Improvements in lung function with umeclidinium/vilanterol versus fluticasone propionate/salmeterol in patients with moderate-to-severe COPD and infrequent exacerbations. Issue 7 (July 2015)

• Record Type: Journal Article
• Authors: Donohue, James F.; Worsley, Sally; Zhu, Chang-Qing; Hardaker, Liz; Church, Alison
• Is Part Of: Respiratory medicine. Volume 109:Issue 7(2015)
• Page Start: 870
• Page End: 881
• Publication Date: 2015-07
• Subjects: Chest -- Diseases -- Periodicals; Chest -- Diseases -- Great Britain -- Periodicals; Respiratory organs -- Diseases -- Periodicals; Respiratory Tract Diseases -- Periodicals; Appareil respiratoire -- Maladies -- Périodiques; Thorax -- Maladies -- Périodiques; Appareil respiratoire -- Maladies -- Traitement -- Périodiques; Electronic journals; 616.2
• DOI: 10.1016/j.rmed.2015.04.018
• Languages: English
• ISSNs: 0954-6111

Abstract

<abstract xml:lang="en" abstract-type="author" id="abs0010"> <title id="sectitle0010">Summary</title> <sec> <title id="sectitle0015">Background</title> <p id="abspara0010">Umeclidinium (UMEC; long-acting muscarinic antagonist [LAMA])/vilanterol (VI; long-acting beta<sub>2</sub>-agonist [LABA]) and fluticasone propionate/salmeterol (FP/SAL) (inhaled corticosteroid/LABA) are approved maintenance therapies for chronic obstructive pulmonary disease (COPD). Two studies compared efficacy and safety of UMEC/VI with FP/SAL in patients with moderate-to-severe COPD with no exacerbations in the previous year.</p> </sec> <sec> <title id="sectitle0020">Methods</title> <p id="abspara0015">In these 12-week, multicenter, double-blind, parallel-group, double-dummy trials, randomized (1:1) patients received once-daily UMEC/VI 62.5/25 mcg or twice-daily FP/SAL 250/50 mcg (DB2114930 n = 353 and 353; DB2114951 n = 349 and 348, respectively; intent-to-treat). Endpoints included 0–24 h weighted mean (wm) forced expiratory volume in 1 s (FEV<sub>1</sub>) (Day 84; primary), trough FEV<sub>1</sub> (Day 85; secondary), other lung function endpoints, dyspnea, quality of life (QoL) and safety.</p> </sec> <sec> <title id="sectitle0025">Results</title> <p id="abspara0020">UMEC/VI demonstrated statistically significant, clinically meaningful improvements in lung function measures versus FP/SAL. For 0–24 h wmFEV<sub>1</sub> (Day 84), improvements with UMEC/VI versus FP/SAL were 74 mL (95% confidence interval [CI]: 38–110; DB2114930) and 101 mL (63–139; DB2114951) (both <italic>p</italic> < 0.001). Trough FEV<sub>1</sub> improvements were 82 mL (45–119) and 98 mL (59–137) (both <italic>p</italic> < 0.001) for UMEC/VI versus FP/SAL, respectively. Both treatments demonstrated similar, clinically meaningful improvements from baseline in dyspnea (Transition Dyspnea Index focal score >1 unit) and QoL (St George's Respiratory Questionnaire Total score >4-unit decrease) in both studies with no statistical differences between treatments. Adverse event rates were similar: 26 and 30% UMEC/VI; 27 and 31% FP/SAL.</p> </sec> <sec> <title id="sectitle0030">Conclusions</title> <p id="abspara0025">Once-daily UMEC/VI 62.5/25 mcg over 12 weeks resulted in statistically significant, clinically meaningful improvements in lung function versus twice-daily FP/SAL 250/50 mcg in patients with moderate-to-severe COPD with infrequent exacerbations. Both treatments improved dyspnea and QoL.</p> </sec> <sec> <title id="sectitle0035">Clinical trial registration</title> <p id="abspara0030"> <ext-link ext-link-type="unknown" id="intref0010" xlink:type="simple" xlink:href="ctgov:DB2114930/NCT01817764" xmlns:xlink="http://www.w3.org/1999/xlink">DB2114930/NCT01817764</ext-link>; <ext-link ext-link-type="unknown" id="intref0015" xlink:type="simple" xlink:href="ctgov:DB2114951/NCT01879410" xmlns:xlink="http://www.w3.org/1999/xlink">DB2114951/NCT01879410</ext-link>.</p> </sec> </abstract>