NCT00599417已完成4 期
Prospective, Pivotal Unicentre, Randomized Double-bind, Placebo-controlled Study, to Evaluate Efficacy and Safety of Bacterial Lysates (Pulmonarom) in the Prevention of Respiratory Tract Infections
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Decrease of interleukin-4/interferon gamma index at baseline values
研究概览
简要总结
Primary
- To evaluate the efficacy of Pulmonaron in the decrease of interleukin-4/interferon gamma after second period of treatment
Secondary
- To evaluate the efficacy of Pulmonarom in the prevention of upper respiratory tract infections symptoms through patient evaluation of fever or respiratory presence after second period of treatment
- To evaluate loss of working or study days after second period of treatment
- To evaluate the safety and tolerability of Pulmonarom in the population under study
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with history of relapse or recurrence of respiratory infections or disease
- •Patients with chronic respiratory disease as asthma, bronchitis or sinusitis
排除标准
- •Patients unlikely to comply with the protocol, for example, uncooperativeness or impossibility to return for follow-up visits
- •Patients who are participating or who have participated in another clinical trial during the previous 3 months
- •Patients who have received immunology response stimulants during the previous 30 days
- •Hypersensitivity
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
干预措施: Bacterial Lysates (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Decrease of interleukin-4/interferon gamma index at baseline values
时间窗: 60 days, 120 days
次要结局
- Adverse events and laboratory evaluation(120 days)
研究者
研究点 (1)
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