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dc.contributor.authorVermeersch, Kristina-
dc.contributor.authorGabrovska, Maria-
dc.contributor.authorDeslypere, Griet-
dc.contributor.authorDemedts, Ingel K.-
dc.contributor.authorSlabbynck, Hans-
dc.contributor.authorAUMANN, Joseph-
dc.contributor.authorNinane, Vincent-
dc.contributor.authorVerleden, Geert M.-
dc.contributor.authorTroosters, Thierry-
dc.contributor.authorBOGAERTS, Kris-
dc.contributor.authorBrusselle, Guy G.-
dc.contributor.authorJANSSENS, Wim-
dc.identifier.citationInternational Journal of Chronic Obstructive Pulmonary Disease, 11, p. 687-696-
dc.description.abstractBackground: 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.-
dc.description.sponsorshipThe BACE trial is funded by a grant from the Agentschap voor Innovatie door Wetenschap en Technologie (IWT) through the Toegepast Biomedisch onderzoek meteen primair Maatschappelijke finaliteit (TBM) program: IWT-TBM number: 130233. KV is supported by the IWT. Financial support for study logistics is also received from Teva Pharma Belgium. Neither IWT nor Teva Pharma Belgium is involved in the study design, in the collection, analysis, and interpretation of data, in the writing of the manuscript, or in the decision to submit the manuscript for publication. The trial is also approved and supported by the Belgian Thoracic Society which provided logistic support for the organization of the investigators' meetings. Special thanks goes to the Clinical Trial Center of UZ Leuven and the contract unit of KU Leuven Research and Development in supporting the financial contracts and legal aspects of the trial organization. Finally, the BACE trial investigators are acknowledged for their participation and the inclusion of the study patients: Vincent Ninane (CHU Saint-Pierre, Brussels, Belgium), Joseph Aumann (Jessa Ziekenhuis, Hasselt, Belgium), Ingel K Demedts (AZ Delta Roeselare-Menen, Roeselare, Belgium), Hans Slabbynck (ZNA Middelheim, Antwerpen, Belgium), Eric Marchand (CHU de Mont-Godinne, Yvoir, Belgium), Christel Haenebalcke (AZ Sint-Jan, Brugge-Oostende, Belgium), Rudi pech, (CHU de Charleroi, Charleroi, Belgium), Guy G Brusselle (UZ Gent, Gent, Belgium), Walter Vincken and Shane Hanon (UZ Brussel, Brussels, Belgium), Jean-Louis Corhay (CHU de Liege, Luik, Belgium), Michiel Haerens (AZ Groeninge, Kortrijk, Belgium), Antoine Fremault (Grand Hopital de Charleroi, Charleroi, Belgium), Tine Lauwerier (Imeldaziekenhuis, Bonheiden, Belgium), Alix Debrock (Sint Augustinus Ziekenhuis, Antwerpen, Belgium), Jan Lamont (Maria Middelares Ziekenhuis, Gent, Belgium), Geert Tits (Sint-Andriesziekenhuis, Tielt, Belgium), Paul Jordens (Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium), Alain Delobbe (Clinique Reine Astrid, Malmedy, Belgium), Jean-Benoit Martinot (Clinique Sainte-Elisabeth, Namur, Belgium).-
dc.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 (
dc.subject.otherCOPD; acute exacerbation; macrolide antibiotics; azithromycin; physical activity; RCT-
dc.subject.otherCOPD; acute exacerbation; macrolide antibiotics; azithromycin; physical activity; RCT-
dc.titleThe Belgian trial with azithromycin for acute COPD exacerbations requiring hospitalization: an investigator-initiated study protocol for a multicenter, randomized, double-blind, placebo-controlled trial-
dc.typeJournal Contribution-
dc.description.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.-
item.validationecoom 2017-
item.fulltextWith Fulltext-
item.accessRightsOpen Access-
item.fullcitationVermeersch, Kristina; Gabrovska, Maria; Deslypere, Griet; Demedts, Ingel K.; Slabbynck, Hans; AUMANN, Joseph; Ninane, Vincent; Verleden, Geert M.; Troosters, Thierry; BOGAERTS, Kris; Brusselle, Guy G. & JANSSENS, Wim (2016) 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. In: International Journal of Chronic Obstructive Pulmonary Disease, 11, p. 687-696.-
item.contributorNinane, Vincent-
item.contributorVermeersch, Kristina-
item.contributorDemedts, Ingel K.-
item.contributorAUMANN, Joseph-
item.contributorVerleden, Geert M.-
item.contributorBOGAERTS, Kris-
item.contributorJANSSENS, Wim-
item.contributorSlabbynck, Hans-
item.contributorTroosters, Thierry-
item.contributorBrusselle, Guy G.-
item.contributorGabrovska, Maria-
item.contributorDeslypere, Griet-
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