NCT02379637已完成2 期
A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multiple-Dose, Proof-of-Concept Study to Evaluate the Efficacy of N-acetylcysteine Capsules in the Treatment of the Common Cold (Viral URTI) Associated With Cough in an Adult Population
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 70
- 主要终点
- Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours)
研究概览
简要总结
This study is designed to improve knowledge regarding the initial effectiveness of N-acetylcysteine (NAC) on cold and cough symptoms.
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
- •Cold/URTI symptoms occurring no more than 4 days
- •cough due to a cold or acute viral (URTI) with an onset of no more than 3 days
- •cough frequency with specified cut-off
排除标准
- •A subchronic, or chronic cough (cough duration > 2 months) due to any condition other than a cold/URTI
- •Diagnosed as suffering from any pulmonary conditions associated with cough, e.g., chronic obstructive pulmonary disease (COPD), acute or chronic bronchitis, asthma, cystic fibrosis
- •Taking any medications known to induce cough
- •Fever of greater than 39°C (102°F) orally
- •Complication of the common cold like otitis media, severe sinusitis, or pneumonia
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
A N-acetylcysteine
Experimental
N-acetylcysteine
干预措施: N-acetylcysteine (Drug)
B Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours)
时间窗: 72 hours
Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours
次要结局
- Safety of Daily Dose of NAC (Number of Patients With Adverse Advents)(7 Days)
研究者
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