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A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids.


ABSTRACT: BACKGROUND:Patients with asthma uncontrolled on inhaled corticosteroids may benefit from umeclidinium (UMEC), a long-acting muscarinic antagonist. METHODS:This Phase IIb, double-blind study included patients with reversible, uncontrolled/partially-controlled asthma for ?6?months, receiving ?100 mcg/day fluticasone propionate (or equivalent) for ?12?weeks. Following a 2-week run-in on open-label fluticasone furoate (FF) 100 mcg, patients were randomised (1:1:1) to receive UMEC 31.25 mcg, UMEC 62.5 mcg or placebo on top of FF 100 mcg once-daily for 24?weeks. As-needed salbutamol was provided. Primary and secondary endpoints were change from baseline in clinic trough forced expiratory volume in 1?s (FEV1) and clinic FEV1 3?h post-dose, respectively, at Week 24. Other endpoints included change from baseline in home daily spirometry (trough FEV1, evening FEV1, morning [pre-dose] and evening peak expiratory flow) over 24?weeks. Safety was assessed throughout the study. RESULTS:The intent-to-treat population comprised 421 patients (UMEC 31.25 mcg: n =139, UMEC 62.5 mcg: n =139, placebo: n =143). UMEC 31.25 mcg and 62.5 mcg demonstrated significantly greater improvements from baseline in clinic trough FEV1 at Week 24 (difference [95% CI]: 0.176?L [0.092, 0.260; p<0.001] and 0.184?L [0.101, 0.268; p<0.001], respectively), clinic FEV1 3?h post-dose at Week 24 (0.190?L [0.100, 0.279; p<0.001] and 0.198?L [0.109, 0.287; p<0.001], respectively) and mean change from baseline in daily home spirometry over 24?weeks versus placebo. No new safety signals were identified. CONCLUSIONS:UMEC is a highly effective bronchodilator that leads to improved lung function when administered as a single bronchodilator on top of FF in subjects with fully reversible, uncontrolled/partially-controlled moderate asthma. These data support a favourable benefit/risk profile for UMEC (31.25 mcg and 62.5 mcg). TRIAL REGISTRATION:GSK study ID: 205832; Clinicaltrials.gov ID: NCT03012061.

PROVIDER: S-EPMC7291639 | BioStudies |

REPOSITORIES: biostudies

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