exacerbated Respiratory Disease, Aspirin-Sensitive Asthma With Nasal Polyps
Treatment Placebo, Ifetroban
Clinical Study IdentifierNCT03326063
SponsorBrigham and Women's Hospital
Last Modified on4 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

History of AERD, defined as meeting the diagnostic triad with
History of physician-diagnosed asthma and
History of physician-diagnosed nasal polyposis and
History of pathognomonic reactions aspirin or other nonselective COX inhibitors
Stable asthma (post-bronchodilator FEV1 of 70%, no glucocorticoid burst for at least 2 weeks prior to Visit 1, and no hospitalizations or ER visits for asthma for at least the prior 6 months)
Age between 18 and 70 years
No current smoking (not more than one instance of smoking in the last 3 months)
Non-pregnant

Exclusion Criteria

Hypersensitivity to montelukast
Current use of zileuton
History of bleeding diathesis or use of anticoagulant or antiplatelet drugs
Current use of any NSAIDs aside from the aspirin provided during the study
Current use of beta blockers
Use of any biologics within the last 4 months prior to initiating the study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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