RecruitingPhase 3ACTRN12605000229673

Long term use of azithromycin for chronic lung disease in Aboriginal adults: a randomised controlled trial.

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).

Sponsor

Menzies School of Health Research

Enrollment

130 participants

Start Date

Apr 10, 2005

Study Type

Interventional

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

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.

Exclusion Criteria1

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.

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Interventions

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).