NCT01459081已完成3 期
Randomised, Double-blind, Placebo-controlled Trial of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 298
- 试验地点
- 12
- 主要终点
- Time to alleviation of clinically important symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Zanamivir
Experimental
干预措施: Zanamivir (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to alleviation of clinically important symptoms
时间窗: up to 21 days
次要结局
- Symptom score AUC(6 days)
- Mean symptom scores(6 days)
- The use of relief medication(6 days)
研究者
研究点 (12)
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