Abstract
Inhaled corticosteroids (ICS) have a class effect of increasing pneumonia risk in patients with COPD. However, pneumonia incidence varies widely across clinical trials of ICS use in COPD. This review clarifies methodological differences in defining and recording pneumonia events in these trials and discusses factors that could contribute to the varying pneumonia incidence. Literature searches and screening yielded 40 relevant references for inclusion. Methods used to capture pneumonia events in these studies included investigator-reported pneumonia adverse events, standardised list of signs or symptoms, radiographic confirmation of suspected cases and/or confirmation by an independent clinical end-point committee. In general, more stringent pneumonia diagnosis criteria led to lower reported pneumonia incidence rates. In addition, studies varied in design and population characteristics, including exacerbation history and lung function, factors that probably contribute to the varying pneumonia incidence. As such, cross-trial comparisons are problematic. A minimal set of standardised criteria for diagnosis and reporting of pneumonia should be used in COPD studies, as well as reporting of patients' pneumonia history at baseline, to allow comparison of pneumonia rates between trials. Currently, within-trial comparison of ICS-containing versus non-ICS-containing treatments is the appropriate method to assess the influence of ICS on pneumonia incidence.
Highlights
Community-acquired pneumonia is one of the most common serious infectious diseases, accounting for almost 1% of all medical admissions [1, 2]
Towards a standardised definition of pneumonia for COPD clinical trials This review has shown that pneumonia in COPD trials has been captured using a variety of methods, including investigator reporting of pneumonia adverse events or confirmation with radiographic imaging with or without the requirement for specific clinical symptoms or laboratory findings, antibiotic and/or antiviral and/or antifungal treatment, or adjudication by an independent committee
Differences in the prevalence of risk factors for pneumonia between study populations may contribute to this variation, and to the ability to detect differences in pneumonia rates and their magnitude
Summary
Community-acquired pneumonia is one of the most common serious infectious diseases, accounting for almost 1% of all medical admissions [1, 2]. The Global Initiative for Chronic Obstructive Lung Disease strategy report recommends addition of inhaled corticosteroid (ICS) treatment for patients with COPD with persistent exacerbations despite receiving mono or dual long-acting bronchodilator therapy [9]. Methods for pneumonia capture and assessment can differ between countries; for example, computed tomography is reported to be most frequently used in Japan and the United States [23] Factors such as the study design, ascertainment of pneumonia events, patient population and characteristics vary between studies. Other factors that may contribute to differing rates of pneumonia reporting in COPD clinical trials of ICS therapy were considered, such as study design and patient population characteristics
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