Efficacy of amoxycillin versus amoxycillin/clavulanate in acute exacerbations of chronic pulmonary obstructive disease in primary care

Carl Llor¹, Silvia Hernández¹, Anna Ribas², Carmen Álvarez³, Josep Maria Cots⁴, Carolina Bayona⁵, Isabel González⁶, Marc Miravitlles⁷, BRAMOX Study Group

¹Primary Care Centre Jaume I, Tarragona, Spain; ²Primary Care Centre Santa Eugènia de Berga, Spain; ³Primary Care Centre Manlleu, Spain; ⁴Primary Care Centre La Marina, Barcelona, Spain; ⁵Primary Care Centre Valls, Spain; ⁶Primary Care Centre Maragall, Barcelona, Spain; ⁷Pneumology Department. Institut Clínic del Tòrax (IDIBAPS), Hospital Clínic, Barcelona, CIBER de Enfermedades Respiratorias (CIBERES), Spain

Background: Amoxycillin/clavulanate is considered first-line treatment for ambulatory exacerbations of COPD. However, narrow-spectrum antibiotics may be as useful for mild to moderate patients.

Objective: To compare the clinical efficacy of amoxycillin versus amoxicyllin/clavulanate in exacerbations of COPD in primary care.

Methods: A randomized, double-blind, noninferiority clinical trial was carried out in eight primary care centers in Catalonia, Spain. Spirometrically-diagnosed patients older than 40 years with COPD, without criteria of hospitalization and Anthonisen’s types I or II exacerbations were included. The main outcome was clinical cure at the end of treatment (EOT) visit on day 10.

Results: A total of 137 patients were enrolled in the study (68 assigned to amoxycillin and 69 to amoxycillin/clavulanate). The mean forced expiratory flow in one second was 61.6% and the mean age was 71.4 years. At EOT, 92.8% of patients in the amoxycillin/clavulanate and 90.9% in the amoxycillin group were considered clinically cured, a statistically non-significant difference. Adverse effects were observed in 11 subjects, 3 in the amoxycillin group and 8 in the amoxycillin/clavulanate group, 2 of whom required a change in treatment.

Conclusions: Amoxycillin was at least as effective clinically and as safe as amoxycilin/clavulanate in the treatment of acute exacerbations of COPD in mild to moderate patients in primary care.

Keywords: exacerbation, chronic obstructive pulmonary disease, randomised controlled trial, amoxycillin, primary care, amoxycillin/clavulanate