Contact information
Type
Scientific
Primary contact
Dr Brian Hunter Rowe
ORCID ID
Contact details
University of Alberta Hospital
Department of Emergency Medicine
8440 - 112 Street
1G1.42 WMC
Edmonton
T6G 2B7
Canada
+1 780 407 6707
brian.rowe@ualberta.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-63144
Study information
Scientific title
A randomised trial comparing clarithromycin to first-line antibiotics for the out-patient treatment of acute chronic obstructive pulmonary disease (COPD)
Acronym
COPD
Study hypothesis
Primary objectives:
To determine whether a 10-day course of oral antibiotics, given to patients with acute exacerbations of COPD on discharge from the emergency department will have an effect on the proportion of patients who relapse within 30 days of presentation.
Secondary objectives:
1. To determine whether the proportion of patients who relapse within 10 days will be lower in the macrolide-treated group
2. To determine whether macrolides will improve airflow obstruction (forced expiratory volume in one second [FEV1]) to a greater extent than placebo over the 30 day treatment period
3. To determine whether improvements in subjective dyspnoea scores and disease-specific, health-related quality of life will be greater in macrolide-treated patients
4. To determine whether macrolides will have an effect on the proportion of patients who require hospitalisation within 30 days of presentation
5. To compare rates of adverse effects among the macrolide and doxycycline groups.
Ethics approval
University of Alberta, Edmonton, Alberta, Health Research Ethics Board gave approval on 23rd May 2003
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Acute chronic obstructive pulmonary disease (COPD)
Intervention
All patients receive prednisone (40 mg/day x 10 days), Combivent inhaler, and an Aerochamber for inhaler delivery. Patients are randomised to receive clarithromycin (Biaxin- XL) or doxycycline in a double-blind, double dummy fashion.
Trial details received 12 Sept 2005
Intervention type
Drug
Phase
Not Applicable
Drug names
Clarithromycin, doxycycline
Primary outcome measure
The proportion of patients who relapse in the two treatments groups within 30 days of entry into the trial
Secondary outcome measures
1.The absolute and percent change in post-bronchodilator FEV1 on study day 10 and day 30 compared to day 1
2. Improvement in subjective dyspnoea score as assessed by the baseline and transitional Dyspnoea Indexes
3. Improvement in disease-specific quality of life as assessed by the Chronic Respiratory Disease Index Questionnaire (CRQ)
4. Proportion of patients hospitalised (and their length of stay data) within 30 days
5. Adverse effect rates assessed at 10 days
Overall trial start date
01/11/2003
Overall trial end date
30/04/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
270
Participant 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
Recruitment start date
01/11/2003
Recruitment end date
30/04/2006
Locations
Countries of recruitment
Canada
Trial participating centre
University of Alberta Hospital
Edmonton
T6G 2B7
Canada
Sponsor information
Organisation
University of Alberta (Canada) - Faculty of Medicine and Dentistry
Sponsor details
8440 - 112 Street
Edmonton
T6G 2B7
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63144)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Abbott (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Boehringer-Ingelheim (USA)
Alternative name(s)
Boehringer Ingelheim Pharmaceuticals, Inc., BI, BIPI
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. Abstract presented at Canadian Association of Emergency Physicians (CAEP)/ACMU, Victoria, June 2007:
Rowe BH, Aaron SD, Abu-Laban R, Stiell IG, Johnson J, Sivilotti M, Campbell S, Mackey D, Young B, Ross S, Walker A, Worster A, Sentilselvan A. Antibiotic selection reduces relapse following Emergency Department discharge in patients with exacerbations of chronic obstructive pulmonary disease. Can J Emerg Med. 2007; 9:184.
2. Abstract presented at the Society for Academic Emergency Medicine, Washington, DC, May 2008:
Rowe B, Aaron S, Abu-Laban R, Stiell IG, Johnson J, Sivilotti M, Campbell S, Mackey D, Worster A, Ross S, Young B, Walker A, Marrie T, Senthilselvan A. Antibiotic selection reduces relapse following Emergency Department discharge in patients with exacerbations of chronic obstructive pulmonary disease. Acad Emerg Med 2008;15(5)S13.