Effectiveness of Antibiotic Therapy for Exacerbations of Chronic Obstructive Pulmonary Disease
Effectiveness of Antibiotic Therapy for Exacerbations of Chronic Obstructive Pulmonary Disease
The purpose of this study is to determine the effectiveness of antibiotic therapy for
 patients with acute exacerbations of mild-to-moderate chronic obstructive pulmonary disease.
Antibiotics are usually prescribed for acute exacerbations of chronic obstructive pulmonary
 disease (COPD) even though their benefit in mild-to-moderate COPD is not demonstrated. The
 aim of this study is to assess the effectiveness of antibiotic therapy for exacerbations of
 COPD, what clinical variables are associated with an improved clinical response with
 antibiotic therapy with respect to placebo and to identify which patients might recover from
 an acute exacerbation without antibiotic therapy. Methodology: prospective, randomised,
 double blind, placebo-controlled clinical trial, in which exacerbations (at least one
 criterion present: increase of dyspnoea, increase of sputum production and/or increase of
 purulence) of patients older than 40 yr., smokers or ex-smokers of more than 10 pack-years,
 with COPD and FEV1 greater than 50%, diagnosed by spirometry and a predicted ratio
 FEV1/FVC<0.7%. Exclusion criteria: severe COPD (FEV1<50%), active neoplasm, tracheotomy,
 pneumonia, hospitalization criteria, patients previously being on antibiotics,
 immunodepressed, history of hypersensitivity to beta-lactams or intolerance to clavulanate,
 enrollment in other clinical trials, patients who refuse to take part in this study, and
 patients who have not had a spirometry test for the past two years. Sample size: 677
 patients. Interventions: first visit: the patient will be given details of the clinical trial
 and will be asked to sign informed consent; other data: sputum color, chest X-ray ordered to
 rule out pneumonia, C-reactive protein levels, and peak flow measurement. The patient will be
 randomised to receive amoxicillin plus clavulanate or placebo and will be scheduled to return
 for a 2nd follow-up visit after 3 or 4 days to assess the clinical response and peak flow
 measurements and to rule out any worsening of the condition. Third visit: scheduled after
 9-11 days to assess the clinical response, drug-compliance and peak flow measurement. Fourth
 visit after 15-20 days for clinical assessment and to observe whether any relapses have
 occurred. Date of the following exacerbation will be recorded.
Inclusion Criteria:

 -  Acute exacerbations (at least one criterion present: increase of dyspnoea, increase of
 sputum production and/or increase of purulence) of

 -  patients older than 40 years old,

 -  smokers or ex-smokers of more than 10 pack-years,

 -  with COPD and FEV1 greater than 50%, diagnosed by spirometry and a predicted ratio
 FEV1/FVC<0.7%.

 Exclusion Criteria:

 -  Severe COPD (FEV1<50%)

 -  Pneumonia

 -  Active neoplasm

 -  Tracheotomy

 -  Criteria for hospitalisation

 -  Patients previously being on antibiotics

 -  Immunodepressed patients

 -  History of hypersensitivity to beta-lactams or intolerance to clavulanate

 -  Enrollment in other clinical trials

 -  Patients who refuse to take part in this study

 -  Patients who have not had a spirometry test for the past two years