Effects of beclomethasone/formoterol fixed combination on lung hyperinflation and dyspnea in COPD patients

Abstract

Panagiota Tzani1, Ernesto Crisafulli2, Gabriele Nicolini3, Marina Aiello1, Alfredo Chetta1, Enrico Maria Clini2, Dario Olivieri1 1Department of Clinical Sciences, University of Parma, Parma, Italy; 2Department of Oncology Haematology and Pulmonary Diseases, University of Modena and Ospedale Villa Pineta, Pavullo, Modena, Italy; 3Medical Affairs Department, Chiesi Farmaceutici SpA, Parma, Italy Background: Chronic obstructive pulmonary disease (COPD) is a common disease characterized by airflow obstruction and lung hyperinflation leading to dyspnea 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 forced expiratory volume in one second <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 500/100 µg/day. Lung volumes were measured with full body plethysmography, and dyspnea was measured with transition dyspnea index. Results: Eighteen patients were evaluable for intention to treat. A significant reduction in air trapping and clinically meaningful improvement in transition dyspnea 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 versus FP/S. Conclusion: BDP/F extra-fine combination is effective in reducing air trapping and dyspnea in COPD patients with lung hyperinflation. Keywords: small airways, chronic obstructive pulmonary disease, airflow obstruction