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Title: The Belgian trial with azithromycin for acute COPD exacerbations requiring hospitalization: an investigator-initiated study protocol for a multicenter, randomized, double-blind, placebo-controlled trial
Authors: Vermeersch, Kristina
Gabrovska, Maria
Deslypere, Griet
Demedts, Ingel K.
Slabbynck, Hans
AUMANN, Joseph 
Ninane, Vincent
Verleden, Geert M.
Troosters, Thierry
Brusselle, Guy G.
Issue Date: 2016
Source: International Journal of Chronic Obstructive Pulmonary Disease, 11, p. 687-696
Abstract: Background: Long-term use of macrolide antibiotics is effective to prevent exacerbations in chronic obstructive pulmonary disease (COPD). As risks and side effects of long-term intervention outweigh the benefits in the general COPD population, the optimal dose, duration of treatment, and target population are yet to be defined. Hospitalization for an acute exacerbation (AE) of COPD may offer a targeted risk group and an obvious risk period for studying macrolide interventions. Methods/design: Patients with COPD, hospitalized for an AE, who have a smoking history of > 10 pack-years and had > 1 exacerbation in the previous year will be enrolled in a multicenter, randomized, double-blind, placebo-controlled trial (NCT02135354). On top of a standardized treatment of systemic corticosteroids and antibiotics, subjects will be randomized to receive either azithromycin or placebo during 3 months, at an uploading dose of 500 mg once a day for 3 days, followed by a maintenance dose of 250 mg once every 2 days. The primary endpoint is the time-to-treatment failure during the treatment phase (ie, from the moment of randomization until the end of intervention). Treatment failure is a novel composite endpoint defined as either death, the admission to intensive care or the requirement of additional systemic steroids or new antibiotics for respiratory reasons, or the diagnosis of a new AE after discharge. Discussion: We investigate whether azithromycin initiated at the onset of a severe exacerbation, with a limited duration and at a low dose, might be effective and safe in the highest risk period during and immediately after the acute event. If proven effective and safe, this targeted approach may improve the treatment of severe AEs and redirect the preventive use of azithromycin in COPD to a temporary intervention in the subgroup with the highest unmet needs.
Notes: [Vermeersch, Kristina; Verleden, Geert M.; Troosters, Thierry; Janssens, Wim] Katholieke Univ Leuven, Fac Med, Dept Clin & Expt Med, Lab Resp Dis, Herestr 49,O&NI,Box 706, B-3000 Leuven, Belgium. [Gabrovska, Maria; Ninane, Vincent] Ctr Hosp Univ St Pierre, Dept Pneumol, Brussels, Belgium. [Deslypere, Griet; Aumann, Joseph] Jessa Ziekenhuis, Dept Pneumol, Hasselt, Belgium. [Demedts, Ingel K.] AZ Delta Roeselare Menen, Dept Resp Med, Roeselare, Belgium. [Slabbynck, Hans] ZNA Middelheim, Dept Resp Med, Antwerp, Belgium. [Troosters, Thierry] Katholieke Univ Leuven, Fac Kinesiol & Rehabil Sci, Dept Rehabil Sci, Herestr 49,O&NI,Box 706, B-3000 Leuven, Belgium. [Bogaerts, Kris] Katholieke Univ Leuven, Dept Publ Hlth & Primary Care, I BioStat, Herestr 49,O&NI,Box 706, B-3000 Leuven, Belgium. [Bogaerts, Kris] Hasselt Univ, Hasselt, Belgium. [Janssens, Wim] Ghent Univ Hosp, Dept Resp Med, Ghent, Belgium.
Keywords: COPD; acute exacerbation; macrolide antibiotics; azithromycin; physical activity; RCT;COPD; acute exacerbation; macrolide antibiotics; azithromycin; physical activity; RCT
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ISSN: 1178-2005
e-ISSN: 1178-2005
DOI: 10.2147/COPD.S95501
ISI #: 000373053200001
Rights: © 2016 Vermeersch et al. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (
Category: A1
Type: Journal Contribution
Validations: ecoom 2017
Appears in Collections:Research publications

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