A randomised trial of fluticasone furoate/vilanterol (50/25 μg; 100/25 μg) on lung function in COPD

• Published in: Respiratory medicine Vol. 107; no. 4; pp. 560 - 569
• Main Authors: Kerwin, Edward M, Scott-Wilson, Catherine, Sanford, Lisa, Rennard, Stephen, Agusti, Alvar, Barnes, Neil, Crim, Courtney
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01-04-2013; Elsevier Limited
• Subjects: Adrenergic beta-2 Receptor Agonists - adverse effects; Adrenergic beta-2 Receptor Agonists - therapeutic use; Aged; Androstadienes - administration & dosage; Androstadienes - adverse effects; Androstadienes - therapeutic use; Antibiotics; Benzyl Alcohols - adverse effects; Benzyl Alcohols - therapeutic use; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - adverse effects; Bronchodilator Agents - therapeutic use; Chlorobenzenes - adverse effects; Chlorobenzenes - therapeutic use; Chronic obstructive pulmonary disease; COPD; Dose-range; Dose-Response Relationship, Drug; Double-Blind Method; Drug Combinations; Drug therapy; Female; Forced Expiratory Volume - drug effects; Glucocorticoids - administration & dosage; Glucocorticoids - adverse effects; Glucocorticoids - therapeutic use; Humans; ICS; Infections; LABA; Lung function; Male; Middle Aged; Mortality; Once-daily; Oxygen therapy; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonary Disease, Chronic Obstructive - physiopathology; Pulmonary/Respiratory; Treatment Outcome; ICS; Once-daily; Lung function; Dose-range; LABA; COPD
• ISSN: 0954-6111; 1532-3064
• DOI: 10.1016/j.rmed.2012.12.014

Summary Background Fluticasone furoate (FF)/vilanterol (VI) is a novel once-daily inhaled corticosteroid/long-acting β2 -agonist combination therapy for COPD. We aimed to assess the efficacy and safety of two strengths of FF/VI (100/25 μg; 50/25 μg) vs. individual components (FF 100 μg, VI 25 μg) and placebo over 24 weeks. Methods Multicentre, randomised, placebo-controlled, double-blind, parallel-group study of patients ( N  = 1030) with moderate-to-severe COPD. All medication was administered once daily in the morning. Co-primary efficacy endpoints were: (1) weighted mean (wm) FEV1 (0–4 h post-dose on day 168) to assess acute lung function effects; and (2) trough FEV1 (23–24 h post-dose on day 169) to assess long-lasting effects. Symptom-related outcomes were analysed and adverse events (AEs) assessed. Results Main findings were: (1) the combination of FF/VI at a strength of 100/25 μg significantly ( p  < 0.001) improved wm FEV1 (173 ml) and trough FEV1 (115 ml) vs. placebo. Similar effects were observed with FF/VI 50/25 μg; (2) no significant difference was seen between FF/VI 100/25 μg and VI 25 μg for trough FEV1 (48 ml, p  = 0.082), while an effect was observed between FF/VI 100/25 μg and FF 100 μg for wm FEV1 (120 ml, p  < 0.001); (3) VI 25 μg over 24 weeks improved lung function vs. placebo significantly for wm FEV1 (103 ml, p  < 0.001) and trough FEV1 (67 ml, p  = 0.017); and (4) no safety signal was observed. Conclusions In subjects with moderate-to-severe COPD, FF/VI 100/25 μg provides rapid and significant sustained bronchodilation at 24 weeks. Lung function is improved to a similar extent with FF/VI 50/25 μg and to a somewhat lesser extent with VI 25 μg. All treatments were well tolerated. GSK study number : HZC112206. ClinicalTrials.gov : NCT01053988.