Abstract
Background: Primary Antibody Deficiencies (PAD) patients suffer from frequent respiratory infections leading to chronic pulmonary damage. Macrolides prophylaxis is effective to successfully manage chronic lung diseases as cystic fibrosis, bronchiectasis, COPD.
Aim: We conducted a trial to find out if low-dose azithromycin prophylaxis added to the usual care is effective and safe. Methods. A 3-year, phase II, prospective, multicenter, randomized, double-blind, placebo-controlled trial on adult PAD patients with chronic pulmonary disease. Patients received azithromycin 250 mg or placebo once daily three-times a week for 24 months. The primary outcome was the decrease of annual episodes of respiratory exacerbations. Secondary endpoints included: time to the first exacerbation, number of hospitalizations, additional doses of antibiotics, safety.
Results: Forty-four patients received azithromycin and 45 placebo. The mean number of exacerbations was 3·6 per patient-year in the azithromycin arm, and 5·2 in the placebo arm (p=0·02). In the azithromycin group the HR for having an acute exacerbation was 0·5 (p=0,03) and the HR for hospitalization was 0.5 (p=0·04). The rate of additional antibiotic treatment per patient-year was 2·3 in the intervention and 3·6 in placebo groups (p=0·004). Improvement in HRQofL was observed in intervention group. Azithromycin’s safety was comparable with placebo.
Conclusions: In PAD with respiratory exacerbation, azithromycin prophylaxis reduced exacerbation episodes, additional courses of antibiotics, and risk of hospitalization. It should be considered as a valuable option to add azithromycin to usual treatment.
Footnotes
Cite this article as: European Respiratory Journal 2019; 54: Suppl. 63, RCT5100.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
- Copyright ©the authors 2019