Date: 2012-08-30
Type of information: Results
phase: 3
Announcement: results
Company: Novartis (Switzerland)
Product: QVA149 (indacaterol 110 mcg/glycopyrronium bromide 50 mcg)
Action
mechanism: QVA149 (indacaterol 110 mcg/glycopyrronium bromide 50 mcg) is an investigational inhaled, once-daily, fixed dose combination of the long acting beta2-agonist (LABA) indacaterol, and the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide (NVA237).
Disease: chronic obstructive pulmonary disease (COPD)
Therapeutic area: Respiratory diseases
Country:
Trial
details: SPARK was a 64-week, multi-center, randomized, double-blind, parallel-group, active controlled study designed to evaluate the effect of QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) QD versus glycopyrronium 50 mcg and QD OL tiotropium 18 mcg on moderate-to-severe COPD exacerbations in 2,224 patients with severe to very severe COPD.
SPARK is the final study of the IGNITE Phase III clinical trial program intended for initial regulatory filings
Latest
news: * On August 30, 2012, Novartis has announced that the fifth QVA149 (indacaterol maleate / glycopyrronium bromide) Phase III study, SPARK, met its primary endpoint of a reduced rate of moderate-to-severe COPD exacerbations compared to glycopyrronium bromide (Seebri® Breezhaler®).
SPARK is the final study intended for initial regulatory filings of QVA149 in Europe and Japan, which are expected in Q4 2012. US filing of QVA149 is expected at the end of 2014.
SPARK met its primary endpoint by demonstrating that patients treated with once-daily (QD) investigational QVA149 for 64 weeks demonstrated a clinically meaningful and statistically significant lower rate of moderate-to-severe COPD exacerbations compared to patients treated with QD glycopyrronium 50 mcg (p=0.038). The study also showed that the rate of moderate-to-severe exacerbations was numerically lower (p=0.096) in patients on QVA149 compared to open-label (OL) tiotropium 18 mcg.
A further analysis of the data demonstrated that QVA149 was statistically significantly more effective in reducing the overall rate of all exacerbations (mild, moderate and severe) compared to glycopyrronium 50 mcg (p=0.001) and OL tiotropium 18 mcg (p=0.002). The adverse event (AE) profile of QVA149 was similar to both glycopyrronium 50 mcg and OL tiotropium 18 mcg.
To date, the first five studies of the IGNITE QVA149 Phase III clinical trials program have all met their primary endpoints of efficacy, safety, exercise endurance, and reduction of exacerbations. The first five studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK) have already completed in 2012 with three additional studies (BLAZE, ARISE, BEACON) expected to complete by the end of the year.
