QVA149 ( Ultibro Breezhaler ) is an inhaled fixed-dose combination therapy under development for the treatment of chronic obstructive pulmonary disease ( COPD ). It combines Indacaterol (a long acting beta-2-agonist ) with Glycopyrronium ( a long acting muscarinic antagonist ) as a dual bronchodilator.
The aim of the study was to compare the efficacy, safety, and tolerability of QVA149 versus Salmeterol - Fluticasone ( SFC ) over 26 weeks in patients with moderate-to-severe COPD.
In this multicentre double-blind, double-dummy, parallel-group study, 523 patients ( age 40 years or older, Global Initiative for Chronic Obstructive Lung Disease [ GOLD ] stages II-III, without exacerbations in the previous year ) were randomly assigned ( 1:1; via automated, interactive response technology and stratified for smoking status ) to once-daily QVA149 110/50 mcg or twice-daily Salmeterol - Fluticasone 50/500 mcg for 26 weeks.
Efficacy was assessed in the full analysis set ( randomised patients who received at least one dose of study drug ); safety was assessed in all patients who received at least one dose of study drug.
The primary endpoint was to demonstrate the superiority of QVA149 compared with Salmeterol - Fluticasone for the standardised area under the curve from 0 to 12 h post dose for forced expiratory volume in 1 second ( FEV1 AUC0-12h ) after 26 weeks of treatment.
During the period 2011-2012, 259 patients were randomly assigned to receive QVA149 and 264 to receive Salmeterol - Fluticasone.
At week 26, FEV1 AUC0-12h was significantly higher with QVA149 than with Salmeterol - Fluticasone ( treatment difference 0.138 L; p less than 0.0001 ).
Overall incidence of adverse events ( including COPD exacerbations ) was 55.4% ( 143 of 258 ) for the QVA149 group and 60.2% ( 159 of 264 ) for the Salmeterol - Fluticasone group.
Incidence of serious adverse events was similar between treatment groups ( QVA149, 13 of 258 [ 5.0% ]; Salmeterol - Fluticasone 14 of 264 [ 5.3% ] ); COPD worsening was the most frequent serious adverse event ( one of 13 [ 0.4% ] and three of 14 [ 1.1% ], respectively ).
Once-daily QVA149 provides significant, sustained, and clinically meaningful improvements in lung function versus twice-daily Salmeterol - Fluticasone, with significant symptomatic benefit.
These results indicate the potential of dual bronchodilation as a treatment option for non-exacerbating symptomatic COPD patients. ( Xagena )
Vogelmeier CF et al, The Lancet Respiratory Medicine 2013; 1; 51-60