A Randomized Crossover Trial Comparing the Efficacy and Safety of Tiotropium + Procaterol vs. Tiotropium + Placebo in Moderate COPD Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- [Efficacy] Improvement spirometry (FEV1, FVC, FEV1/FVC, 6 MWD, TDI) and SGRQ at 2 weeks
研究概览
简要总结
Study compares the efficacy and safety of tiotropium + a beta agonist (procaterol) vs. tiotropium alone among patients with moderate chronic obstructive pulmonary disease
详细描述
This study aims to determine the efficacy and safety of tiotropium plus procaterol in comparison to tiotropium plus placebo in Filipino patients seen in Manila, with moderate COPD.
After a 1-week wash-out period, 6-minute walk test, and St. George's Respiratory Questionnaire (SGRQ) will then be administered prior to a run-in period of 1 week wherein all patients will be started on tiotropium alone. The patients will then be randomly allocated to either of the two arms for a two-week treatment, followed by one week washout, and crossed-over to the other treatment for another two weeks. The procaterol or placebo dose is given 2 hrs after the tiotropium dose.
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
- Double
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GOLD criteria for moderate COPD (post-bronchodilator)
- •FEV1/FVC < 70%
- •50% ≤ FEV1 < 80% predicted
- •With or without symptoms
- •Willing to undergo the treatment protocol with signed informed consent
排除标准
- •Exacerbation within 1 month prior to run-in period
- •Significant hypoxemia and/or desaturation at rest and during exercise.
- •Significant cardiac, renal, or other systemic disease
- •History of adverse reaction to any of the two test drugs (tiotropium and procaterol)
结局指标
主要结局
[Efficacy] Improvement spirometry (FEV1, FVC, FEV1/FVC, 6 MWD, TDI) and SGRQ at 2 weeks
次要结局
- [Safety] HR (Heart Rate) and BP (Blood Pressure)
- Incidence of adverse reactions and changes