Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients

• Published in: Respiratory medicine 2014-08, Vol.108 (8), p.1171-1179
• Main Authors: Dransfield, Mark T, Feldman, Gregory, Korenblat, Phillip, LaForce, Craig F, Locantore, Nicholas, Pistolesi, Massimo, Watkins, Michael L, Crim, Courtney, Martinez, Fernando J
• Format: Article
• Language: English
• Subjects: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists - administration & dosage; Adrenergic beta-2 Receptor Agonists - adverse effects; Albuterol - administration & dosage; Albuterol - adverse effects; Albuterol - analogs & derivatives; Androstadienes - administration & dosage; Androstadienes - adverse effects; Benzyl Alcohols - administration & dosage; Benzyl Alcohols - adverse effects; Chlorobenzenes - administration & dosage; Chlorobenzenes - adverse effects; Chronic obstructive pulmonary disease; Confidence intervals; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug therapy; Dry Powder Inhalers; Female; Fluticasone-Salmeterol Drug Combination; Forced Expiratory Volume - drug effects; Glucocorticoids - administration & dosage; Glucocorticoids - adverse effects; Head-to-head; Humans; Inhaled corticosteroid; Long-acting β2-agonist; Lung function; Male; Middle Aged; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonary Disease, Chronic Obstructive - physiopathology; Pulmonary/Respiratory; Studies; Treatment Outcome; Vital Capacity - drug effects
• ISSN: 0954-6111; 1532-3064
• DOI: 10.1016/j.rmed.2014.05.008

Summary Background Fluticasone furoate/vilanterol (FF/VI) is an inhaled corticosteroid/long-acting beta2 -agonist (ICS/LABA), recently approved as once-daily maintenance therapy for COPD. We compared the lung function effects of FF/VI with those of twice-daily fluticasone propionate/salmeterol (FP/SAL). Methods Three 12 week studies comparing FF/VI and FP/SAL were conducted. Patients aged ≥40 years with moderate-to-very severe COPD were randomized to receive double-blind, double-dummy FF/VI 100/25 mcg once-daily, or FP/SAL 250/50 mcg twice-daily for 12 weeks following a 2 week placebo run-in period. The primary endpoint of each study was change from baseline trough in 0–24 h weighted mean FEV1 (wmFEV1 ) on Day 84. Safety was also assessed. Results In Study 1 (HZC113109) (intent-to-treat n : FF/VI = 260; FP/SAL = 259), the increase from baseline in 0–24 h wmFEV1 was significantly greater with FF/VI than FP/SAL (Δ80 mL, P