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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
19
Scripps Clinic
San Diego, California, United States
Kansas City Allergy and Asthma Associates, PA.
Overland Park, Kansas, United States
Allergy & Asthma Consultants of Rockland & Bergen
West Nyack, New York, United States
Proportion of Patients Who Experience a ≥ 20% Decrease in Forced Expiratory Volume in One Second (FEV1) Compared to Baseline Following a Dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge
Time frame: Study Day 2
Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge
Time frame: Up to Study Day 2
Proportion of Patients With a ≥ 25% Increase in Total Nasal Symptom Score (TNSS) Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge
Time frame: Up to Study Day 2
Incidence and Severity of Treatment-emergent Adverse Events
Time frame: Up to Study Day 7
Proportion of Patients Who Experience a ≥ 20% Decrease in FEV1 Compared to Baseline During the Aspirin Challenge
Time frame: Study Day 2 and 3
Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate (NIFR) Compared to Baseline During the Aspirin Challenge
Time frame: Study Day 2 and 3
Proportion of Patients With a ≥ 25% Increase in TNSS Compared to Baseline During the Aspirin Challenge
Time frame: Study Day 2 and 3
Amount of Rescue Medication Required During the Aspirin Challenge
The amount of rescue medication required during the aspirin challenge
Time frame: Study Day 2 and 3
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Incidence and Severity of Asthmatic Reactions During the Treatment Period
Time frame: Study Day 1 through 3
Proportion of Patients With an Aspirin Desensitization Dose Level of 30 mg, 60 mg, 100 mg, 150 mg, and 325 mg.
Time frame: Study Day 2 and 3