drugset / Trial / NCT00980109

Long Term Influenza Prophylaxis With Inhaled Zanamivir or Oral Oseltamivir

NCT00980109

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This is a multicenter, randomised, four arms placebo controlled study to evaluate the safety and tolerability of 10 mg inhaled zanamivir once a day and 75 mg oseltamivir capsule orally once a day relative to placebo over 16 weeks (112 days). Enrolled subjects will be randomly assigned to 2:1:2:1 ratio (active oseltamivir: placebo: active zanamivir: placebo) on one of the four study treatment groups. It is hypothesized that oseltamivir and zanamivir will protect participants from becoming infected with influenza.

Timeline

Start
2009-09
Primary completion
2010-09
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Oseltamivir Small molecule 75 mg Oral
Comparator Zanamivir Small molecule 10 mg Inhaled

Indications