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Background: The use of inhaled corticosteroids (ICS) and long-acting β 2  adrenergics (LABA) in fixed combination (ICS/LABA) was recently extended to COPD patients with a baseline FEV 1  50—60% predicted, thus broadening the original guideline indications (GOLD 2006) that limited their use only to stages III and IV.    Method: The present study was carried out to assess the clinical profile of this new subset of patients, with a view to providing data for future studies on the impact of this novel extension of ICS/LABA use in COPD.    Results: Data from the present observational cross-sectional study suggest that COPD patients with FEV 1  50—60% predicted depict a dichotomic condition: actually, even though resembling milder patients in terms of frequency and severity of their respiratory symptoms, they are much more similar to severer patients in terms of rate of hospital admissions and resource consumption (p50.01). In other words, this subset of patients seems to represent a peculiar condition in the evolutional phase of COPD during which therapeutic treatment should be intensified in order to slow down the disease progression effectively. Nevertheless, independently of the severity, the general therapeutic approach to COPD was found to be greatly inadequate when compared to GOLD guidelines, particularly in terms of appropriateness.    Conclusions: These findings should pave the way for future studies aimed to long-term monitoring of main outcomes and to evaluate the overall impact of earlier ICS/LABA use on disease progression and lung function decline in COPD.

Clinical and pharmacoeconomic profile of COPD patients with FEV1 50—60% predicted: pilot study on the impact of the extended indication of ICS/LABA