Combination long-acting bronchodilator therapy may be more effective than long-acting bronchodilator monotherapy in chronic obstructive pulmonary disease ( COPD ).
The aim of a study was to compare the efficacy and safety of once-daily Umeclidinium / Vilanterol ( UMEC/VI; Anoro Ellipta ) 125/25 mcg with placebo and Umeclidinium ( Incruse Ellipta ) or Vilanterol monotherapy in COPD.
This was a double-blind, placebo-controlled, parallel-group study. A total of 1493 patients were randomized ( 3:3:3:2 ) to 24 weeks of treatment with Umeclidinium / Vilanterol 125/25 mcg, Umeclidinium 125 mcg, Vilanterol 25 mcg, or placebo once-daily via dry powder inhaler.
Primary efficacy endpoint was trough forced expiratory volume in one second ( FEV1 ) on day 169 ( 23-24 h post-dose ). Additional lung-function, symptomatic and health-related quality of life endpoints were also assessed. Safety evaluations included: adverse events, vital signs, electrocardiography and clinical laboratory measurements.
All active treatments significantly improved trough FEV1 vs placebo ( 0.124-0.238 L, all p less than 0.001 ). Improvements with Umeclidinium / Vilanterol 125/25 mcg were significantly greater than for Umeclidinium 125 mcg or Vilanterol 25 mcg ( 0.079 L and 0.114 L; both p less than or equal to 0.001 ).
Improvements for Umeclidinium / Vilanterol 125/25 mcg vs placebo were observed for the transition dyspnea index ( 1.0 unit; p less than 0.001 ), rescue Albuterol use at weeks 1-24 ( -1.5 puffs/day ) and St. George's Respiratory Questionnaire ( -3.60 units, p less than 0.001 ).
No safety signals were observed.
In conclusion, once-daily Umeclidinium / Vilanterol 125/25 mcg was well tolerated and provided greater improvements in lung function, health status, and dyspnea scores compared with monotherapy components and placebo over 24 weeks.
This study supports the use of Umeclidinium / Vilanterol 125/25 mcg for the maintenance treatment of COPD. ( Xagena )
Celli B et al, Chest 2014; Epub ahead of print