Long term azithromycin treatment: A randomised placebo-controlled trial in non-CF bronchiectasis; results from the BAT trial

Introduction: Bronchiectasis arises from an ongoing cycle of inflammation and bacterial colonization and has a major impact on a patient9s wellbeing, mainly because of frequent infectious exacerbations. Aim: Assessing the efficacy of longterm azithromycin treament over 1 year in patients with non-cystic fibrosis bronchiectasis in a randomized placebo controlled trial. Methods: 89 patients from 14 sites were randomized to either azithromycin 250 mg daily or placebo, for 12 months. All were reviewed at three-monthly intervals during treatment and at 3 month9s follow-up. At each review the following were assessed; exacerbation frequency (being the primary endpoint), lung function, qualitative and quantitative sputum bacteriology, serum and sputum inflammatory markers, adverse effects, symptom scores and St George9s respiratory questionnaire. High resolution CT-scans were performed at study entrance and end of study. Primary results: 81 patients completed the study. At the end of 12 month9s treatment the azithromycin group showed a significant reduction in exacerbation frequency as compared to the placebo treated group (1,28/year, SD 1,32 vs 2,67/year, SD 1,95, p Conclusions: Longterm azithromycin treatment significantly reduces exacerbation frequency in patients with non-CF bronchiectasis, without additional side effects.