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

NCT02216357 | Completed Phase 2 Results

• 1 other identifier: CPI-IFE-003
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

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.

Conditions

Aspirin Exacerbated Respiratory Disease (AERD)

Keywords

Samster's triad; Acetylsalicylic acid triad; Widal's triad; Francis' triad; Aspirin triad; Aspirin-induced asthma and rhinitis (AIAR)

Outcome Measures

Primary Outcomes (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

  Study Day 2

Secondary Outcomes (9)

• 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

  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

  Up to Study Day 2

• Incidence and Severity of Treatment-emergent Adverse Events

  Up to Study Day 7

• Proportion of Patients Who Experience a ≥ 20% Decrease in FEV1 Compared to Baseline During the Aspirin Challenge

  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

  Study Day 2 and 3

Study Arms (2)

Ifetroban, Oral Capsule

ACTIVE COMPARATOR

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, Oral Capsule

PLACEBO COMPARATOR

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

Interventions

Ifetroban, Oral Capsule DRUG

Ifetroban, Oral Capsule

Placebo, Oral Capsule DRUG

Placebo, Oral Capsule

Eligibility Criteria

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

You may qualify if:

• 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).
• Have a history of nasal polyposis.
• 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.
• 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.

You may not qualify if:

• Be less than 18 years of age or greater than or equal to 65 years of age.
• Be pregnant, nursing, or planning to become pregnant.
• 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).
• Use of a beta blocker in the last week.
• Use of an antihistamine in the 48 hours prior to the first dose of IMP.
• Use of nasal decongestants in the 48 hours prior to the first dose of IMP.
• Use of aspirin or non-steroidal inflammatory drug (NSAID) in the last two weeks.
• Use of zileuton in the last two weeks.
• Have required one or more doses of ≥ 40 mg prednisone or equivalent in the last two weeks.
• Have a history of systemic or life-threatening respiratory reaction to aspirin requiring intubation or administration of epinephrine.
• 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.
• Have a history of tolerating a COX-1 blocking drug after their history of a respiratory reaction to a similar drug.
• Have a history of cardiovascular disease including myocardial infarction, heart failure, atrial or ventricular rhythm disturbances, or angina, or a previous abnormal electrocardiogram.
• Have a history of bleeding diathesis or use of anticoagulant or antiplatelet drugs in the last two weeks.
• Have a history of allergy or hypersensitivity to ifetroban.

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (3)

Scripps Clinic

San Diego, California, 32130, United States

Location

Kansas City Allergy and Asthma Associates, PA.

Overland Park, Kansas, 66210, United States

Location

Allergy & Asthma Consultants of Rockland & Bergen

West Nyack, New York, 10994, United States

Location

MeSH Terms

Conditions

Asthma, Aspirin-Induced; Rhinitis

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; Respiratory Tract Infections; Infections; Nose Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Senior Manger, Clinical Operations
• Organization: Cumberland Pharmaceuticals Inc.

bkaelin@cumberlandpharma.com

615-255-0068

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: August 12, 2014
• First Posted: August 13, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 15, 2017
• Results First Posted: March 22, 2017

Record last verified: 2017-04

Locations

US (3)