A randomised trial comparing clarithromycin to first-line antibiotics for the out-patient treatment of acute chronic obstructive pulmonary disease (COPD)

niversity of Alberta (Canada) - Faculty of Medicine and Dentistry0 个研究点目标入组 270 人开始时间: 2005年11月18日最近更新: 2015年1月13日

适应症

试验速览

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•1. Patients must have had a previous diagnosis of chronic bronchitis, emphysema or COPD established by their physician
•2. Patients must have evidence of airflow obstruction on presentation at the emergency department, defined as an FEV1 less than or equal to 70% of predicted and a FEV1/forced vital capacity (FVC) ratio less than or equal to 70%
•3. Patient must be greater than or equal to 35 years old, either sex
•4. Patients must have a minimum history of 15 pack-years of smoking
•5. Patients must be experiencing an acute exacerbation of COPD and must meet at least two of the following three clinical criteria for acute COPD exacerbation as defined by Anthonisen: increased chronic baseline dyspnoea, increased sputum volume or increased sputum purulence. The above complaints had to have necessitated the ED visit.

•1. Physician diagnosed asthma (before age 40)
•2. Use of oral or injectable antibiotics during the 10 days preceding trial entry
•3. Patients with a history of bronchiectasis or cystic fibrosis will be excluded
•4. Pneumonia or congestive heart failure on emergency room chest radiography
•5. Patients not able to perform spirometry assessment
•6. Patients with known adverse reaction or intolerance to macrolides or doxycycline
•7. Inability to provide informed consent or comply with the study protocol due to cognitive impairment, language barrier, or distance greater than 100 km from the study centre
•8. Patients admitted to hospital
•9. Patients has previously participated in the study

发起方

niversity of Alberta (Canada) - Faculty of Medicine and Dentistry