Effects of beclomethasone/formoterol fixed combination on lung hyperinflation and dyspnoea in COPD patients. A pilot study.

Background: Chronic obstructive pulmonary disease (COPD) is a common disease characterized by airflow obstruction and lung hyperinflation leading to dyspnoea and exercise capacity limitation.Objectives: the present study was designed to evaluate whether an extra-fine combination of beclomethasone and formoterol (BDP/F) was effective in reducing air trapping in COPD patients with hyperinflation. Fluticasone salmeterol (FP/S) combination treatment was the active control.Methods: COPD patients with FEV1 <65% and plethysmographic functional residual capacity 120% of predicted were randomized to a double-blind, double-dummy, 12 week, parallel group, treatment with either BDP/F 400/24 µg/day or FP/S 500/100µg/day. Lung volumes were measured with full body plethysmography and dyspnoea was measured with transition dyspnoea index.Results: 18 patients were evaluable for intention to treat. A significant reduction in air trapping and clinically meaningful improvement in transition dyspnoea index total score was detected in the BDP/F group but not in the FP/S group. Functional residual capacity, residual volume (RV) and total lung capacity significantly improved from baseline in the BDP/F group only. With regard to group comparison, a significantly greater reduction in RV was observed with BDP/F vs. FP/S. Conclusion: BDP/F extra-fine combination is effective in reducing air trapping and dyspnoea in COPD patients with lung hyperinflation.