A Phase 2 Multicenter, Double-blind, Randomized, Placebo-Controlled Trial to Evaluate Oral Ifetroban in Subjects With Symptomatic Aspirin Exacerbated Respiratory Disease (AERD) (NCT03028350)

Purpose

The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs.

Interventions

Drug: Ifetroban Oral Capsule
Subjects will be treated with oral ifetroban daily for 8 weeks
- Ifetroban
Drug: Placebo Oral Capsule
Subjects will be treated with oral placebo daily for 8 weeks
- Placebo

Ages eligible for Study	18 Years and older
Genders eligible for Study	All
Accepts Healthy Volunteers	No

Inclusion Criteria:

History of physician-diagnosed asthma
History of nasal polyposis
History of at least two reactions to oral aspirin or other nonselective cyclooxygenase inhibitor with features of lower airway involvement (cough, chest tightness, wheezing, dyspnea), or a diagnosis of AERD by a physician-conducted challenge to aspirin in the last five years before starting treatment.
Stable asthma (post-bronchodilator FEV1 of ≥ 60%, no glucocorticoid burst for at least two weeks prior to starting treatment, no hospitalizations or emergency room visits for asthma at least three months prior to starting treatment and not on a dose >1000 µg fluticasone or equivalent daily).
≥ 18 years of age
Exhibit symptomatic AERD within two weeks of starting treatment by demonstrating a score of at least 20 on the Sino-nasal Outcome Test (SNOT) - 22.

Exclusion Criteria:

Current smoking, defined as daily tobacco smoking in the last six months and at least one instance of tobacco smoking in the last three months.
Current pregnancy or breastfeeding
Use of oral or systemic steroids (e.g. prednisone or equivalent) > 20 mg daily in the last four weeks before starting treatment.
Daily use of long-acting antihistamines, 5-lipoxygenase inhibitors (e.g. zileuton) and leukotriene receptor antagonists (e.g. montelukast) in the last two weeks before starting treatment.
Less than 12 months of allergy shots (maintenance dose of allergy shots are allowed if treatment duration exceeds 12 months).
Any use of nonsteroidal anti-inflammatory drugs (NSAIDs) or any drug that inhibits the cyclooxygenase enzyme in the last two weeks before starting treatment.
History of bleeding diathesis or use of anticoagulant or antiplatelet drugs in the last two weeks before starting treatment.
Any immunosuppressive treatment including but not limited to methotrexate, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine, hydroxychloroquine, azathioprine, cyclophosphamide, and immunotherapy in the last two weeks before starting treatment (maintenance dose of allergy shots are allowed if treatment duration exceeds 12 months).
Endoscopic sinus surgery / polypectomy within the past three months
Previously treated in a clinical trial with ifetroban within the past three months.
Previously treated with other investigational drugs within eight weeks or five half-lives, whichever is longer, before screening
Conditions/concomitant disease which make them unevaluable for the efficacy endpoints

This is a randomized, placebo-controlled, double-blind phase 2 trial evaluating approximately 76 subjects with symptomatic AERD on the safety and efficacy of 8 weeks of oral ifetroban treatment. Eligible AERD subjects will be randomized to receive 8 weeks of either oral ifetroban daily or matching placebo followed by a 2-week post-treatment period.

10 locations

Overview

Status:

recruiting

Type:

Interventional

Phase:

Ⅱ

Start:

16 July, 2017

Updated:

02 January, 2018

Participants:

Trial rating

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