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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
166
Policlinico Santa Maria alle Scotte
Siena, Italy, Italy
Ospedale Cisanello
Pisa, Italy
Policlinico Univesitario Gemelli
Roma, Italy
proportion of patients who will experience clinical success
Time frame: 28 days
overall sinus symptoms
Time frame: 7,14,21,28 days
changes of each symptom
Time frame: 7, 14, 21, 28 days
level of work performance based on patient perception (recorded on a VAS scale of the diary card) and on missed working time
Time frame: 7, 14 days
absence of relapses
Time frame: 7, 14, 21, 28 days
nasal mucociliary transport time
Time frame: 7, 14 days
nasal air flow resistance
Time frame: 7, 14 days
Adverse events and adverse drug reactions
Time frame: 0, 7, 14, 21, 28 days
vital signs
Time frame: 0, 7, 14, 21, 28 days
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