Bronchiectasis and Long Term Azithromycin Treatment (BAT)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Bronchiectasis and Long Term Azithromycin Treatment: A Randomised Placebo-controlled Trial Studying Disease Modifying Effects of Immunomodulating Treatment|
- Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Is there any improvement in symptom score during treatment with AZM? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- What is the effect of AZM on bacterial colonisation? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Does treatment with AZM reduce inflammatory parameters? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Does treatment with AZM change the quality of life? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Is there any differences in adverse events between AZM and placebo treatment? [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: Azithromycin treatment 1||
Azithromycin Tablet 250 mg daily
|Placebo Comparator: Placebo 2||
Placebo tablet 1 daily
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415350
|Alkmaar Medical Center|
|Alkmaar, N-H, Netherlands, 1800AM|
|St Lucas Andreas Ziekenhuis|
|Rode Kruis Ziekenhuis|
|University Hospital Groningen (UMCG)|
|Atrium Medisch Centrum|
|Erasmus Medical Center|
|Study Director:||W.G. Boersma, MD,PHD||Medical Center Alkmaar, dep. Pulmomary Diseases|