Status:
COMPLETED
Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Nasal Polyps
Asthma, Aspirin-Induced
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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...
Detailed 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 sub...
Eligibility Criteria
Inclusion
- 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 cyclooxygenase (COX) inhibitors.
- Stable asthma (post-bronchodilator forced expiratory volume at one second (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
- 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
Key Trial Info
Start Date :
April 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2023
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03326063
Start Date
April 26 2018
End Date
April 15 2023
Last Update
July 14 2023
Active Locations (1)
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1
Asthma Research Center, Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115