Trial intelligence / Profile preview

Inhaled Zanamivir for Influenza A and B in China

NCT01459081Phase 3

Key facts

Status
Completed
Start
Oct 2011
Primary completion
Dec 2012
Countries
1
Modality
Small Molecules
Conditions
Influenza A (IAV)influenza B
01

Overview

Phase 3, randomised, double-blind trial in Influenza A (IAV) and influenza B comparing Zanamivir with Placebo (2 arms). Primary endpoint: Time to alleviation of clinically important symptoms at 21 days. Started Oct 2011; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Zanamivir

    Zanamivir 10 mg inhaled twice daily for 5 days

  • Placebo

    Placebo inhaled twice daily for 5 days

03

Who it enrols

Patients with fever >38.0C and influenza-like symptoms starting within 48 hours. Excludes patients with respiratory diseases (asthma, COPD), liver/renal impairment, recent flu vaccination, or HIV.

04

Endpoints

Primary

  • Time to alleviation of clinically important symptoms

Secondary

  • Symptom score AUC

  • Mean symptom scores

  • The use of relief medication

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