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.
Provided treatments
Drug: Ifetroban Oral Capsule
Drug: Placebo Oral Capsule
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Locations near you
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Full eligibility criteria for NCT03028350
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
History of physician-diagnosed asthma
History of nasal polyposis
History of at least two reactions to oral aspirin or other nonselective cyclooxygenase inhibitor with features of lower airway involvement (cough, chest tightness, wheezing, dyspnea), or one reaction that was life-threatening and required hospitalization, or a diagnosis of AERD by a physician-conducted challenge to aspirin in the last five years before starting treatment.
Stable asthma (post-bronchodilator FEV1 of ≥ 60%, no glucocorticoid burst for at least two weeks prior to starting treatment, no hospitalizations or emergency room visits for asthma at least three months prior to starting treatment and not on a dose >1000 µg fluticasone or equivalent daily).
≥ 18 years of age
Exhibit symptomatic AERD within three weeks of starting treatment by demonstrating a score of at least 20 on the Sino-nasal Outcome Test (SNOT) - 22.
Exclusion Criteria:
Current smoking, defined as daily tobacco smoking in the last six months and at least one instance of tobacco smoking in the last three months.
Current pregnancy or breastfeeding
Use of oral or systemic steroids (e.g. prednisone or equivalent) > 20 mg daily in the last four weeks before starting treatment.
Daily use of long-acting antihistamines in the last two weeks before starting treatment.
Less than 12 months of allergy shots (maintenance dose of allergy shots are allowed if treatment duration exceeds 12 months). Less than 1 month of 5-lipoxygenase inhibitors
(e.g. zileuton) and/or leukotriene receptor antagonists (e.g. montelukast).
Any use of nonsteroidal anti-inflammatory drugs (NSAIDs) or any drug that inhibits the cyclooxygenase enzyme in the last two weeks before starting treatment.
History of bleeding diathesis or use of anticoagulant or antiplatelet drugs in the last two weeks before starting treatment.
Any immunosuppressive treatment including but not limited to methotrexate, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine, hydroxychloroquine, azathioprine, and cyclophosphamide in the last two weeks before starting treatment (maintenance dose of allergy shots are allowed if treatment duration exceeds 12 months). Biologics/immunotherapies such as Xolair or Nucala are permitted if duration exceeds three months.
Endoscopic sinus surgery / polypectomy within the past three months
Previously treated in a clinical trial with ifetroban within the past three months.
Previously treated with other investigational drugs within eight weeks or five half-lives, whichever is longer, before screening
Conditions/concomitant disease which make them unevaluable for the efficacy endpoints
All locations for NCT03028350
10 locations
United States (10)
Scripps Clinic - Carmel Valley
San Diego, California, United States, 92130
recruiting
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Stanford University Medical Center
Stanford, California, United States, 94305
recruiting
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The Research Center
Hialeah, Florida, United States, 33013
recruiting
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Kansas City Allergy and Asthma Associates, PA
Overland Park, Kansas, United States, 66210
recruiting
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Montefiore Medical Center
Bronx, New York, United States, 10461
recruiting
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Clinical Research Trials , LLC
Canton, Ohio, United States, 44718
recruiting
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University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
recruiting
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Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
recruiting
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UT Southwestern Medical Center
Dallas, Texas, United States, 75390-9035
recruiting
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University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
recruiting
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All Locations
View full eligibility
Results
Tris trial is registered with FDA with number: NCT03028350. The sponsor of the trial is Cumberland Pharmaceuticals and it is looking for 76 volunteers for the current phase.
Official trial title: A Phase 2 Multicenter, Double-blind, Randomized, Placebo-Controlled Trial to Evaluate Oral Ifetroban in Subjects With Symptomatic Aspirin Exacerbated Respiratory Disease (AERD)
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