Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban

NCT ID: NCT03326063

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-26
• Study Completion Date: 2023-04-15

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 (AERD).

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 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ifetroban

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

Group Type: ACTIVE_COMPARATOR

Ifetroban

Intervention Type: DRUG

4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD

Placebo

Subjects will be randomized to receive placebo for 4 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD

Interventions

Ifetroban

4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD

Intervention Type: DRUG

Placebo

4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD

Intervention Type: DRUG

Other Intervention Names

ifetroban sodium

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elliot Israel, MD

Director of Asthma Research Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elliot Israel, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Asthma Research Center, Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017P001523

Identifier Type: -

Identifier Source: org_study_id