Analysis of binary outcome derived from frequent longitudinal data: Application to daily pain evaluation

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Efficacy of fusafungine in acute rhinopharyngitis: A poole analysis

Upper respiratory tract infections are generally mild but they are associated with an enormous loss in productivity. Treatment consists of reduction of local symptoms e.g. local inflammation and prevention of potential superinfections. Besides its bacteriostatic activity against most micro-organisms involved in respiratory tract infections fusafungine displays original anti-inflammatory properties.To optimise nasal and throat deposition, a new fusafungine oro-nasal spray using HFA 134a was developed and its efficacy was evaluated in patients with acute rhinopharyngitis based on improvement of significant nasal symptoms. Three randomised double-blind placebo-controlled parallel-group studies with identical objectives design and dosage were performed and results were pooled for a better evaluation of treatment effect (532 patients).The percentage of responders (patients with nasal symptom score improvement from Day 0 to Day 4) was 61.5 +/- 2.9% with fusafungine vs 46.8 +/- 3.1% with placebo (p=0.009) with an odds ratio of 1.8 (p=0.01) in favour of fusafungine. The nasal symptom score distribution at Day 4 showed an odds ratio of 1. 56 (p=0.011) also in favour of fusafungine. For patients treated early (onset of symptoms $1 day) the percentage of responders was 65.9 +/- 4.1% with fusqfungine vs 38.3 +/- 4.0% with placebo (p=0.022) with an odds ratio of 3.08 (p=0.033) in favour of fusafungine.Therefore fusafungine through its dual bacteriostatic and original anti-inflammatory properties is an effective treatment of acute rhinopharyngitis especially when administered early