Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)

  • STATUS
    Recruiting
  • End date
    Aug 15, 2024
  • participants needed
    76
  • sponsor
    Cumberland Pharmaceuticals
Updated on 15 May 2022

Summary

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.

Description

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.

Details
Condition Asthma, Aspirin-Induced
Treatment Placebo oral capsule, Ifetroban Oral Capsule
Clinical Study IdentifierNCT03028350
SponsorCumberland Pharmaceuticals
Last Modified on15 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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