Effect of adding roflumilast or ciclesonide to glycopyrronium on lung volumes and exercise tolerance in patients with severe COPD: A pilot study.

COPD is a chronic inflammatory disease characterized by partially reversible airflow limitation. Currently, phosphodiesterase4 inhibitors and inhaled corticosteroids are anti-inflammatory agents that can be used in patients with severe COPD, always added to at least one bronchodilator. In this prospective interventional pilot study, we investigated the effect of adding oral roflumilast 500 μg once-daily or inhaled ciclesonide 160 μg once-daily to glycopyrronium 44 μg once-daily on lung volumes and exercise tolerance in 16 patients with severe COPD, of which 8 received roflumilast and 8 ciclesonide for 8 weeks. Detailed pulmonary function and endurance shuttle tests were performed at time 0, after 2 weeks of glycopyrronium and after 8 weeks of add-on of either roflumilast or ciclesonide. Glycopyrronium increased significantly (p < .05) FEV1 , and IC at rest and at the peak of exercise and improved the walking distance. In particular, it induced a bronchodilation similar to that elicited by salbutamol 800 μg. After 8 weeks of combination therapy, both the trough and the post bronchodilator FEV1 further improved but the increase was very small and not significant. Furthermore, adding either roflumilast or ciclesonide did not provide a further improvement in IC and walking distance. This study provides further evidence of the efficacy of glycopyrronium 44 μg once daily, confirming that improvements in airflow are associated with increases in IC and improvements in exercise tolerance. The addition of anti-inflammatory drugs, regardless of class used, does not seem to add benefits on lung function and exercise tolerance, likely because of the large effect induced by glycopyrronium.