SESSION TITLE: COPD I
SESSION TYPE: Slide Presentations
PRESENTED ON: Sunday, March 23, 2014 at 04:15 PM - 05:15 PM
PURPOSE: 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 Employee
Clinical 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.