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SETTING 13 primary care centers in Catalonia, Spain.
PATIENTS 318 outpatients ≥ 40 years of age (mean age 68 y, 81% men) who had an exacerbation (≥ 1 of increased dyspnea, increased sputum volume, or sputum purulence) of mild-to-moderate COPD (≥ 10 pack-y smoking history, postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 > 50% of predicted value). Exclusion criteria included need for hospitalization; antibiotic use in the past 2 weeks; hypersensitivity to β-lactams, clavulanate, or lactose; immunosuppression; bronchial asthma; cystic fibrosis; active neoplasm; bronchiectasis due to conditions other than COPD; or tracheotomy.

INTERVENTION Amoxicillin/clavulanate, 500/125 mg (n = 162), or placebo (n = 156), 3 times/d for 8 days. Oral corticosteroids (≤ 60 mg/d) for ≤ 10 days could be used in both groups.

OUTCOMES Primary outcome was clinical cure (disappearance of infection-related acute signs and symptoms and return to stability) at 9 to 11 days. Other outcomes included clinical success (cure or improvement [incomplete symptom resolution without need for another medication or intervention]) and time to next exacerbation.

PATIENT FOLLOW-UP 97% (intention-to-treat analysis).

MAIN RESULTS Oral corticosteroids were used in 16% of patients in the amoxicillin group and 18% in the placebo group. Amoxicillin/clavulanate increased clinical cure and clinical success rates at 9 to 11 days and at 20 days compared with placebo (Table). Time to next exacerbation was longer with amoxicillin/clavulanate than with placebo (median 233 vs 160 d, P = 0.015).

CONCLUSION Amoxicillin/clavulanate improved clinical cure rate and increased time to next exacerbation compared with placebo in patients with moderate exacerbation of mild-to-moderate chronic obstructive pulmonary disease.Amoxicillin/clavulanate (AMX) vs placebo for moderate exacerbations of mild-to-moderate chronic obstructive pulmonary disease‡OutcomesAMXPlaceboRBI (95% CI)NNT (CI)Clinical cure§ at 9 to 11 d74%60%24% (6 to 46)8 (5 to 27)Clinical success|| at 9 to 11 d91%81%12% (2 to 24)11 (6 to 55)Clinical cure§ at 20 d82%68%20% (6 to 38)8 (5 to 24)Clinical success|| at 20 d91%80%13% (3 to 25)10 (6 to 41)‡Abbreviations defined in Glossary. RBI, NNT, and CI calculated from event rates in article.§Disappearance of infection-related acute signs and symptoms and return to stability.||Cure or improvement (incomplete symptom resolution without need for another medication or intervention).