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Trial registered on ANZCTR


Trial ID
ACTRN12605000229673
Ethics application status
Approved
Date submitted
25/08/2005
Date registered
26/08/2005
Date last updated
19/03/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Long term use of azithromycin for chronic lung disease in Aboriginal adults: a randomised controlled trial.
Scientific title
A triple-blind, placebo controlled clinical trial which is designed to determine whether a weekly dose of 1 gram oral azithromycin for one year will reduce acute infective exacerbations in adult Aboriginal Australians adults with chronic obstructive pulmonary disease (COPD).
Secondary ID [1] 123 0
R107
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 315 0
Condition category
Condition code
Respiratory 359 359 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a multi-centre, triple-blind, placebo controlled clinical trial which is designed to determine whether a weekly dose of 1 gram oral azithromycin given for one year will reduce the frequency and severity of acute exacerbations in Northern Territory Aboriginal adults with a diagnosis of chronic obstructive pulmonary disease (COPD).
Intervention code [1] 258 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 418 0
Self-reported acute exacerbations of COPD as defined as two of either:increasing cough with sputum production, change in colour of sputum, increasing dyspnoea.
Timepoint [1] 418 0
An interim analysis at 6 months and final analysis at 12 months.
Primary outcome [2] 419 0
Numbers presenting to a health care provider for respiratory disease.
Timepoint [2] 419 0
An interim analysis at 6 months and final analysis at 12 months.
Secondary outcome [1] 891 0
1. Acute exacerbation: proportion admitted to hospital with a separation diagnosis of COPD or pneumonia.
Timepoint [1] 891 0
Secondary outcome [2] 892 0
2. Acute exacerbation: proportion with increased use of bronchodilators.
Timepoint [2] 892 0
Secondary outcome [3] 893 0
3. Rate of decline of lung function: FEV1, FEV1/FVC ratio.
Timepoint [3] 893 0
Secondary outcome [4] 894 0
4. Markers of airway inflammation: difference in mean concentration of cytokines.
Timepoint [4] 894 0
Secondary outcome [5] 895 0
5. Antibiotic resistance: proportion with carriage of resistant bacterial pathogens.
Timepoint [5] 895 0
Secondary outcome [6] 896 0
6. Respiratory pathogen loads: Proportion with respiratory pathogens and subtypes isolated.
Timepoint [6] 896 0
Secondary outcome [7] 897 0
7. Self assessed health status: proportion with different levels of self-assessed health status.
Timepoint [7] 897 0
Secondary outcome [8] 898 0
8. Side effects: proportion of reported side effects, proportion withdrawn from the study due to side effects, proportion with health service utilisation due to side effects.
Timepoint [8] 898 0
Secondary outcome [9] 899 0
9. BMI and percent body fat: difference in mean BMI and percent body fat.
Timepoint [9] 899 0
Secondary outcome [10] 900 0
10. Compliance with medication: difference in compliance during treatment.
Timepoint [10] 900 0

Eligibility
Key inclusion criteria
Informed consent- Indigenous Australian. COPD as defined: FEV1<75% predicted and FEV1/FVC<70%, AND <15%improvement in FEV1 following administration of bronchodilators as determined by spirometry before and 10minutes after inhaling 200mcg of salbutamol from a metered dose inhaler, AND chronic cough and sputum production on most days for greater than one year.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women, women intending to become pregnant during the course of the study and lactating women.- People participating in any other study of antibiotics or vaccines.- People already on long term antibiotics- People allergic to the macrolide antibiotics - Evidence of bronchiectasis on chest X ray- People with other serious illnesses, which make them unsuitable for the study, ie. Severe heart or kidney disease.- Inability to perform adequate spirometry- Those who are unlikely to be available for the duration of the trial, for example; those who also live at an outstation or another community.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequence will be concealed until interventions are assigned and will be allocated by a person independent to the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The block randomisation sequence will be generated by the Computer and Statistics Unit at Menzies School of Health Research using the Stata - RALLOC computer program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 418 0
Government body
Name [1] 418 0
National Health and Medical Research Council
Address [1] 418 0
Country [1] 418 0
Australia
Funding source category [2] 419 0
Other Collaborative groups
Name [2] 419 0
Cooperative Research Centre for Aboriginal Health
Address [2] 419 0
Country [2] 419 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Menzies School of Health Research
Address
Country
Australia
Secondary sponsor category [1] 338 0
None
Name [1] 338 0
Nil
Address [1] 338 0
Country [1] 338 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The study is designed to determine whether an antibiotic called azithromycin (1gram dose) given once a week for a year will reduce the number of chest infections, the severity of these chest infections and decrease the damage these chest infections are doing to the lungs of Aboriginal adults with lung disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35960 0
Address 35960 0
Country 35960 0
Phone 35960 0
Fax 35960 0
Email 35960 0
Contact person for public queries
Name 9447 0
Maria Tchan
Address 9447 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
Country 9447 0
Australia
Phone 9447 0
+61 8 89228598
Fax 9447 0
+61 8 89227876
Email 9447 0
maria.tchan@menizes.edu.au
Contact person for scientific queries
Name 375 0
Dr Graeme Maguire
Address 375 0
Western Australia Country Health Service (WACHS)
Locked Bag 4011
Broome WA 6725
Country 375 0
Australia
Phone 375 0
+61 8 91941624
Fax 375 0
+61 8 91941622
Email 375 0
graeme.maguire@health.wa.gov.au