Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma, Aspirin-Induced

In brief

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.

Key facts

Study ID

NCT03028350

Run by

Cumberland Pharmaceuticals

People needed

54

Starts

2017-07-17

Expected to finish

2023-04-25

Last updated by the study team

2024-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 forced expiratory volume in 1 second (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.

You may not qualify if…

• 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

Where it is running

• Banner University of Arizona Medical Center, Asthma & Airway Disease Research Center — Tucson, Arizona, United States
• Antelope Valley Clinical Trials — Lancaster, California, United States
• 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
• Montefiore Medical Center — The Bronx, New York, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• University of Virginia Medical Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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