Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)

Purpose

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.

Condition

  • Asthma, Aspirin-Induced

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. History of physician-diagnosed asthma
  2. History of nasal polyposis
  3. 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.
  4. 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).
  5. ≥ 18 years of age
  6. 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

  1. 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.
  2. Current pregnancy or breastfeeding
  3. Use of oral or systemic steroids (e.g. prednisone or equivalent) > 20 mg daily in the last four weeks before starting treatment.
  4. Daily use of long-acting antihistamines in the last two weeks before starting treatment.
  5. 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).
  6. Any use of nonsteroidal anti-inflammatory drugs (NSAIDs) or any drug that inhibits the cyclooxygenase enzyme in the last two weeks before starting treatment.
  7. History of bleeding diathesis or use of anticoagulant or antiplatelet drugs in the last two weeks before starting treatment.
  8. 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.
  9. Endoscopic sinus surgery / polypectomy within the past three months
  10. Previously treated in a clinical trial with ifetroban within the past three months.
  11. Previously treated with other investigational drugs within eight weeks or five half-lives, whichever is longer, before screening
  12. Conditions/concomitant disease which make them unevaluable for the efficacy endpoints

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ifetroban Oral Capsule
Oral ifetroban, 200 mg daily for 8 weeks
  • Drug: Ifetroban Oral Capsule
    Subjects will be treated with oral ifetroban daily for 8 weeks
    Other names:
    • Ifetroban
Placebo Comparator
Placebo Oral Capsule
Oral placebo daily for 8 weeks
  • Drug: Placebo Oral Capsule
    Subjects will be treated with oral placebo daily for 8 weeks
    Other names:
    • Placebo

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Cindy Dorminy, MEd, LPN
615-936-8384

More Details

NCT ID
NCT03028350
Status
Recruiting
Sponsor
Cumberland Pharmaceuticals

Study Contact

Byron Kaelin, RN, BSHS
615-255-0068
bkaelin@cumberlandpharma.com

Detailed 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.