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Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)

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ClinicalTrials.gov Identifier: NCT03028350
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Asthma, Aspirin-Induced Drug: Ifetroban Oral Capsule Drug: Placebo Oral Capsule Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : July 17, 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Aspirin

Arm Intervention/treatment
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 Name: 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 Name: Placebo




Primary Outcome Measures :
  1. Change From Baseline in Sino-Nasal Outcome Test-22 score [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change From Baseline in Asthma Control Questionnaire -7 score [ Time Frame: 8 weeks ]
  2. Change From Baseline in Total Nasal Symptom score [ Time Frame: 8 weeks ]
  3. Change From Baseline in FEV1 [ Time Frame: 8 weeks ]
  4. Change From Baseline in PNIFR [ Time Frame: 8 weeks ]
  5. Change From Baseline in FeNO [ Time Frame: 8 weeks ]
  6. Change From Baseline in rescue medication [ Time Frame: 8 weeks ]
  7. Change From Baseline in antibiotic use [ Time Frame: 8 weeks ]

Other Outcome Measures:
  1. Change From Baseline in blood, urine and nasal epithelial biomarkers [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028350


Contacts
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Contact: Byron Kaelin, RN, BSHS 615-255-0068 ext 250 bkaelin@cumberlandpharma.com
Contact: Ines Macias-Perez, PhD 615-979-5778 imaciasperez@cumberlandpharma.com

Locations
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United States, Arizona
Banner University of Arizona Medical Center, Asthma & Airway Disease Research Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Nirushan Narendran, MS    520-626-5554    nirushan@email.arizona.edu   
Principal Investigator: Tara Carr, MD         
United States, California
Scripps Clinic - Carmel Valley Recruiting
San Diego, California, United States, 92130
Contact: Anushree Singh    858-764-3023      
Principal Investigator: Andrew White, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Aakanksha Rathor, MD    408-872-2257      
Principal Investigator: Peter Hwang, MD         
United States, Florida
The Research Center Recruiting
Hialeah, Florida, United States, 33013
Contact: Laine Batista    305-603-8844      
Contact: Damian Beltran-Garces    (305) 603-8844      
United States, Georgia
Emory University School of Medicine, Sinus, Nasal, and Allergy Center Recruiting
Atlanta, Georgia, United States, 30308
Contact: Monica Battle, MSBR    404-686-3912    monica.battle@emory.edu   
Principal Investigator: Joshua Levy, MD         
United States, Indiana
Deaconess Clinic Recruiting
Evansville, Indiana, United States, 47713
Contact: Lindsay Bingham, RN    812-426-6636    Lindsay.Bingham@deaconess.com   
Contact: Tiffany Stewart    (=812-492-5019    tiffany.stewart@deaconess.com   
Principal Investigator: Majed Koleilat, MD         
United States, Kansas
Kansas City Allergy and Asthma Associates, PA Recruiting
Overland Park, Kansas, United States, 66210
Contact: James B Sterner, MD    913-338-1610      
Contact: Andrea Bennington, CCRC    913-338-1610      
United States, Kentucky
Advanced ENT & Allergy Recruiting
Louisville, Kentucky, United States, 40207
Contact: Jennifer Leonard, MA    502-893-0159 ext 1184    jleonard@advancedentandallergy.com   
Principal Investigator: Mark Corbett, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Mydalyn Beronilla, MPH    929-263-3262      
Principal Investigator: Elina Jerschow, MD         
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27104
Contact: Anna Pippins    336-713-9184    apippins@wakehealth.edu   
Principal Investigator: Wendy Moore, MD         
United States, Ohio
Clinical Research Trials , LLC Withdrawn
Canton, Ohio, United States, 44718
United States, Pennsylvania
University of Pennsylvania Withdrawn
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Cindy Dorminy, MEd, LPN    615-936-8384      
Principal Investigator: Rakesh Chandra, MD         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-9035
Contact: Mary Martin    214-648-3626      
Principal Investigator: David Khan, MD         
United States, Virginia
University of Virginia Medical Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: B.J. Ferrebee Ghamandi, MHA    434-243-1558      
Principal Investigator: Spencer Payne, MD         
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
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Principal Investigator: Andrew White, MD Scripps Research Institute

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Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03028350     History of Changes
Other Study ID Numbers: CPI-IFE-006
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Asthma, Aspirin-Induced
Asthma
Bronchial Diseases
Respiratory Hypersensitivity
Drug Hypersensitivity
Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Aspirin
Ifetroban
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics