Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02216357
Recruitment Status : Completed
First Posted : August 13, 2014
Results First Posted : March 22, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

Brief Summary:
The primary objective of the study is to determine the safety of oral ifetroban compared to placebo as measured by a > 20% decrease in FEV1 compared to baseline following a dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) prior to initiation of the aspirin challenge.

Condition or disease Intervention/treatment Phase
Aspirin Exacerbated Respiratory Disease (AERD) Drug: Ifetroban, Oral Capsule Drug: Placebo, Oral Capsule Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease
Study Start Date : August 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: Ifetroban, Oral Capsule
Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Drug: Ifetroban, Oral Capsule
Placebo Comparator: Placebo, Oral Capsule
Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Drug: Placebo, Oral Capsule



Primary Outcome Measures :
  1. Proportion of Patients Who Experience a ≥ 20% Decrease in Forced Expiratory Volume in One Second (FEV1) Compared to Baseline Following a Dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge [ Time Frame: Study Day 2 ]

Secondary Outcome Measures :
  1. Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge [ Time Frame: Up to Study Day 2 ]
  2. Proportion of Patients With a ≥ 25% Increase in Total Nasal Symptom Score (TNSS) Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge [ Time Frame: Up to Study Day 2 ]
  3. Incidence and Severity of Treatment-emergent Adverse Events [ Time Frame: Up to Study Day 7 ]
  4. Proportion of Patients Who Experience a ≥ 20% Decrease in FEV1 Compared to Baseline During the Aspirin Challenge [ Time Frame: Study Day 2 and 3 ]
  5. Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate (NIFR) Compared to Baseline During the Aspirin Challenge [ Time Frame: Study Day 2 and 3 ]
  6. Proportion of Patients With a ≥ 25% Increase in TNSS Compared to Baseline During the Aspirin Challenge [ Time Frame: Study Day 2 and 3 ]
  7. Amount of Rescue Medication Required During the Aspirin Challenge [ Time Frame: Study Day 2 and 3 ]
    The amount of rescue medication required during the aspirin challenge

  8. Incidence and Severity of Asthmatic Reactions During the Treatment Period [ Time Frame: Study Day 1 through 3 ]
  9. Proportion of Patients With an Aspirin Desensitization Dose Level of 30 mg, 60 mg, 100 mg, 150 mg, and 325 mg. [ Time Frame: Study Day 2 and 3 ]


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults with a history of physician-diagnosed stable asthma (FEV1 of at least 1.25 liters and 60% or better than predicted* on two previous visits with no more than a 10% variation in those values, no increase in baseline dose of oral glucocorticoids for asthma for at least three months, and no history of hospitalization or emergency room visits for asthma for at least the prior six months).
  2. Have a history of nasal polyposis.
  3. Have a history of at least one clinical reaction to oral aspirin or other nonselective cyclooxygenase (COX) inhibitor with features of lower (cough, chest tightness, wheezing, dyspnea) and/or upper (rhinorrhea, sneezing, nasal obstruction, conjunctival itching and discharge) airway involvement.
  4. Currently receiving montelukast (at least 10 mg per day, oral) or Zafirlukast (at least 20 mg twice per day, oral), with at least 1 week of therapy prior to first dose of IMP.

Exclusion Criteria:

  1. Be less than 18 years of age or greater than or equal to 65 years of age.
  2. Be pregnant, nursing, or planning to become pregnant.
  3. Be a current tobacco smoker (defined as a daily tobacco smoker during any of the six months preceding this study or more than one instance of tobacco smoking in the last three months).
  4. Use of a beta blocker in the last week.
  5. Use of an antihistamine in the 48 hours prior to the first dose of IMP.
  6. Use of nasal decongestants in the 48 hours prior to the first dose of IMP.
  7. Use of aspirin or non-steroidal inflammatory drug (NSAID) in the last two weeks.
  8. Use of zileuton in the last two weeks.
  9. Have required one or more doses of ≥ 40 mg prednisone or equivalent in the last two weeks.
  10. Have a history of systemic or life-threatening respiratory reaction to aspirin requiring intubation or administration of epinephrine.
  11. Have a history of peptic ulcer disease, gastrointestinal bleed, or current severe gastro-esophageal reflux disease (GERD), defined as a patient currently requiring more than two total doses of medication per day to treat persistent symptoms: either more than two doses of any single medication type (antacid, proton pump inhibitor, or H2 receptor antagonist), or more than 2 types of medication per day to treat symptoms.
  12. Have a history of tolerating a COX-1 blocking drug after their history of a respiratory reaction to a similar drug.
  13. Have a history of cardiovascular disease including myocardial infarction, heart failure, atrial or ventricular rhythm disturbances, or angina, or a previous abnormal electrocardiogram.
  14. Have a history of bleeding diathesis or use of anticoagulant or antiplatelet drugs in the last two weeks.
  15. Have a history of allergy or hypersensitivity to ifetroban.
  16. Have taken investigational drugs within 30 days before IMP administration.
  17. Inability to understand the requirements of the study, inability to understand spoken English and abide by the study restrictions and to return for the required treatments and assessments.
  18. Be otherwise unsuitable for the study, in the opinion of the investigator.

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): NCT02216357


Locations
Layout table for location information
United States, California
Scripps Clinic
San Diego, California, United States, 32130
United States, Kansas
Kansas City Allergy and Asthma Associates, PA.
Overland Park, Kansas, United States, 66210
United States, New York
Allergy & Asthma Consultants of Rockland & Bergen
West Nyack, New York, United States, 10994
Sponsors and Collaborators
Cumberland Pharmaceuticals

Layout table for additonal information
Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02216357    
Other Study ID Numbers: CPI-IFE-003
First Posted: August 13, 2014    Key Record Dates
Results First Posted: March 22, 2017
Last Update Posted: May 15, 2017
Last Verified: April 2017
Keywords provided by Cumberland Pharmaceuticals:
Samster's triad
Acetylsalicylic acid triad
Widal's triad
Francis' triad
Aspirin triad
Aspirin-induced asthma and rhinitis (AIAR)
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiration Disorders
Respiratory Tract Diseases
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