Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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

Tracking Information
First Submitted Date  ICMJE August 12, 2014
First Posted Date  ICMJE August 13, 2014
Results First Submitted Date  ICMJE February 2, 2017
Results First Posted Date  ICMJE March 22, 2017
Last Update Posted Date May 15, 2017
Study Start Date  ICMJE August 2014
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 12, 2014)
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: Up to Study Day 2 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
  • 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 ]
  • 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 ]
  • Incidence and Severity of Treatment-emergent Adverse Events [ Time Frame: Up to Study Day 7 ]
  • Proportion of Patients Who Experience a ≥ 20% Decrease in FEV1 Compared to Baseline During the Aspirin Challenge [ Time Frame: Study Day 2 and 3 ]
  • 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 ]
  • Proportion of Patients With a ≥ 25% Increase in TNSS Compared to Baseline During the Aspirin Challenge [ Time Frame: Study Day 2 and 3 ]
  • 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
  • Incidence and Severity of Asthmatic Reactions During the Treatment Period [ Time Frame: Study Day 1 through 3 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2014)
  • 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 ]
  • Proportion of patients with a > 25%, 50%, or 75% 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 ]
  • Incidence and Severity of Treatment-emergent Adverse Events [ Time Frame: Up to Study Day 7 ]
  • Proportion of patients who experience a > 20% decrease in FEV1 compared to baseline during the aspirin challenge [ Time Frame: Study Day 2 and 3 ]
  • 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 ]
  • Proportion of patients with a > 25%, 50%, and 75% increase in TNSS compared to baseline during the aspirin challenge [ Time Frame: Study Day 2 and 3 ]
  • Amount of Rescue Medication Required During the Aspirin Challenge [ Time Frame: Study Day 2 and 3 ]
  • Incidence and Severity of Asthmatic Reactions During the Treatment Period [ Time Frame: Study Day 1 through 3 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Aspirin Exacerbated Respiratory Disease (AERD)
Intervention  ICMJE
  • Drug: Ifetroban, Oral Capsule
  • Drug: Placebo, Oral Capsule
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Drug: Placebo, Oral Capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2017)
19
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2014)
16
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02216357
Other Study ID Numbers  ICMJE CPI-IFE-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cumberland Pharmaceuticals
Study Sponsor  ICMJE Cumberland Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cumberland Pharmaceuticals
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP