drugset / Trial / NCT05157685

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

NCT05157685

Phase 3 Recruiting 230 enrolled Centre Hospitalier Intercommunal Creteil
RandomizedParallel-groupTriple-blindTreatment

Summary

Purulent Oedematous Sinusitis (POS) is a particular form of chronic rhinosinusitis observed in 2% of the general population. In spite of its heavy impact on the quality of life, There is no established recommendation for the treatment of primary POS. Long-term low-dose macrolides are currently proposed for these forms of chronic rhinosinusitis when conventional treatments (local corticosteroids, saline rinsing, iterative short courses of antibiotics targeted on pathogens, and surgical opening and drainage) have failed. This treatment with macrolides is currently applied off-label. This study aims to assess the efficacy of macrolides in POS. An extensive workup is fulfilled to exclude other forms of chronic rhinosinusitis (Th2 biased inflammatory diseases, allergic diseases) (allergy, nasosinusal polyposis) or those due to cystic fibrosis or immune deficiency.

Timeline

Start
2022-11-21
Primary completion
2027-11-21
Completion
2027-11-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Azithromycin Small molecule 250 mg Oral