Calrithromycin versus first-line antibiotics for acute chronic obstructive pulmonary disease (COPD)

Completed

Conditions: Acute chronic obstructive pulmonary disease (COPD)
Respiratory
Other chronic obstructive pulmonary disease

Registration Number: ISRCTN03714514

Lead Sponsor: niversity of Alberta (Canada) - Faculty of Medicine and Dentistry

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 270

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients who relapse in the two treatments groups within 30 days of entry into the trial

Secondary Outcome Measures

Name	Time	Method
1.The absolute and percent change in post-bronchodilator FEV1 on study day 10 and day 30 compared to day 1 <br>2. Improvement in subjective dyspnoea score as assessed by the baseline and transitional Dyspnoea Indexes<br>3. Improvement in disease-specific quality of life as assessed by the Chronic Respiratory Disease Index Questionnaire (CRQ)<br>4. Proportion of patients hospitalised (and their length of stay data) within 30 days<br>5. Adverse effect rates assessed at 10 days