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First In Class Once-Daily Dual Bronchodilator Ultibro® Breezhaler® (QVA149) Gains Positive CHMP Opinion For The Treatment Of COPD

About the IGNITE clinical trial program

In the Phase III IGNITE clinical trial program, QVA149 is being investigated for the treatment of COPD patients as an inhaled, once-daily, fixed-dose combination of indacaterol maleate and glycopyrronium bromide. IGNITE is one of the largest international clinical trial programs in COPD comprising 11 studies in total (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON, RADIATE, LANTERN, FLAME) with more than 10,000* patients across 52 countries [ 3 ] , [ 6 ] - [ 17 ]. The first eight studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON) completed in 2012. The studies were designed to investigate the efficacy, safety and tolerability, lung function, exercise endurance, exacerbations, shortness of breath and quality of life in patients treated with QVA149.

Results from five of the Phase III IGNITE trials [ 3 ] , [ 6 ] - [ 9 ]supported the CHMP's positive opinion for QVA149 which demonstrated statistically significant improvements in bronchodilation versus treatments widely used as current standards of care [ 1 ]. Data showed that QVA149 significantly improved bronchodilation compared to OL tiotropium 18 mcg, SFC 50 mcg/500 mcg, indacaterol maleate 150 mcg, glycopyrronium 50 mcg and placebo providing a rapid onset within five minutes, and sustained bronchodilation during a 24 hour period which was maintained for up to 26 weeks, along with symptomatic improvements [ 1 ] , [ 3 ] , [ 7 ] , [ 8 ]. These symptomatic improvements included breathlessness, exercise tolerance, rescue medication use and health-related quality of life [ 3 ] - [ 6 ].

*Total refers to all 11 IGNITE studies.

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