NCT03326063

Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban

Therapeutic Control of Aspirin-Exacerbated Respiratory Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2018-04-26
• Primary completion: 2022-03-30
• Completion: 2023-04-15
• First posted: 2017-10-30
• Last updated: 2023-07-14
• Results posted: 2023-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study