Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated… (NCT02216357) | Clinical Trial Compass
CompletedPhase 2
Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease
United States19 participantsStarted 2014-08
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Adults with a history of physician-diagnosed stable asthma (FEV1 of at least 1.25 liters and 60% or better than predicted\* on two previous visits with no more than a 10% variation in those values, no increase in baseline dose of oral glucocorticoids for asthma for at least three months, and no history of hospitalization or emergency room visits for asthma for at least the prior six months).
✓. Have a history of nasal polyposis.
✓. Have a history of at least one clinical reaction to oral aspirin or other nonselective cyclooxygenase (COX) inhibitor with features of lower (cough, chest tightness, wheezing, dyspnea) and/or upper (rhinorrhea, sneezing, nasal obstruction, conjunctival itching and discharge) airway involvement.
✓. Currently receiving montelukast (at least 10 mg per day, oral) or Zafirlukast (at least 20 mg twice per day, oral), with at least 1 week of therapy prior to first dose of IMP.
Exclusion criteria
✕. Be less than 18 years of age or greater than or equal to 65 years of age.
✕. Be pregnant, nursing, or planning to become pregnant.
✕. Be a current tobacco smoker (defined as a daily tobacco smoker during any of the six months preceding this study or more than one instance of tobacco smoking in the last three months).
✕. Use of a beta blocker in the last week.
✕. Use of an antihistamine in the 48 hours prior to the first dose of IMP.
✕. Use of nasal decongestants in the 48 hours prior to the first dose of IMP.
What they're measuring
1
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