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Long Term Influenza Prophylaxis With Inhaled Zanamivir or Oral Oseltamivir

NCT00980109 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2010-09-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

active oseltamivir

Oseltamivir capsules (75 mg per capsule), one capsule daily by mouth (PO) for 112 days. The dose should be administered at approximately the same time each day.

DRUG

placebo capsule

Placebo capsules, one capsule daily for 112 days. The capsule should be administered at approximately the same time each day.

DRUG

zanamivir for inhalation

Zanamivir for inhalation, (5 mg per inhalation), two inhalations, once daily using a ROTADISK/DISKHALER for 112 days. The dose should be administered at approximately the same time each day.

DRUG

placebo for inhalation

Placebo (lactose powder), two inhalations, once daily using a ROTADISK/ DISKHALER for 112 days. The dose should be administered at approximately the same time each day.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Oxford

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00980109 on ClinicalTrials.gov