Study Results
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Basic Information
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COMPLETED
PHASE3
72 participants
INTERVENTIONAL
2008-04-30
2010-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Azithromycin treatment 1
Azithromycin
Azithromycin Tablet 250 mg daily
Placebo 2
Placebo
Placebo tablet 1 daily
Interventions
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Azithromycin
Azithromycin Tablet 250 mg daily
Placebo
Placebo tablet 1 daily
Eligibility Criteria
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Inclusion Criteria
* Bronchiectasis diagnosed by plain bronchography or high resolution computer tomography.
* Minimal 3 lower respiratory tract infections (LRTI) treated with oral/intravenous (IV) antibiotics in the year preceding the study inclusion.
* The presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum.
* At least one positive sputum culture in the preceding year.
* Informed consent
Exclusion Criteria
* Pregnant or lactating women.
* Allergy to macrolides.
* Intolerance to macrolides.
* Liver disease (alanine transaminase and/or aspartate transaminase levels 2 or more times the upper limit of normal).
* Use of antibiotics within 14 days of screening.
* Use of oral or IV corticosteroids (≥ 30 mg prednisolone/daily) within 30 days of screening.
* Other research medication started 2 months prior to inclusion.
18 Years
ALL
Yes
Sponsors
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W.G.Boersma
OTHER
Responsible Party
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W.G.Boersma
Doctor, MD
Principal Investigators
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W.G. Boersma, MD,PHD
Role: STUDY_DIRECTOR
Medical Center Alkmaar, dep. Pulmomary Diseases
Locations
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Alkmaar Medical Center
Alkmaar, N-H, Netherlands
AMC
Amsterdam, , Netherlands
St Lucas Andreas Ziekenhuis
Amsterdam, , Netherlands
Rode Kruis Ziekenhuis
Beverwijk, , Netherlands
Deventer Ziekenhuis
Deventer, , Netherlands
U.L.C. Dekkerswald
Groesbeek, , Netherlands
University Hospital Groningen (UMCG)
Groningen, , Netherlands
Atrium Medisch Centrum
Heerlen, , Netherlands
Tergooi Ziekenhuizen
Hilversum, , Netherlands
Spaarne Ziekenhuis
Hoofddorp, , Netherlands
MC Leeuwarden
Leeuwarden, , Netherlands
Antonius Ziekenhuis
Nieuwegein, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Diakonessenhuis
Utrecht, , Netherlands
Viecuri MC
Venlo, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
Countries
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References
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Terpstra LC, Altenburg J, Mohamed Hoesein FA, Bronsveld I, Go S, van Rijn PAC, De Jong PA, Heijerman HGM, Boersma WG. The effect of maintenance azithromycin on radiological features in patients with bronchiectasis - Analysis from the BAT randomized controlled trial. Respir Med. 2022 Feb;192:106718. doi: 10.1016/j.rmed.2021.106718. Epub 2021 Dec 28.
Altenburg J, de Graaff CS, Stienstra Y, Sloos JH, van Haren EH, Koppers RJ, van der Werf TS, Boersma WG. Effect of azithromycin maintenance treatment on infectious exacerbations among patients with non-cystic fibrosis bronchiectasis: the BAT randomized controlled trial. JAMA. 2013 Mar 27;309(12):1251-9. doi: 10.1001/jama.2013.1937.
Other Identifiers
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BAT-2006
Identifier Type: -
Identifier Source: secondary_id
BAT-2006-MCA1
Identifier Type: -
Identifier Source: org_study_id
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