Cough Suppressive Therapy in Chronic Cough: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Leicester Cough Questionnaire (LCQ)
研究概览
简要总结
In this randomized, placebo-controlled, interventional study on chronic cough a non-pharmacological cough suppressive therapy is the intervention to be studied, with a control group receiving treatment consisting of general healthy lifestyle advice. The following data will be collected before, after and up to six months after treatment: Standardized questionnaires for diagnosis of background factors, Leicester Cough Questionnaire (LCQ), Work Ability Index (WAI), and cough frequency as well as lung function and biomarkers.
The primary treatment effect measurement will be changes in chronic cough-related quality of life, measured by the Leicester Cough Questionnaire (LCQ).
详细描述
The study will be carried out in collaboration between respiratory physicians, clinical physiologists, physiotherapists, speech- and language therapists and gastroenterologists.
The primary hypothesis of the planned study is:
The cough suppressive therapy improves chronic cough-related quality of life and work ability, and is sustained over six months after treatment.
The secondary hypotheses of the planned study are:
Treatment of chronic cough by the cough suppressive therapy can reduce cough frequency (measured by an automated cough detector), airway inflammation and airway resistance.
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
- Double (Investigator, Outcomes Assessor)
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
- •Chronic cough (duration >2 months) without a structural lung disease and a normal chest X-ray, which have failed pharmacological treatment.
- •Being able to understand the swedish language.
排除标准
- •Pulmonary abnormalities on a chest X-ray, structural lung disease, or chronic obstructive pulmonary disease (COPD) of spirometry stage Global Initiative for Obstructive Lung Disease (GOLD) 2 or higher.
- •Smoking under the last three months.
- •Ongoing or recent treatment with angiotensin-converting enzyme (ACE) inhibitor
- •Active aspiration, vocal cord nodules or upper respiratory tract infection in the previous 4 weeks.
结局指标
主要结局
Change in Leicester Cough Questionnaire (LCQ)
时间窗: Change from baseline LCQ at one week and 6 months after completed intervention
Leicester Cough Questionnaire (LCQ) is an English-born self-reporting quality of life measure of chronic cough,
次要结局
- Change in the hypersensitivity of the cough reflex(Change from baseline hypersensitivity of the cough reflex at one week after completed intervention)
- Change in inflammation biomarkers in blood; eosinophil count(Change from baseline inflammation biomarkers (eosinophil count) in blood at one week after completed intervention)
- Change in The Work Ability Index (WAI)(Change from baseline WAI at one week and 6 months after completed intervention)
- Change in Cough frequency(Change from baseline cough frequency at one week and 6 months after completed intervention)
- Change in inflammation biomarker fractional exhaled nitric oxide (FeNO)(Change from baseline FeNo at one week after completed intervention)
- Change in inflammation biomarkers in blood; level of eosinophil cationic protein (ECP)(Change from baseline inflammation biomarkers in blood (ECP) at one week after completed intervention)