Chest
Original Research: COPDEffect of Fluticasone Propionate/Salmeterol on Lung Hyperinflation and Exercise Endurance in COPD
Section snippets
Subjects
Subjects included clinically stable patients ≥ 40 years old with a diagnosis of COPD21; a cigarette smoking history ≥ 10 pack-years; a prealbuterol FEV1 < 70% of predicted; an FEV1/FVC ratio ≤ 0.70; a functional residual capacity (FRC) ≥ 120% of predicted normal; a baseline dyspnea index (BDI) score < 7; and the ability to complete a work rate of 20 W during an incremental cycle cardiopulmonary exercise test (CPET) at the screening visit. Exclusion criteria included a current diagnosis of
Subject Characteristics
A total of 185 patients were randomized to treatment with FSC 250/50 (n = 62), salmeterol (n = 59), or placebo (n = 64), and 176 patients completed the study. Five of the nine patients who withdrew were in the placebo group, with one patient and three patients in the salmeterol and FSC 250/50 groups, respectively. Demographic, smoking history, dyspnea, lung function, and exercise values at screening are shown in Table 1. Patients had moderate-to-severe COPD, with mean FEV1 values of 39.5 to
DISCUSSION
The results of this study demonstrate that treatment with FSC 250/50 twice daily for 8 weeks resulted in reduced lung hyperinflation at rest, as shown by significant reductions in postdose evaluations of FRC and RV; a reduction in hyperinflation during exercise, as shown by a significant increase in resting and exercise IC, and in Vt and e; and a significant improvement in exercise endurance time when compared with placebo.
The magnitude of decrease in static lung volumes observed with
ACKNOWLEDGEMENT
We wish to acknowledge the contributions of the following investigators: P. Amelung, MD, Baltimore, MD; D. Berry, MD, Bellingham, WA; C. Cooper, MD, Los Angeles, CA; D. Doherty, MD, Lexington, KY; J. Donohue, MD, Chapel Hill, NC; G. Ferguson, MD, Livonia, MI; C. Fogarty, MD, Spartanburg, SC; N. Hanania, Houston, TX; M. Kaye, MD, Minneapolis, MN; B. Make, MD, Denver, CO; E. Robinette Jr, MD, Abingdon, VA; W. Stringer, MD, Torrence, CA; R. ZuWallack, MD, Hartford, CT; J Leech, MD, Ottawa, ON,
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These data have been presented in part at the 2005 Annual meeting of the American College of Chest Physicians in Montreal, QC, Canada; October 29 to November 3, 2005.
Drs. O'Donnell, Sciurba, Celli, and Mahler have served as consultants and Speaker's Bureau members for GlaxoSmithKline and have received research grants from GlaxoSmithKline. Dr. Kalberg and Dr. Knobil are employees of GlaxoSmithKline.
This study was funded by GlaxoSmithKline.
Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).