Planning a Multicenter Oral Itraconazole Trial in Chronic Rhinosinusitis Patients

This clinical trial planning grant proposes to develop a prospective, multicenter, double-blind, placebo-controlled trial to investigate the efficacy of oral intraconazole in patients with chronic rhinosinusitis with nasal polyps. The specific aims include establishing a multicenter research team from 6 different medical centers in the USA, defining patient recruitment strategies, developing the study protocol, writing the investigator's brochure and the manual of operations, and developing tools for data management and research oversight. There are two main goals for the clinical trial:

1. to study the clinical and immunological efficacy of oral itraconazole treatment and,
2. to identify clinical parameters for those patients who are benefited by the treatment.