Evaluation of the Efficacy of Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults
Evaluation of the Efficacy of 3-month Continuous Extended Treatment With Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults: a Multicentre Randomised Controlled Trial
Centre Hospitalier Intercommunal Creteil
230 participants
Nov 21, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
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Interventions
Treatment assigned by randomization will be prescribed immediately. The active or placebo will be dispensed by the centre's pharmacy. Treatment will be taken in the morning or evening for 3 months.
Treatment assigned by randomization will be prescribed immediately. The active or placebo will be dispensed by the centre's pharmacy. Treatment will be taken in the morning or evening for 3 months.
Locations(13)
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NCT05157685