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Editorials |

No More Equivalence Trials for Antibiotics in Exacerbations of COPD, Please

Marc Miravitlles; Antoni Torres
Author and Funding Information

Affiliations: Barcelona, Spain
 ,  Barcelona, Spain
 ,  Dr. Miravitlles is Senior Researcher and Dr. Torres is Director, Institut Clínic de Pneumologia i Cirurgia Toràcica.

Correspondence to: Antoni Torres, MD, FCCP, Servei de Pneumologia, Institut Clínic de Pneumologia i Cirurgia Toràcica (IDIBAPS), Hospital Clínic (escalera 12, planta 0), Villarroel 170, 08036 Barcelona, Spain; e-mail: atorres@clinic.ub.es



Chest. 2004;125(3):811-813. doi:10.1378/chest.125.3.811
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Antibiotic treatment of exacerbations of chronic bronchitis or COPD has been a matter of controversy for many years. The main reasons for this are the difficulties in defining exacerbations and in demonstrating their bacterial etiology. Furthermore, the inclusion of patients with simple chronic bronchitis in the antibiotic trials, ie, without airflow obstruction, in whom exacerbations are frequently a self-limited disease, has hampered the demonstration of the potential benefit of antibiotic therapy. During the last few years, some pivotal studies have demonstrated the relationship between exacerbations and increased bacterial counts,12 the acquisition of new bacterial strains,3 and increased associated bacterial-driven bronchial inflammation,4 which supports the bacterial etiology of some or most exacerbations of COPD. Furthermore, the persistence of bacteria after treatment of the exacerbation (residual bacterial colonization) influences the frequency and severity of the following exacerbations.5 Based on these findings, it is reasonable to assume that an antibiotic that induces faster and more complete eradication in vitro, such as moxifloxacin and other fluoroquinolones, will result in better clinical outcomes compared with other, less active antibiotics.6 However, most clinical trials of antibiotics have compared new drugs with standard therapy in patients with exacerbations who, in most cases, would have never required an antibiotic if treated in real-life conditions. These trials have been designed to fulfill the regulatory agency requirements, and they usually include patients who may be as young as 18 years old and a significant proportion of never-smokers.7 The question is, what kind of “chronic bronchitis” or “COPD” do these people have? A study8 has clearly shown that antibiotics are not better than placebo in these cases and, of course, no differences in efficacy are found between different antibiotics in this clinical setting. However, in well-designed studies, the superiority of antibiotics compared to placebo is clearly demonstrated, both in ambulatory,9 and in severe patients.10

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