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

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).

Clinical Study Identifier: TX4806

Detailed Study Description

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.

Additional Information About The Study

Basic Eligibility Criteria • History of Physician-diagnosed asthma • History of nasal polyps • History of at least 2 reactions to oral aspirin or other Nonsteroidal anti-inflammatory drug (NSAID) with features of lower airway involvement (cough, chest tightness, wheezing, shortness of breath) or diagnosis of AERD via a physician conducted challenge to aspirin in the last 5 years before starting treatment. • Not currently smoking tobacco • Not currently pregnant or breastfeeding • Not currently taking Aspirin or any NSAID • No History of bleeding problems or taking other blood thinners • There are more potential exclusions which will be discussed with you if you are interested and meet the above criteria Site Location: Perelman Center for Advanced Medicine Department of Otorhinolaryngology 3400 Civic Center Blvd, 3rd Floor South Pavilion Philadelphia PA 19104 For further information contact: Laurel Doghramji, RN, BSN Study Coordinator at 215-615-1643 or Laurel.doghramji@uphs.upenn.edu

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To: Research Study Investigator
Subject: I am interested in participating in your Research Study
Dear Investigator,
I'm interested in learning more about and participating in your research study named: A Phase 2 Multicenter, Double-blind, Randomized, Placebo-Controlled Trial to Evaluate Oral Ifetroban in Subjects with Symptomatic Aspirin Exacerbated Respiratory Disease (AERD)
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