NCT03028350

Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)

A Phase 2 Multicenter, Double-blind, Randomized, Placebo-Controlled Trial to Evaluate Oral Ifetroban in Subjects With Symptomatic Aspirin Exacerbated Respiratory Disease (AERD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Cumberland Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs.

Detailed description

This is a randomized, placebo-controlled, double-blind phase 2 trial evaluating approximately 76 subjects with symptomatic AERD on the safety and efficacy of 8 weeks of oral ifetroban treatment. Eligible AERD subjects will be randomized to receive 8 weeks of either oral ifetroban daily or matching placebo followed by a 2-week post-treatment period.

Conditions

• Asthma, Aspirin-Induced

Interventions

Type	Name	Description
DRUG	Ifetroban Oral Capsule	Subjects will be treated with oral ifetroban daily for 8 weeks
DRUG	Placebo Oral Capsule	Subjects will be treated with oral placebo daily for 8 weeks

Timeline

• Start date: 2017-07-17
• Primary completion: 2023-04-25
• Completion: 2023-04-25
• First posted: 2017-01-23
• Last updated: 2024-07-10
• Results posted: 2024-06-28

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study