A Phase 2 Multicenter, Double-blind, Randomized, Placebo-Controlled Trial to Evaluate Oral Ifetroban in Subjects with Symptomatic Aspirin Exacerbated Respiratory Disease (AERD)

A Phase 2 Multicenter, Double-blind, Randomized, Placebo-Controlled Trial to Evaluate Oral Ifetroban in Subjects with Symptomatic Aspirin Exacerbated Respiratory Disease (AERD)
Recruiting
18 years - 100 years
All
Phase 2
1 Location

Brief description of study

The primary purpose of this study is to determine the therapeutic effectiveness of Ifetroban to improve sinus and nasal symptoms and quality of life in subjects with Aspirin Exacerbated Respiratory Disease (AERD).

Detailed description of study

This is a phase 2 multicenter, randomized, double-blind, placebo controlled study to evaluate the effects of 200 mg of oral ifetroban administered once daily for eight (8) weeks. Approximately 76 subjects will be randomized into two treatment groups of 38 subjects per group. One group will received the study drug ifetroban and the other will receive placebo. For inclusion in the study, patients must sign consent form and meet all of the criteria within 2 weeks of starting treatment. These subjects will be randomized into one of the treatment groups and receive treatment daily over the course of 8 weeks. There are a total of five (5) required visits starting from screening, Visit 1 to post-treatment, visit 5. A patient diary will be used to record dates and times of all medication received to monitor compliance as well as frequency and severity of flare-ups, antibiotic and rescue medication use, and to record Total Nasal Symptom Scores twice daily.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Asthma, Nasal polyps
  • Age: 18 years - 100 years
  • Gender: All
Updated on 19 Feb 2024. Study ID: 827136

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