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

ISRCTN	ISRCTN03714514
DOI	https://doi.org/10.1186/ISRCTN03714514
Secondary identifying numbers	MCT-63144

Submission date: 18/11/2005
Registration date: 18/11/2005
Last edited: 03/03/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Brian Hunter Rowe
Scientific

University of Alberta Hospital
Department of Emergency Medicine
8440 - 112 Street
1G1.42 WMC
Edmonton
T6G 2B7
Canada

Phone	+1 780 407 6707
Email	brian.rowe@ualberta.ca

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A randomised trial comparing clarithromycin to first-line antibiotics for the out-patient treatment of acute chronic obstructive pulmonary disease (COPD)
Study acronym	COPD
Study objectives	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(s)	University of Alberta, Edmonton, Alberta, Health Research Ethics Board gave approval on 23rd May 2003
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/11/2003
Completion date	30/04/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	270
Key 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.
Key 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
Date of first enrolment	01/11/2003
Date of final enrolment	30/04/2006

Locations

Countries of recruitment

Canada

Study participating centre

University of Alberta Hospital

Edmonton
T6G 2B7
Canada

Sponsor information

University of Alberta (Canada) - Faculty of Medicine and Dentistry
University/education

8440 - 112 Street
Edmonton
T6G 2B7
Canada

Website	http://www.med.ualberta.ca/Home/index.cfm
"ROR"	https://ror.org/0160cpw27

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63144)

No information available

Abbott (USA)

No information available

Boehringer-Ingelheim (USA)
Private sector organisation / For-profit companies (industry)

Alternative name(s): Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, BI, BIPI
Location: United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	p184	01/05/2007		No	No
Abstract results	S13	01/05/2008		No	No