A Double Blind, Placebo Controlled Multicentre Study of the Effects of Standard Care Plus Erdosteine (Erdotin) Versus Standard Care Plus Placebo on Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- 24 hr cough recording
研究概览
简要总结
This is a parallel group, double-blind, placebo controlled, multi-centre, randomised trial.
60 patients to be included who are adult patients admitted to hospital with a clinical diagnosis of acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Acute exacerbation of COPD will be defined as sustained worsening of the patient's condition with an increase in cough and one or more of dyspnoea, sputum volume or sputum purulence, necessitating a change in regular medication.
The primary objective of this study is to evaluate the effectiveness of standard care plus erdosteine in reducing hourly cough (24 hour cough recording using automated cough recorder) measured from baseline (Day 0) and at Day 5 of treatment, compared with standard care plus placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/females aged between 40-80 years
- •Previous diagnosis of COPD
- •Acute exacerbation of COPD requiring treatment with antibiotics and/or corticosteroids
- •Symptoms of increased breathlessness, cough, sputum volume or sputum purulence
- •Acute exacerbation of COPD hospitalised within 24hrs of study participation.
- •On a stable therapeutic regimen for COPD for 8 weeks prior to inclusion
- •Known history of cigarette smoking at least 10 pack yrs
- •Willing and able to comply with study procedures
- •Able to provide written informed consent to participate
排除标准
- •Acute exacerbation of COPD within 8 weeks prior to inclusion
- •Arterial blood gas on admission < pH 7.26
- •Currently on treatment with mucolytics
- •Patients suffering from post nasal drip, or gastro-oesophageal reflux disease
- •Clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus
- •On long-term oxygen therapy
- •Known or suspected hypersensitivity to erdosteine
研究组 & 干预措施
erdosteine
standard care plus erdosteine for 10 days
干预措施: Erdosteine (Drug)
placebo
Standard care for exacerbation of COPD plus placebo
干预措施: Placebo (Drug)
结局指标
主要结局
24 hr cough recording
时间窗: 5 days
The primary objective is to evaluate the effectiveness of standard care plus erdosteine in reducing hourly cough (24 hour cough recording using automated cough recorder) measureing differerrence in hourly cough rate from baseline (Day 0) and Day 5 of treatment, compared with standard care plus placebo
次要结局
- Quality of life questionnaire(10 days)