Background: QVA149 is a dual bronchodilator combining the long-acting β2-agonist(LABA)
indacaterol and the long-acting muscarinic antagonist (LAMA) glycopyrronium, for maintenance
treatment of COPD. This post hoc analysis evaluated the improvements in lung function,
dyspnea, and health status in subgroups of patients based on prior medication use,
disease severities, baseline cough score, and baseline rescue medication use, achieved
with QVA149 compared with placebo and other active comparators in 2 phase III clinical
studies. Methods: In both the SHINE (NCT01202188) and ILLUMINATE (NCT01315249) studies,
symptomatic patients aged ≥40 years with moderate-to-severe COPD were randomized to
once-daily QVA149 (110/50 µg), indacaterol (150 µg), glycopyrronium (50 µg), tiotropium
(18 μg), or placebo (2:2:2:2:1) and once-daily QVA149 (110/50 µg) or twice-daily salmeterol/fluticasone
([SFC]; 50/500 µg), respectively for 26 weeks. Here, we present the improvements in
lung function, transition dyspnea index (TDI) and St. George's Respiratory Questionnaire
(SGRQ) total score by prior medication use and COPD disease severity separately from
both studies. Results: In total, 2144 and 523 patients were randomized in the SHINE
and ILLUMINATE studies; 89.1% and 82.6%, respectively, completed the study. QVA149
showed significant improvements in lung function compared with placebo (SHINE study)
and SFC (ILLUMINATE study) regardless of prior medication, disease severity, baseline
cough score, and rescue medication use. TDI and SGRQ total scores were also improved
with QVA149 compared with placebo and SFC in most of the analyzed subgroups. Conclusion:
QVA149 showed improvements in lung function, dyspnea, and health status in both moderate
and severe COPD patients independent of previous medication use and baseline cough
score.