Clinical Trial: Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Phase 2 Multicenter, Double-blind, Randomized, Placebo-Controlled Trial to Evaluate Oral Ifetroban in Subjects With Symptomatic Aspirin Exacerbated Respiratory Disease (AERD)
Brief 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 Summary: 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.
Sponsor: Cumberland Pharmaceuticals
Current Primary Outcome: Change From Baseline in Sino-Nasal Outcome Test-22 score [ Time Frame: 8 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change From Baseline in Asthma Control Questionnaire -7 score [ Time Frame: 8 weeks ]
- Change From Baseline in Total Nasal Symptom score [ Time Frame: 8 weeks ]
- Change From Baseline in FEV1 [ Time Frame: 8 weeks ]
- Change From Baseline in PNIFR [ Time Frame: 8 weeks ]
- Change From Baseline in FeNO [ Time Frame: 8 weeks ]
- Change From Baseline in rescue medication [ Time Frame: 8 weeks ]
- Change From Baseline in antibiotic use [ Time Frame: 8 weeks ]
Original Secondary Outcome: Same as current
Information By: Cumberland Pharmaceuticals
Dates:
Date Received: January 19, 2017
Date Started: May 1, 2017
Date Completion: December 2018
Last Updated: January 19, 2017
Last Verified: January 2017
