Condition category
Respiratory
Date applied
18/11/2005
Date assigned
18/11/2005
Last edited
03/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.med.ualberta.ca/Home/index.cfm

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, Boehringer Ingelheim Pharmaceuticals, Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results - basic reporting

Publication summary

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.

Publication citations

Additional files

Editorial Notes