Status:
COMPLETED
Efficacy and Safety of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions:
Influenza A Virus Infection
Influenza B Virus Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT01459081
Start Date
October 1 2011
End Date
December 1 2012
Last Update
January 16 2013
Active Locations (12)
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1
The Third Xiangya Hospital Of Central South University
Changsha, China
2
West China Hospital, Sichuan University
Chengdu, China
3
The First People's Hospital of Hangzhou
Hangzhou, China
4
The Affiliated Hospital of Inner Mongolia Medical College
Hohhot, China