Bronchiectasis and Long Term Azithromycin Treatment
Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
Summary
1. SUMMARY
Rationale: Patients with bronchiectasis often experience lower respiratory tract infections
with progression of symptoms and decline in quality of life. Macrolides, as has been shown in
panbronchiolitis and cystic fibrosis, may break or weaken the link between infection and
inflammation resulting in an improvement of symptoms. Also the number of exacerbations may
lowered.
Objective: A reduction in number of infective exacerbations and improvement in lung function
by AZT treatment are the primary objectives. Secondary objectives that will be evaluated are:
symptoms score, quality of life, inflammatory parameters, bacterial colonisation, and adverse
events.
Study design: Randomised double blind multicenter study in the Netherlands. Patients will be
stratified for colonisation with P.aeruginosa.
Study population: Patients with bronchiectasis demonstrated by high-resolution computed
tomography (HR-CT) scan or bronchography.
Intervention: Patients receive Azithromycin 250mg(p.o.) once daily or placebo.
Main study parameters/endpoints: Reduction in number exacerbations, defined as increase
symptoms such as dyspnoea, coughing, and sputum production for which a course of prednisolone
and/or antibiotic is needed. Change in lung function parameters (forced expiratory volume in
1 second [FEV1], forced vital capacity [FVC]) measured by spirometry is the other primary
endpoint.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: The risk of participating in this study is low. Laboratory, radiographic
examinations, and pulmonary function tests are commonly used as diagnostic procedures during
outpatients visits and during exacerbations. Adverse effects in maintenance treatment with
AZT are usually mild and mainly gastrointestinal. Sometimes rash and abnormal liver function
tests are observed. A better quality of life will probably be the beneficial effect of long
term treatment with AZT. This will be achieved by a reduction in respiratory and
non-respiratory symptoms and number of exacerbations.