NCT02216357

Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Cumberland Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to determine the safety of oral ifetroban compared to placebo as measured by a \> 20% decrease in FEV1 compared to baseline following a dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) prior to initiation of the aspirin challenge.

Conditions

• Aspirin Exacerbated Respiratory Disease (AERD)

Interventions

Type	Name	Description
DRUG	Ifetroban, Oral Capsule
DRUG	Placebo, Oral Capsule

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-08-13
• Last updated: 2017-05-15
• Results posted: 2017-03-22

Locations

3 sites across 1 country: United States