Conditions: Aspirin Exacerbated Respiratory Disease (AERD)
Keywords: Samster's triad Acetylsalicylic acid triad Widal's triad Francis' triad Aspirin triad Aspirin-induced asthma and rhinitis (AIAR)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 19
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3. arm 2: Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.

Interventions: intervention 1: Ifetroban, Oral Capsule intervention 2: Placebo, Oral Capsule
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: