drugset / Trial / NCT02216357

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

NCT02216357 ↗

Phase 2 Completed 19 enrolled Cumberland Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2014-08
Primary completion
2016-01
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ifetroban Small molecule 200 mg Oral