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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

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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.
Keywords
azithromycin, physical activity, macrolide antibiotics, acute exacerbation, COPD, RCT, OBSTRUCTIVE PULMONARY-DISEASE, PREVENTION, TERM, PHARMACOKINETICS, METAANALYSIS, ANTIBIOTICS, METHODOLOGY, REJECTION, DESIGN

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Chicago
Vermeersch, Kristina, Maria Gabrovska, Griet Deslypere, Ingel K Demedts, Hans Slabbynck, Joseph Aumann, Vincent Ninane, et al. 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.” International Journal of Chronic Obstructive Pulmonary Disease 11: 687–696.
APA
Vermeersch, K., Gabrovska, M., Deslypere, G., Demedts, I. K., Slabbynck, H., Aumann, J., Ninane, V., et al. (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. INTERNATIONAL JOURNAL OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE, 11, 687–696.
Vancouver
1.
Vermeersch K, Gabrovska M, Deslypere G, Demedts IK, Slabbynck H, Aumann J, et al. 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. INTERNATIONAL JOURNAL OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE. 2016;11:687–96.
MLA
Vermeersch, Kristina et al. “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.” INTERNATIONAL JOURNAL OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE 11 (2016): 687–696. Print.
@article{8037326,
  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.},
  author       = {Vermeersch, Kristina and Gabrovska, Maria and Deslypere, Griet and Demedts, Ingel K and Slabbynck, Hans and Aumann, Joseph and Ninane, Vincent and Verleden, Geert M and Troosters, Thierry and Bogaerts, Kris and Brusselle, Guy and Janssens, Wim},
  issn         = {1178-2005},
  journal      = {INTERNATIONAL JOURNAL OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE},
  keywords     = {azithromycin,physical activity,macrolide antibiotics,acute exacerbation,COPD,RCT,OBSTRUCTIVE PULMONARY-DISEASE,PREVENTION,TERM,PHARMACOKINETICS,METAANALYSIS,ANTIBIOTICS,METHODOLOGY,REJECTION,DESIGN},
  language     = {eng},
  pages        = {687--696},
  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},
  url          = {http://dx.doi.org/10.2147/COPD.S95501},
  volume       = {11},
  year         = {2016},
}

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