NCT04999930已完成不适用
Comparison of Clinical Efficacy and Patient's Satisfaction of Tiotropium Respimat Administration With and Without Aerochamber in Patient With Chronic Obstructive Pulmonary Disease (COPD)
National University of Malaysia2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To compare the frequency of exacerbation (number of events ) and hospital admission (number of admissions) using tiotropium with and without aerochamber
研究概览
简要总结
COPD patient on Tiotropium Respimart divided into two group, Group A given aerochamber and Group B without aerochamber enroll in the study for total 18 week .
详细描述
- COPD patient who is on Tiotropium Respimart and other inhalers continued.
- Those fullfill inclusion criteria will be randomized into two group.
- To do Baseline CAT score and SGRQ questionnaires with Lung function test.
- Assess inhaler technique with and without aerochamber.
- Teach proper inhaler technique by templates and demonstrate to patients.
- Group A given aerochamber and Group B without aerochamber enroll in the study for total 18 week .
- First phase for 8 week after that 2 week of washout periode (without aerochamber both arm).
- Then Group A without aerochamber and Group B with aerochamber continue with all inhalers for 8 week.
- Followed up at 8th , 11th and 18th week to assess inhaler techniques ,Lung function test and do CAT score, and SGRQ questionnaire.
- Analysis data
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •COPD patients under Respiratory clinic UKM follow up
- •Patients who are with stable COPD (no exacerbation past 2 months)
- •Age same and more than 40-year-old
- •Patient able to perform inhaler medication
- •Patient able to perform technically acceptable pulmonary function test
排除标准
- •Drug hypersensitivity
- •Bronchial Asthma
- •Significant disease that may influence patient's ability to participate in the study.
- •Unable to provide signed informed consent
- •Mental condition rendering the subject unable to understand the nature, scope and the possible consequences of the study.
结局指标
主要结局
To compare the frequency of exacerbation (number of events ) and hospital admission (number of admissions) using tiotropium with and without aerochamber
时间窗: 18 weeks
Comparing frequency of exacerbation (number of events ) and hospital admission (number of admissions) in both groups
次要结局
- To assess quality of life (SGRQ questionaire)(18 weeks)
- Change of FEV1 (%) between the treatment group(18 weeks)
- Types of inhaler technique error between the group(18 weeks)
- To assess patients satisfaction and preference, attitudes, and perceptions about their inhalers using questionnaire(18 weeks)
研究者
Mohamed Faisal Abdul Hamid
Associate Professor Doctor
National University of Malaysia
研究点 (2)
Loading locations...
相似试验
已完成
3 期
A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol.Pulmonary Disease, Chronic ObstructiveNCT00274560Boehringer Ingelheim653
已完成
4 期
Differential Trough Effects of 'Triple Therapy' on Pulmonary Function in Chronic Obstructive Pulmonary Disease (COPD)COPDNCT00996697Brian J Lipworth23
撤回
2 期
Tiotropium Handihaler vs. Tiotropium Respimat in COPDChronic Obstructive Pulmonary Disease (COPD)NCT05838703Duke University
已完成
不适用
Assessment of Chronic Obstructive Pulmonary Disease (COPD) Therapy From the Physicians Perspective Using Tiotropium as an ExamplePulmonary Disease, Chronic ObstructiveNCT01036763Boehringer Ingelheim
已完成
4 期
Comparison of 24 Hour Bronchodilator Efficacy of Tiotropium 18 mcg Delivered Via DISCAIR Versus SPIRIVA 18 µg Delivered Via HANDIHALER® in Patients With Moderate to Severe COPDCOPDNCT02541006Neutec Ar-Ge San ve Tic A.Ş58