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QUESTION: In patients with symptoms of influenza, what is the clinical efficacy and safety of zanamivir?
Design
Randomised {allocation concealed*}†, blinded (clinicians and patients),* placebo controlled trial with 21 day follow up.
Setting
Clinical centres in North America and Europe.
Patients
1256 patients (mean age 35 y, 66% women) who presented with symptoms of influenza of ≤48 hours of duration during 1 influenza season: fever and ≥2 of myalgia, headache, cough, or sore throat. Exclusion criteria were unstable chronic illness, receipt of other antiviral agents in the previous 7 days, inability to use inhaler devices satisfactorily, known or suspected hypersensitivity to study medication, pregnancy, lactation, or potential for pregnancy. 1182 patients (94%) completed the study.
Intervention
Patients were allocated to 5 days of treatment with zanamivir, 10 mg by oral inhalation and 6.4 mg by nasal spray 2 times/day (n=419); zanamivir (same dosages and administration routes) 4 times/day (n=415); or placebo (n=422).
Main outcome measures
Time to alleviation of clinical symptoms, which had to be maintained for ≥24 hours. Secondary outcomes were mean symptom score, sleep disturbance, time to return to normal activities, and use of acetaminophen and dextromethorphan to relieve symptoms.
Main results
Analysis was by intention to treat. Both regimens of zanamivir reduced the time to alleviation of clinical symptoms by 1 day less than placebo (6 …