Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)

Asthma, Aspirin-Induced Clinical Trial

Official title:

A Phase 2 Multicenter, Double-blind, Randomized, Placebo-Controlled Trial to Evaluate Oral Ifetroban in Subjects With Symptomatic Aspirin Exacerbated Respiratory Disease (AERD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03028350
• Other study ID #: CPI-IFE-006
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 17, 2017
• Est. completion date: August 2024

Study information

• Verified date: August 2023
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: August 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma, Aspirin-Induced
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Drug:
• Ifetroban Oral Capsule
Subjects will be treated with oral ifetroban daily for 8 weeks
• Placebo Oral Capsule
Subjects will be treated with oral placebo daily for 8 weeks

Locations

Country	Name	City	State
United States	Emory University School of Medicine, Sinus, Nasal, and Allergy Center	Atlanta	Georgia
United States	Montefiore Medical Center	Bronx	New York
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Deaconess Clinic	Evansville	Indiana
United States	The Research Center	Hialeah	Florida
United States	Antelope Valley Clinical Trials	Lancaster	California
United States	Advanced ENT & Allergy	Louisville	Kentucky
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Kansas City Allergy and Asthma Associates, PA	Overland Park	Kansas
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Rochester Regional Health	Rochester	New York
United States	Scripps Clinic - Carmel Valley	San Diego	California
United States	Stanford University Medical Center	Stanford	California
United States	Banner University of Arizona Medical Center, Asthma & Airway Disease Research Center	Tucson	Arizona
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in blood, urine and nasal epithelial biomarkers		8 weeks
Primary	Change From Baseline in Sino-Nasal Outcome Test-22 score		8 weeks
Secondary	Change From Baseline in Asthma Control Questionnaire -7 score		8 weeks
Secondary	Change From Baseline in Total Nasal Symptom score		8 weeks
Secondary	Change From Baseline in FEV1		8 weeks
Secondary	Change From Baseline in PNIFR		8 weeks
Secondary	Change From Baseline in FeNO		8 weeks
Secondary	Change From Baseline in rescue medication		8 weeks
Secondary	Change From Baseline in antibiotic use		8 weeks