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Effect of Fluticasone Propionate/Salmeterol on Lung Hyperinflation and Exercise Endurance in COPD^*

^* From Queen’s University (Dr. O’Donnell and Ms. Webb), Kingston, ON, Canada; University of Pittsburgh (Dr. Sciurba), Pittsburgh, PA; Caritas St. Elizabeth’s Medical Center (Dr. Celli), Tufts University School of Medicine, Boston, MA; Dartmouth Hitchcock Medical Center (Dr. Mahler), Lebanon, NH; and GlaxoSmithKline (Dr. Kalberg and Dr. Knobil), Research Triangle Park, NC.

Correspondence to: Denis E. O’Donnell, MD, 102 Stuart St, Kingston, ON, Canada K7L 2V6; e-mail: odonnell{at}post.queensu.ca

Abstract

Study objective: To examine the effect of fluticasone propionate, 250 µg/salmeterol, 50 µg combination (FSC 250/50) twice daily on lung hyperinflation and associated measures of exercise performance in patients with COPD.

Design: This was a randomized, double-blind, parallel-group study.

Patients: Eligible patients were 40 years old with a diagnosis of COPD, prealbuterol FEV₁ < 70% of predicted, FEV₁/FVC ratio 0.70, and functional residual capacity (FRC) 120% of predicted normal.

Interventions: Patients were randomized to FSC 250/50; salmeterol, 50 µg; or placebo twice daily for 8 weeks. Predose and postdose spirometry, plethysmography, and constant-load cycle cardiopulmonary exercise test evaluations were compared. The primary comparison was FSC 250/50 with placebo. The salmeterol group was included for exploratory comparisons with FSC 250/50.

Results: A total of 185 patients (mean baseline FEV₁ of 41% predicted) were enrolled. At rest, FSC 250/50 significantly reduced postdose FRC and increased inspiratory capacity (IC) compared with placebo (differences of – 0.35 ± 0.12 L and 0.33 ± 0.06 L [mean ± SE], respectively, at week 8; p 0.003) and increased exercise endurance time (difference, 132 ± 45 s; p = 0.004). At a standardized time during exercise (isotime), FSC 250/50 increased postdose IC by 0.20 ± 0.05 L over placebo with associated improvements in tidal volume and minute ventilation (p < 0.05 vs placebo at week 8). Improvement in exercise time was significantly correlated with the increase in IC (r = 0.45, p < 0.001) but not FEV₁ (r = 0.23, p = 0.08). Predose comparisons of FSC 250/50 with salmeterol and placebo favored FSC 250/50.

Conclusion: We conclude that FSC 250/50 decreases lung hyperinflation at rest and during exercise with an associated increase in exercise endurance time when compared with placebo.

Key Words: COPD • exercise • fluticasone propionate • inhaled corticosteroid • long-acting ß₂-agonist • lung hyperinflation • salmeterol

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