Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)

NCT03028350 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CPI-IFE-006
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Asthma, Aspirin-Induced

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Sinonasal Outcome Test-22 Score

  Sinonasal Outcome Test-22 (SNOT-22) score is a scale with a minimum score of 0 and a maximum score of 110 based on the presence and severity of symptoms and outcomes of rhinosinusitis. Higher scores indicate worse symptoms and/or outcomes.

  Baseline and 8 weeks

Secondary Outcomes (6)

• Change From Baseline in Asthma Control Questionnaire -7 Score

  Baseline and 8 weeks

• Change From Baseline in Total Nasal Symptom Score (Morning)

  Baseline and 8 weeks

• Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)

  Baseline and 8 weeks

• Change From Baseline in Peak Nasal Inspiratory Flow Rate (PNIFR)

  Baseline and 8 weeks

• Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)

  Baseline and 8 weeks

Other Outcomes (1)

• Change From Baseline in Blood Eosinophil Count

  Baseline and 8 weeks

Study Arms (2)

Ifetroban Oral Capsule

EXPERIMENTAL

Oral ifetroban, 200 mg daily for 8 weeks

Drug: Ifetroban Oral Capsule

Placebo Oral Capsule

PLACEBO COMPARATOR

Oral placebo daily for 8 weeks

Drug: Placebo Oral Capsule

Interventions

Ifetroban Oral Capsule DRUG

Subjects will be treated with oral ifetroban daily for 8 weeks

Also known as: Ifetroban

Ifetroban Oral Capsule

Placebo Oral Capsule DRUG

Subjects will be treated with oral placebo daily for 8 weeks

Also known as: Placebo

Placebo Oral Capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (16)

Banner University of Arizona Medical Center, Asthma & Airway Disease Research Center

Tucson, Arizona, 85724, United States

Location

Antelope Valley Clinical Trials

Lancaster, California, 93534, United States

Location

Scripps Clinic - Carmel Valley

San Diego, California, 92130, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

The Research Center

Hialeah, Florida, 33013, United States

Location

Emory University School of Medicine, Sinus, Nasal, and Allergy Center

Atlanta, Georgia, 30308, United States

Location

Deaconess Clinic

Evansville, Indiana, 47713, United States

Location

Kansas City Allergy and Asthma Associates, PA

Overland Park, Kansas, 66210, United States

Location

Advanced ENT & Allergy

Louisville, Kentucky, 40207, United States

Location

Rochester Regional Health

Rochester, New York, 14607, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390-9035, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Asthma, Aspirin-Induced

Interventions

ifetroban

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Limitations and Caveats

Planned enrollment for the study was 76 subjects with 38 subjects per treatment arm. Due to enrollment challenges during and following the COVID-19 pandemic, the study was closed with 56 subjects enrolled.

Results Point of Contact

• Title: Senior Clinical Scientist
• Organization: Cumberland Pharmaceuticals

bgibson@cumberlandpharma.com

6154257644

Study Officials

• Andrew White, MD

  Scripps Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 23, 2017
• Study Start: July 17, 2017
• Primary Completion: April 25, 2023
• Study Completion: April 25, 2023
• Last Updated: July 10, 2024
• Results First Posted: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)