Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Aspirin; Ifetroban

Criteria

Inclusion Criteria:

1. 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.

2. 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)

3. Age between 18 and 70 years

4. No current smoking (not more than one instance of smoking in the last 3 months)

5. Non-pregnant

Exclusion Criteria:

1. Hypersensitivity to montelukast

2. Current use of zileuton

3. History of bleeding diathesis or use of anticoagulant or antiplatelet drugs

4. Current use of any NSAIDs aside from the aspirin provided during the study

5. Current use of beta blockers

6. Use of any biologics within the last 4 months prior to initiating the study