FLAME Study Shows Superiority of Ultibro® Breezhaler® over Seretide in Reducing COPD Exacerbations
Ultibro® Breezhaler® met primary endpoint and demonstrated superiority to Seretide® in reducing COPD exacerbations during 52 weeks of treatment
First large-scale study to confirm Ultibro Breezhaler is an effective steroid-free option that both reduces exacerbations and improves lung function in COPD patients with one or more exacerbations in the past year, compared to Seretide
Full FLAME study results to be shared in 2016
Tokyo, Japan – 17 November 2015: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms the information released today by Novartis on the positive first results from the Phase III FLAME head-to-head trial examining the rate of chronic obstructive pulmonary disease (COPD) exacerbations. Once-daily Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg met its primary endpoint (non-inferiority) and furthermore demonstrated superiority to twice-daily Seretide® (salmeterol/fluticasone) 50/500 mcg in reducing the rate of all COPD exacerbations (mild/moderate/severe) over one year of treatment.
This finding is consistent with the earlier LANTERN trial and is now expanded to patients with at least one exacerbation in the previous year. The safety profiles of the two treatments were consistent with their known profiles, according to the initial FLAME results.
The full FLAME study results, including data from further secondary endpoints, will be reported at an appropriate scientific forum in due course.
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