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

Simcere

Status and phase: Completed; Phase 3

Conditions: Influenza B Virus Infection; Influenza A Virus Infection

Treatments: Drug: Zanamivir; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01459081

SIM-100

Details and patient eligibility

About

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.

Enrollment: 298 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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298 participants in 2 patient groups, including a placebo group

Zanamivir

Experimental group

Treatment:

Drug: Zanamivir

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo