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

Phase 3

Completed

• Conditions: Influenza A Virus Infection; Influenza B Virus Infection
• Interventions: Drug: Zanamivir; Drug: Placebo

• Registration Number: NCT01459081
• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-21
• Study First Submitted QC: 2011-10-24
• Study First Posted: 2011-10-25
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-15
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zanamivir	Zanamivir	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Time to alleviation of clinically important symptoms	up to 21 days

Secondary Outcome Measures

Name	Time	Method
Symptom score AUC	6 days
Mean symptom scores	6 days
The use of relief medication	6 days

Trial Locations

Locations (12)

The Third Xiangya Hospital Of Central South University; 🇨🇳 Changsha, China

The First People's Hospital of Hangzhou; 🇨🇳 Hangzhou, China

The Affiliated Hospital of Inner Mongolia Medical College; 🇨🇳 Huhehaote, China

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, China

Northern Jiangsu People's Hospital; 🇨🇳 Yangzhou, China

Qingdao Municipal Hospital; 🇨🇳 Qingdao, China

ShengJing Hospital of China Medical University; 🇨🇳 Shenyang, China

Tangdu Hospital Affiliated to the Fourth Military Medical University; 🇨🇳 Xi'an, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, China

Shanghai 6th People's Hospital; 🇨🇳 Shanghai, China

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, China