Phase III (c) The Effect of Azithromycin in Patients With COPD and Chronic Productive Cough
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Isala
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Mean change in the Leicester Cough Questionnaire (LCQ) scores.
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy of azithromycin to produce a significant change in the cough-related health status, measured with the Dutch version of the Leicester Cough Questionnaire in patiënts with COPD gold classification 2-4 and chronic productive coughing.
详细描述
This study is a prospective double-centre, double blind randomised trial. Patients > 40 years of age, referred to our outpatient clinic with chronic cough and sputum production due to COPD will be recruited after informed consent is obtained.
Consenting patients will be randomises to a 12-week treatment with 250 mg azithromycin three times a week or placebo.
Before randomisation all patients have to fill in the SF 36 , SGRQ and the Dutch version of the Leicester Cough Questionnaire (LCQ) for assessment of the baseline quality of life and the disease specific quality of life.
The LCQ questionnaires will be performed at the beginning and every 3 weeks afterwards until 18 weeks, except the second LCQ which will be filled in after 2 weeks. Scores from this questionnaire will be used to calculate the 2-week repeatability. The SF 36 and SGRQ will be performed at the start of the study and after 12 weeks. Adverse events will be recorded during the whole treatment period. After 2 and 12 weeks a Global Rating of Change will be performed. This questionnaire will be used to validate the LCQ in COPD patients.
Randomisation will take place using a computer allocation program (BAMI-computer)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 40 years of age, in our outpatient clinic with chronic cough and COPD (gold2-4)
- •Chronic cough is defined as a cough > 12 weeks duration, at least 12 weeks a year in 2 subsequent years.
- •Analysed for bronchiectasis prior to participation by CT-thorax.
排除标准
- •Prior history of asthma
- •Use of i.v. or oral corticosteroids and or antibiotics for an exacerbation 3 weeks before inclusion
- •Patients suffering from other relevant lung diseases.
- •Clinically relevant abnormal laboratory values suggesting an unknown disease requiring further clinical evaluation.
- •Liver disease, (ALAT and/or ASAT levels two or more times the upper limit of normal).
- •Pregnancy or lactation.
- •Use of macrolides the last 6 weeks prior to inclusion.
- •Allergy or intolerance to macrolides.
- •Other research medication started 2 months prior to inclusion.
- •Prior randomisation in this study.
研究组 & 干预措施
Azithromycin
干预措施: azithromycin (Drug)
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Mean change in the Leicester Cough Questionnaire (LCQ) scores.
时间窗: 2 years
次要结局
- Mean change in the SF 36 and SGRQ scores.(2 years)
- Change in lung function, (FEV1 (L) and FVC (L)).(2 years)
- Adverse reactions.(2 years)
- Laboratory values: CRP, ASAT, ALAT(2 years)
- Sputum analysis(2 years)
- Number of exacerbations.(2 years)