Effect of Azithromycin Maintenance Treatment on Infectious Exacerbations Among Patients With Non-Cystic Fibrosis Bronchiectasis The BAT Randomized Controlled Trial

Josje Altenburg*, Casper S. de Graaff, Ymkje Stienstra, Jacobus H. Sloos, Eric H. J. van Haren, Ralph J. H. Koppers, Tjip S. van der Werf, Wim G. Boersma

*Corresponding author for this work

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Abstract

Importance Macrolide antibiotics have been shown beneficial in cystic fibrosis (CF) and diffuse panbronchiolitis, and earlier findings also suggest a benefit in non-CF bronchiectasis.

Objective To determine the efficacy of macrolide maintenance treatment for adults with non-CF bronchiectasis.

Design, Setting, and Participants The BAT (Bronchiectasis and Long-term Azithromycin Treatment) study, a randomized, double-blind, placebo-controlled trial conducted between April 2008 and September 2010 in 14 hospitals in the Netherlands among 83 outpatients with non-CF bronchiectasis and 3 or more lower respiratory tract infections in the preceding year.

Interventions Azithromycin (250 mg daily) or placebo for 12 months.

Main Outcome Measures Number of infectious exacerbations during 12 months of treatment. Secondary end points included lung function, sputum bacteriology, inflammatory markers, adverse effects, symptom scores, and quality of life.

Results Forty-three participants (52%) received azithromycin and 40 (48%) received placebo and were included in the modified intention-to-treat analysis. At end of study, the median number of exacerbations in the azithromycin group was 0 (interquartile range [IQR], 0-1), compared with 2 (IQR, 1-3) in the placebo group (P

Conclusions and Relevance Among adults with non-CF bronchiectasis, the daily use of azithromycin for 12 months compared with placebo resulted in a lower rate of infectious exacerbations. This could result in better quality of life and might influence survival, although effects on antibiotic resistance need to be considered.

Original languageEnglish
Pages (from-to)1251-1259
Number of pages9
JournalJournal of the American Medical Association
Volume309
Issue number12
Publication statusPublished - 27-Mar-2013

Keywords

  • GEORGES RESPIRATORY QUESTIONNAIRE
  • PLACEBO-CONTROLLED TRIAL
  • LONG-TERM AZITHROMYCIN
  • LOW-DOSE AZITHROMYCIN
  • MACROLIDE RESISTANCE
  • DOUBLE-BLIND
  • PSEUDOMONAS-AERUGINOSA
  • STAPHYLOCOCCUS-AUREUS
  • PULMONARY-FUNCTION
  • HEALTH-STATUS

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