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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
Subjects will be treated with oral ifetroban daily for 8 weeks
Subjects will be treated with oral placebo daily for 8 weeks
Banner University of Arizona Medical Center, Asthma & Airway Disease Research Center
Tucson, Arizona, United States
Antelope Valley Clinical Trials
Lancaster, California, United States
Change From Baseline in Sinonasal Outcome Test-22 Score
Sinonasal Outcome Test-22 (SNOT-22) score is a scale with a minimum score of 0 and a maximum score of 110 based on the presence and severity of symptoms and outcomes of rhinosinusitis. Higher scores indicate worse symptoms and/or outcomes.
Time frame: Baseline and 8 weeks
Change From Baseline in Asthma Control Questionnaire -7 Score
The Asthma Control Questionnaire-7 is a scoring system with a minimum score of 0 and a maximum score of 6 based on the severity and frequency of asthma symptoms. Higher scores indicate worse control of asthma symptoms.
Time frame: Baseline and 8 weeks
Change From Baseline in Total Nasal Symptom Score (Morning)
The Total Nasal Symptom Score is a scoring system with a minimum score of 0 and maximum score of 15 based on severity of nasal symptoms. Higher scores indicate worse nasal symptoms.
Time frame: Baseline and 8 weeks
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Change From Baseline in Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Time frame: Baseline and 8 weeks
Change From Baseline in Peak Nasal Inspiratory Flow Rate (PNIFR)
Change From Baseline in Peak Nasal Inspiratory Flow Rate (PNIFR) at 8 weeks
Time frame: Baseline and 8 weeks
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at 8 weeks
Time frame: Baseline and 8 weeks
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Scripps Clinic - Carmel Valley
San Diego, California, United States
Stanford University Medical Center
Stanford, California, United States
The Research Center
Hialeah, Florida, United States
Emory University School of Medicine, Sinus, Nasal, and Allergy Center
Atlanta, Georgia, United States
Deaconess Clinic
Evansville, Indiana, United States
Kansas City Allergy and Asthma Associates, PA
Overland Park, Kansas, United States
Advanced ENT & Allergy
Louisville, Kentucky, United States
Rochester Regional Health
Rochester, New York, United States
...and 6 more locations
Change From Baseline in Total Nasal Symptom Score (Afternoon/Evening)
The Total Nasal Symptom Score is a scale with a minimum score of 0 and maximum score of 15 based on severity of nasal symptoms. Higher scores indicate worse nasal symptoms.
Time frame: Baseline and 8 weeks