Evaluation of 3-month Continuous Azithromycin Treatment in Adults with Idiopathic Purulent Oedematous Sinusitis A Multicentre Randomized Controlled Trial

What this Trial Is About

Purulent Oedematous Sinusitis (POS) is a specific type of chronic rhinosinusitis affecting about 2% of people, significantly impacting daily and professional life. This condition can be idiopathic or secondary to other diseases like cystic fibrosis or immune deficiencies. Researchers are evaluating the effectiveness of long-term, low-dose macrolides, particularly azithromycin, for treating primary POS where other conventional treatments have failed. The study excludes other forms of chronic rhinosinusitis caused by allergies or certain immune issues to focus specifically on this form. Participants will be randomly assigned to receive either azithromycin 250 mg once daily or a placebo for three months. The treatment is taken either in the morning or evening, with or without meals. The study is a triple-blind, randomized controlled trial conducted at multiple centers. Researchers will use specialized tools to assess the impact of azithromycin on mucociliary clearance, including advanced microscopy techniques to measure ciliary beat efficiency. During the study, participants will undergo various assessments including symptom scales, nasal endoscopy, CT scans, nasal inflammation evaluation, quality of life questionnaires, and bacterial sampling. Safety monitoring includes tracking clinical and biological adverse events and audiometric testing. The primary outcome is the comparison of sinonasal outcome test (SNOT) 22 scores after three months, with additional monitoring up to six months to evaluate symptom persistence, quality of life, and mucociliary function. Total participation includes follow-up for up to six months after treatment starts.

Evaluation of the Efficacy of Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults