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

Authors Tzani, Crisafulli, Nicolini G, Aiello M, Chetta A, Clini, Olivieri

Published 4 October 2011 Volume 2011:6 Pages 503—509


Review by Single anonymous peer review

Peer reviewer comments 3

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

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