NCT01287325已完成1 期
A Multi-centre, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Clinical Efficacy, Tolerability and Safety of Two Weeks Treatment With DNK333 100 mg Bid in Patients With COPD and Cough.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Self-reported cough
研究概览
简要总结
This study evaluates the efficacy and safety of two weeks treatment of DNK333 in patients with COPD and cough.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate COPD
- •Forced expiratory volume in 1 second (FEV1) ≥30% predicted
- •FEV1/FVC (forced vital capacity) <70%
- •Significant amount of cough and minimal amount of sputum production, both as judged by self reporting
- •Exclusion criteria:
- •Upper or lower airway infection within 4 weeks prior to screening
- •COPD exacerbation within 4 weeks prior to screening
- •Past history or current diagnosis of congestive heart failure, cirrhosis or hepatic failure
- •History of lung cancer or pulmonary resection/thoracic radiotherapy
- •Other protocol-defined inclusion/exclusion criteria may apply
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
DNK333
Experimental
干预措施: DNK333 100 mg twice daily (Drug)
结局指标
主要结局
Self-reported cough
时间窗: At 2 weeks
次要结局
- Sensitivity to capsaicin challenge(At 2 weeks)
研究者
研究点 (1)
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