Efficacy and Safety of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

298 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-12-31

Brief Summary

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The aim of this study is to evaluate the clinical efficacy and safety of inhaled zanamivir in treatment of influenza A and B virus infections in China.

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Detailed Description

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Conditions

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Influenza A Virus Infection Influenza B Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zanamivir

Group Type EXPERIMENTAL

Zanamivir

Intervention Type DRUG

10 mg inhaled by mouth, twice daily, for 5 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

inhaled by mouth, twice daily, for 5 days

Interventions

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Zanamivir

10 mg inhaled by mouth, twice daily, for 5 days

Intervention Type DRUG

Placebo

inhaled by mouth, twice daily, for 5 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Who had fever (\>38.0ºC)
* At least two of the following symptoms: chills, headache, myalgia, fatigue, nasal symptoms, sore throat, cough
* Started therapy within 48 hours of onset of influenza-like illness
* Written informed consent

Exclusion Criteria

* Respiratory diseases, such as asthma or COPD
* Woman with a positive urine pregnancy test
* Woman without contraception during the study
* Allergic to zanamivir, Paracetamol or lactose
* WBC ≥ 10.5×109/L; neutrophil percentage ≥ 80%
* Hepatic function impairment: AST ≥ 2×ULN, ALT ≥ 2×ULN
* Renal function impairment: Cr \> 221μmol/L
* Influenza vaccination in the 12 months prior the beginning of the study
* History of tumor, psychiatric disorders, epilepsy or drug abuse
* Patients receiving corticosteroids, immunosuppressants
* HIV positive

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No