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Int J Chron Obstruct Pulmon Dis · Jan 2011
Randomized Controlled Trial Multicenter StudyEffects of beclomethasone/formoterol fixed combination on lung hyperinflation and dyspnea in COPD patients.
- Panagiota Tzani, Ernesto Crisafulli, Gabriele Nicolini, Marina Aiello, Alfredo Chetta, Enrico Maria Clini, and Dario Olivieri.
- Department of Clinical Sciences, University of Parma, Parma, Italy.
- Int J Chron Obstruct Pulmon Dis. 2011 Jan 1;6:503-9.
BackgroundChronic obstructive pulmonary disease (COPD) is a common disease characterized by airflow obstruction and lung hyperinflation leading to dyspnea and exercise capacity limitation.ObjectivesThe 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.MethodsCOPD 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.ResultsEighteen 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.ConclusionBDP/F extra-fine combination is effective in reducing air trapping and dyspnea in COPD patients with lung hyperinflation.
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