A Randomized Double-blind Controlled Study of CS-8958 Versus Oseltamivir Phosphate in Patients With Influenza Virus Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,002
- 主要终点
- Time to Alleviation of Influenza Illness
研究概览
简要总结
The primary objective of this study is to confirm the efficacy of CS-8958 administered as a single inhaled low dose or single inhaled high dose by showing non-inferiority to oseltamivir phosphate using the time to alleviation of influenza illness. For safety evaluation, between-group comparisons will be made with regard to incidence of adverse events and other safety measures.
In a secondary objective, the optimum dosage of CS-8958 for this indication will be evaluated based on the efficacy and safety of single inhaled low or high dose.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of influenza
- •Axillary temperature of > or = to 37.5 degrees C
排除标准
- •Infection by bacteria species and/or virus other than influenza virus
- •Chronic respiratory disease
- •Renal dysfunction
研究组 & 干预措施
CS-8958 Low Dose
CS-8958 powder to be inhaled - low-dose arm
干预措施: CS-8958 (Drug)
CS-8958 High Dose
CS-8958 powder to be inhaled - high-dose arm
干预措施: CS-8958 (Drug)
Oseltamivir phosphate
oseltamivir phosphate oral capsules
干预措施: oseltamivir phosphate (Drug)
结局指标
主要结局
Time to Alleviation of Influenza Illness
时间窗: 15 days
The time to illness alleviation which was defined as the time from the initiation of trial treatment to the beginning of the first 21.5-h period in which all influenza symptoms were "absent" or "mild." Patients recorded their severity of influenza symptoms (headache, myalgia/arthralgia, fatigue, chills/sweats, nasal symptom, sore throat, and cough) 4 times daily for 15 days. Patients whose influenza symptoms had not been alleviated at the time of their withdrawal from the study or at the end of the observation period were censored.
次要结局
- Time for Body Temperature to Return to Normal(15 days)