Rhinitis, sinusitis, and ocular diseasesTreating acute rhinosinusitis: Comparing efficacy and safety of mometasone furoate nasal spray, amoxicillin, and placebo
Section snippets
Study design
This randomized, double-blind, double-dummy, placebo-controlled study was conducted at 71 medical centers in 14 countries from January to September 2003. The study compared the efficacy and safety of MFNS 200 μg once daily with MFNS 200 μg twice daily to establish the minimally effective MFNS dose.
The study was conducted in accordance with the Declaration of Helsinki and guidelines on Good Clinical Practice. Subjects who were eligible at the screening visit (visit 1) and baseline visit (visit
Subject disposition and characteristics
A total of 981 subjects were randomized to treatment. Each subject received at least 1 dose of study drug and was included in the efficacy and safety analyses. There were no clinically relevant differences in demographic characteristics between the treatment groups, and baseline symptom data were comparable (Table I). Mean MSS at baseline was 8.17 to 8.53 across the 4 treatment groups, indicating that most subjects had mild-to-moderate disease. Less than 22% and 29% of subjects had a history of
Discussion
It has been shown that acute rhinosinusitis frequently resolves without medical intervention. This is most likely a result of the underlying viral and/or bacterial pathology of acute rhinosinusitis. Nevertheless, considering the host of symptoms associated with acute rhinosinusitis, recovery can take time and be of substantial discomfort to the affected patient. Although antibiotics have been the mainstay of therapy,20, 21 recent evidence has suggested that intranasal corticosteroids can
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Disclosure of potential conflict of interest: E. Meltzer received grant support from Schering-Plough for this study and is a consultant on the speakers' bureau and has received grants from numerous pharmaceutical companies. H. Staudinger and C. Bachert have disclosed no conflict of interest.
Supported by a grant from the Schering-Plough Research Institute.