To evaluate the effect of fluticasone propionate (FP)/salmeterol Diskus (FSC) 250/50 BID and placebo (PLA) on lung hyperinflation and exercise endurance. A preliminary comparison of FSC and salmeterol (SAL) was included, allowing for initial evaluation of the contribution of FP to FSC.
A randomized, double-blind, parallel-group, multicenter study was conducted in 185 COPD patients with hyperinflation at rest (mean FEV1=41%, FRC=156% pred). Pre- and 3 hr post-dose spirometry, body plethysmography and constant-load cycle cardiopulmonary exercise tests (at 75% of maximum work rate) were performed at Day 1 (first dose) and Week 8. Post-dose evaluations were used for comparisons of FSC (n=62) and PLA (n=64), pre-dose for FSC and SAL (n=59).
At a standardized time across exercise tests: inspiratory capacity (IC), tidal volume and ventilation were significantly (p≤0.02) greater with FSC than PLA (Week 8 post-dose); and IC was greater (p=0.031) with FSC than SAL (Week 8 pre-dose). No significant safety concerns were associated with the cardiopulmonary exercise tests.
FSC significantly reduced lung hyperinflation at rest and during exercise and increased exercise endurance time compared to PLA. Preliminary comparisons between FSC and SAL suggest superiority of FSC in patients with COPD.
FSC is effective at improving exercise tolerance, a key goal in the management of stable COPD.
D.E. O’Donnell, Grant monies (from industry related sources) Received research grants from GlaxoSmithKline; Consultant fee, speaker bureau, advisory committee, etc. Received consultant fees from GlaxoSmithKline.Treatment Difference at Week 8FSC-PLA (post-dose)FSC-SAL (pre-dose)FEV1, L0.24±0.04*0.09±0.04†FRC, L-0.35±0.12*-0.14±0.12RV, L-0.35±0.13*-0.10±0.14IC, L0.33±0.06*0.12±0.06†Exercise endurance time, sec132±45*66±44Peak ventilation, L/min4.2±1.0*0.7±1.0