The European respiratory journal : official journal of the European Society for Clinical Respiratory Physiology
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Randomized Controlled Trial
Physiological effects of roflumilast at rest and during exercise in COPD.
The purpose of this study was to investigate the effects of 500 μg roflumilast, taken once daily for 12 weeks, on airway physiology during rest and exercise in patients with moderate-to-severe chronic obstructive pulmonary disease. This randomised, double-blind, placebo-controlled, parallel-group study was conducted in 250 patients with a post-bronchodilator forced expiratory volume in 1 s (FEV(1)) of 30-80% predicted and a functional residual capacity of ≥ 120% pred. Pre- and post-bronchodilator spirometry and body plethysmography, and pre-bronchodilator constant work rate cycle exercise at 75% of peak work rate were evaluated. ⋯ At a standardised exercise time after roflumilast, compared with placebo, IC increased by 0.12 L (p = 0.008) and S(p,O(2)) increased by 0.7% (p = 0.020); peak ventilation increased by 1.9 L · min(-1) (p = 0.014). Roflumilast treatment was associated with progressive improvement of airway function but not lung hyperinflation. Newly described non-bronchodilator effects of roflumilast included small but consistent improvements in air trapping and S(p,O(2)) during exercise.