drugset / Trial / NCT01691677

beCLomethasone Efficacy in Acute Rhinosinusitis - CLEAR Study

NCT01691677

Phase 3 Completed 166 enrolled Chiesi Farmaceutici S.p.A.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Intranasal corticosteroids are beneficial in the treatment of acute rhinosinusitis. As adjunctive therapy to oral antibiotic treatment, mometasone furoate at doses of 200 μg or 400 μg twice daily, was well tolerated and significantly more effective in reducing the symptoms of rhinosinusitis than antibiotic therapy alone. Furthermore,the addition of fluticasone propionate to xylometazoline and antimicrobial therapy with cefuroxime improved clinical success rates and accelerated recovery of patients with a history of chronic rhinitis or recurrent sinusitis who present for treatment of acute rhinosinusitis. The present study was planned to assess the effects of nebulised beclomethasone dipropionate given as add-on therapy to standard care (oral antibiotics) in the treatment of acute symptomatic rhinosinusitis. Antibiotic therapy will be at the physicians' discretion.

Timeline

Start
2013-01
Primary completion
2014-01
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Subject beclomethasone dipropionate Other / unclassified 800 ug Other

Indications