To compare the efficacy and safety of the fluticasone/salmeterol combination product 250/50mcg BID via DISKUS (FSC) and ipratropium/albuterol 36/206mcg QID via MDI (IP/ALB) for the treatment of COPD.
A randomized, double-blind, parallel-group study was conducted with patients (n=365) randomized to FSC or IP/ALB for 8 weeks. Patients were ≥40 years of age with symptomatic COPD, a FEV1/FVC ≤0.7 and a FEV1 40 to 70% of predicted normal (baseline mean=43.6%), and no use of inhaled or oral corticosteriods for at least 30 days prior to randomization. Efficacy was evaluated using measures of pulmonary function, dyspnea, patient-evaluated symptoms, and albuterol use. Safety was evaluated using assessments of clincal adverse events and COPD exacerbations.
Mean Change from Baseline at EndpointFSC (n=182)IP/ALB (n=183)p valueAM predose FEV1 (mL)+111−4<0.001FEV1 6-hr AUC (L-hr)*1.390.90<0.001AM PEF (L/min)+37+7<0.001Dyspnea score (TDI)2.71.2<0.001Overall Daytime Sx score (% change)−23.9−14.90.030% Sx-free nights+28.4+7.7<0.001Nighttime awakenings (per night)−0.58−0.20<0.001Sleep Sx score (% change)−29.3−10.80.010% Albuterol rescue-free nights+22.4+8.70.004% Albuterol rescue-free days+37.6+27.70.124*
change from baseline at Week 8Adverse events were reported for 71 (39%) and 77 (42%) of patients in the FSC and IP/ALB groups, respectively. Exacerbations occurred in 11 (6%) FSC and 9 (5%) IP/ALB patients.CONCLUSIONS: FSC treatment resulted in greater improvements in measures of lung function, dyspnea, patient-measured daytime and nighttime symptoms, and albuterol use as compared with IP/ALB. The number of subjects reporting adverse events and COPD exacerbations was similar.
COPD patients treated with FSC DISKUS 250/50 BID demonstrate clinically meaningful benefits in terms of both lung function improvement and symptom management. In addition, patient benefits from FSC are superior to those of IP/ALB.
J.F. Donohue, I am a consultant for GSK., Industry.