Antibiotic in non-purulent hospitalised-treated exacerbations of COPD: a randomised double-blind placebo-controlled trial

Prescription of antibiotics is wide and generalised in COPD exacerbated patients requiring hospitalisation. Previous data showed that sputum purulence-guided antibiotic treatment strategy might be useful in severe exacerbations. The aim of this study was to investigate the non-inferiority of placebo compared to antibiotic treatment in non-purulent severe exacerbations of COPD. Methods: In this RCT, we recruited a cohort of patients with non-purulent severe exacerbation of COPD. We randomly assigned them to a 5-day course of oral moxifloxacin (400 mg daily) or placebo. The primary outcome was the rate of treatment failure on day 3. Findings: We randomly allocated 73 (25%) patients from the total cohort of 287 evaluated patients with non-purulent exacerbations, and 72 were included in the ITT analysis (35 in the placebo arm and 37 in the moxifloxacin arm). For the primary outcome, 4 patients (11%) in the placebo group and 3 patients (8%) in the moxifloxacin group presented treatment failure (difference 3%, p =0.71; 2-sided 95% CI -0.10-0.17) not reaching the pre-specified non-inferiority failure limit of 15%. We did not observe significant differences between groups in length of stay (LOS) median 6 days (IQR 4-7) in placebo group vs 5 days (IQR 4-7) in moxifloxacin group. Interpretation: In patients with COPD requiring hospitalisation for non-purulent exacerbation, treatment without antibiotic was not inferior to antibiotics in treatment failure or LOS.