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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Treatments: Zanamivir

Criteria

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