Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Aspirin-exacerbated Respiratory Disease; Nasal Polyps; Asthma, Aspirin-Induced; Aspirin-Sensitive Asthma With Nasal Polyps

Treatments: Drug: Placebo; Drug: Ifetroban

Study type: Interventional

Funder types: Other

Identifiers

NCT03326063

2017P001523

Details and patient eligibility

About

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).

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 cyclooxygenase (COX) inhibitors.

2. 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)

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 2 patient groups, including a placebo group

Ifetroban

Active Comparator group

Description:

Subjects will be randomized to receive ifetroban (200 mg dose per day) for 4 weeks.

Treatment:

Drug: Ifetroban

Placebo

Placebo Comparator group

Description:

Subjects will be randomized to receive placebo for 4 weeks.

Treatment:

Drug: Placebo