drugset / Trial / NCT00980109
Long Term Influenza Prophylaxis With Inhaled Zanamivir or Oral Oseltamivir
Phase 4
Completed
390 enrolled
University of Oxford
National Institute of Allergy and Infectious Diseases (NIAID) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Oseltamivir | Small molecule | 75 mg | Oral |
| Comparator | Zanamivir | Small molecule | 10 mg | Inhaled |