6/27/23, 11:42 PM BAT Pathway Feedback Search Clinical Topics Home Studies BAT BAT Disease Bronchiectasis Trial question What is the role of azithromycin maintenance treatment on infectious exacerbations in adult patients with non-cystic fibrosis bronchiectasis? Study design Multi-center Double blinded RCT Population Characteristics of study participants 64.0% female N = 83 36.0% male 83 patients (53 female, 30 male) Inclusion criteria: adult patients with non-cystic fibrosis bronchiectasis and 3 lower respiratory tract infections in the preceding year Key exclusion criteria: prolonged (> 4 weeks) macrolide therapy during the previous 3 months, oral or intravenous courses of corticosteroids within 30 days of screening, any antimicrobial treatment for an LRTI in the last 2 weeks, known allergy or intolerance to macrolides, or patients with liver disease Interventions N=43 azithromycin (250 mg daily for 12 months) N=40 placebo (matching placebo daily for 12 months) Primary outcome Exacerbation, at least 1 https://web.pathway.md/studies/rectmdCVACPCmmUcP 1/2 6/27/23, 11:42 PM BAT Pathway 80.0 % 80 60.0 % 46 40.0 % 20.0 % Borderline significant decrease 0.0 % Azithromycin Placebo Borderline significant decrease in exacerbation, at least 1 (46% vs. 80%; HR 0.29, 95% CI 0.16 to 0.51) Safety outcomes Significant differences in gastrointestinal adverse effects (40% vs 5%), including abdominal pain (19% vs. 3%) and diarrhea (21% vs. 3%) and macrolide resistance (88% vs. 26%). Conclusion In adult patients with non-cystic fibrosis bronchiectasis and 3 lower respiratory tract infections in the preceding year, azithromycin was superior to placebo with respect to exacerbation, at least 1. Reference Altenburg J, de Graaff CS, Stienstra Y et al. Effect of azithromycin maintenance treatment on infectious exacerbations among patients with non-cystic fibrosis bronchiectasis: the BAT randomized controlled trial. JAMA. 2013 Mar 27;309(12):1251-9. Open reference URL https://web.pathway.md/studies/rectmdCVACPCmmUcP 2/2