Once-Daily QVA149 Demonstrates Superior Outcomes in COPD Patients Previously Treated With Fixed-Dose Long-Acting β 2 -Agonist/Inhaled Corticosteroid (LABA/ICS): The ILLUMINATE Study

Abstract

SESSION TITLE COPD ISESSION TYPE: Slide PresentationsPRESENTED ON: Sunday, March 23, 2014 at 04:15 PM - 05:15 PMPURPOSE: The ILLUMINATE study evaluated the superiority of once-daily QVA149 110/50μg, a dual bronchodilator combining the LABA indacaterol and LAMA glycopyrronium, compared to twice-daily LABA/ICS, salmeterol/fluticasone 50/500μg (SFC), in terms of efficacy, safety and tolerability in patients with moderate-to-severe COPD. This analysis reports the efficacy and safety of QVA149 versus SFC in the sub-group population using fixed-dose LABA/ICS prior to study enrollment.METHODS: 122 patients who were on LABA/ICS prior to study entry, were randomized to QVA149 (n=54) and SFC (n=68). FEV1 AUC0-12h, pre-dose trough FEV1, exacerbations and safety were assessed after 26 wks.RESULTS: QVA149 significantly improved FEV1 AUC0-12h, pre-dose trough FEV1 and reduced rescue medication use in COPD patients using LABA/ICS prior to study entry. QVA149 significantly improved FEV1 AUC0-12h in the subpopulation previously treated with LABA/ICS at Wks12 and 26 (Least square mean [LSM] Treatment difference [Td]=0.18L and 0.16L respectively; both p<0.001). These differences were consistent with the results of the overall population (at Wks12 and 26 LSM Td=0.12L and 0.14L respectively; both p<0.001) and thus showed that the improvement in breathlessness is independent of earlier LABA/ICS use. QVA149 significantly improved pre-dose trough FEV1 compared to SFC at Wks12 and 26 in the sub-group population (LSM Td=0.14L and 0.15 L, respectively; both p<0.001). These differences although higher were consistent with the results of the overall population (at Wks12 and 26 LSM Td=0.09L and 0.1L, respectively; both p<0.001). Number of exacerbations (QVA149: 23; SFC: 41) and patients with incidence of adverse events (QVA149: 50%; SFC: 55.9%) was numerically lower with QVA149.CONCLUSIONS: In the sub-population pre-treated with LABA/ICS, QVA149 demonstrated significant improvements in lung function compared to SFC and were consistent with the overall study population. The overall incidence of AEs was similar across the treatment groups.CLINICAL IMPLICATIONS: In population pre-treated with LABA/ICS, QVA149 demonstrated significant improvements in lung function compared to SFC. QVA149 was well tolerated over the 26-wk treatment period in this population demonstrating consistency with previous results.DISCLOSURE: Karen Mezzi: Employee: Novartis Employee John Pallante: Employee: Novartis Employee Vijay Alagappan: Employee: Novartis Employee Hungta Chen: Employee: Novartis Employee Donald Banerji: Employee: Novartis EmployeeClinical trial results of QVA149, combination of two approved products indacaterol and glycopyrronium, will be presented, QVA149 is in the late stage phase 3 trials prior to approval.