NCT04696965已完成不适用
Appropriate Inhaler Use of Tiotropium As Add-on Therapy to Inhaled Glucocorticoids (ICS) with Long-acting Beta-agonists (LABA) in Adult Patients with Symptomatic Asthma: the Impact of Checking and Correcting Inhaler Technique in Real World
Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年3月4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
- 48
- 试验地点
- 2
- 主要终点
- Errors rate of Inhaler steps
研究概览
简要总结
This pragmatic, two-arm, randomized controlled trial study aim to survey the inhaler errors of add-on tiotropium therapy with ICS+LABA in real-world practice of asthma patients and the efficacy of recheck stratage of inhaler skills. Patient characteristics and inflammatory features will be evaluated prospectively for association of asthma control by add-on tiotropium.
详细描述
- The clinical efficacy of tiotropium as add-on treatment to ICS with a LABA have been demonstrated in clinical trials in adult patients with symptomatic asthma.
- Certain patients of daily care, like patients with smoking asthma, late onset asthma or asthma with chronic airway obstruction are often excluded from clinical trials.
- Studies have shown the cognitive function of patients with COPD is impaired. When mixed types of inhaler devices are prescribed, the multiple steps of different devices may ensure complexity and confusion for patients, which may compromise the efficacy of add-on therapy. The inhaler error of add-on tiotropium treatment in real-world asthma treatment is unknown.
- The improvement of step errors after varieties of teaching intervention is around 30~50%. Strategy of recheck inhaler technique recommended by the treatment guideline may optimized inhaler use. (https://ginasthma.org/gina-reports/).
- Factors like responseness of short-acting bronchodilators and cholinergic tone have been reported as predictors of a positive clinical response of add-on tiotropium. However, more specific physiological or inflammatory factors. e.g. exhaled nitric oxide test (FeNo), and para symptomatic function and cardiac-pulmonary interaction have not been evaluated prospectively.
- This pragmatic, two-arm, randomized controlled trial study aim to survey the inhaler errors of add-on tiotropium therapy with ICS+LABA in real-world practice of asthma patients and the efficacy of recheck stratage of inhaler skills. Patient characteristics and inflammatory features will be evaluated prospectively for association of asthma control by add-on tiotropium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
The subjects enrolled will be informed the purpose of this study is to evaluate the inhaler step errors after add-on tiotropium with the other ICS+LABA inhaler and how the education improve patients to reduce the error rate. The subjects are not aware the different methods of study arm and control arm.
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 75 years old asthmatic patients under regular treatment
- •Received medium to high dose ICS with LABA at least 3 months
- •Persistent asthma related symptoms: asthma control questionnaire (ACQ-7>1.5)
- •Physicians in charged prescribed Tiotropium as add-on therapy according to clinical judgement.
排除标准
- •Refuse to provide inform consent
- •Pregnancy or breastfeeding women
- •Patients with chronic obstructive pulmonary disease
- •Using other Long-acting Muscarinic Antagonists e.g. Sebree, Ultibro, Anoro and Spiolto
结局指标
主要结局
Errors rate of Inhaler steps
时间窗: 3 months
The improvement of inhaler steps errors after recheck stratage after 3 month of add-on tiotropium and ICS+LABA
次要结局
- Acute exacerbation(3, 6,9 and 12 month)
- Forced expiratory volume in one second (FEV1) before bronchodilation(3 months)
- Asthma control(3 months)
研究者
Ting-Yu Lin
Attending physician
Chang Gung Memorial Hospital
研究点 (2)
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