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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Cumberland Pharmaceuticals

Current Primary Outcome: 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: 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 ]

Current Secondary Outcome:

  • 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:

  • 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 ]


Information By: Cumberland Pharmaceuticals

Dates:
Date Received: August 12, 2014
Date Started: August 2014
Date Completion:
Last Updated: April 9, 2017
Last Verified: April 2017