Chest
Original ResearchCOPDIs It Possible to Identify Exacerbations of Mild to Moderate COPD That Do Not Require Antibiotic Treatment?
Section snippets
Materials and Methods
The methods, design, and outcomes of this trial have been previously described in detail.8 In short, 310 patients with exacerbations of mild to moderate COPD were enrolled from primary care between October 2007 and July 2010 into a multicenter, double-blind, randomized placebo-controlled trial that investigated the efficacy of amoxicillin/clavulanate 500/125 mg tid for 8 days. To investigate the predictors of failure without antibiotics, we analyzed data derived from the 152 patients included
Baseline Characteristics
In the original randomized trial, 310 patients were enrolled. The placebo group of this trial, comprising 152 patients, was used for the current study. Table 1 shows the baseline characteristics of the population treated with placebo according to the type of exacerbation.1 The mean ± SD age of the patients in the placebo group was 67.8 ± 11 years, and 78.3% were men. The mean FEV1 was 65.9 ± 12.1% predicted, and most patients had either a type 2 (47.4%) or a type 1 (29.6%) exacerbation. The
Discussion
The analysis of the placebo arm results of a randomized, double-blind, antibiotic trial in exacerbated mild to moderate COPD provided a unique opportunity to investigate the factors associated with clinical outcomes and to identify patients who can be safely treated without antibiotics in an ambulatory setting.8 We revisited the classic Anthonisen criteria for antibiotic treatment1 and demonstrated that only an increase in sputum purulence was associated with a significant increase in the risk
Acknowledgments
Author contributions: Dr Miravitlles had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Dr Miravitlles: contributed to the study design, participant recruitment and follow-up, and drafting and review of the manuscript.
Dr Moragas: contributed to the study design, trial coordination, and review of the manuscript.
Dr Hernández: contributed to the participant recruitment and follow-up and revision and approval
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Funding/Support: This clinical trial was supported by a grant from the Instituto de Salud Carlos III (Spanish Ministry of Health) (EC07/90333).
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