Press release
Nov 17, 2015

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. 
 
 
References
1. Clinicaltrials.gov. QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study (FLAME). NCT01782326. Available at: https://clinicaltrials.gov/ct2/show/NCT01782326?term=NCT01782326&rank=1 [Accessed 22 October 2015].
2. Ultibro Breezhaler EU Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/002679/WC500151255.pdf [Accessed 22 October 2015].
3. Vogelmeier C et al. Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes versus placebo, indacaterol, glycopyrronium, tiotropium and salmeterol/fluticasone in patients with COPD. [ATS abstract 40759; Session C45; Date: May 21, 2013 Time: 8:15 -10:45].
4. Vogelmeier C et al. Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes. [ERS 2013 abstract 851178; Session 82; Date: September 8, 2013 Time: 12:5014:40].
5. Banerji D et al. Dual bronchodilation with once-daily QVA149 improves dyspnea and health status and reduces symptoms and rescue medication use in patients with COPD: the IGNITE trials. [ERS 2013 abstract 851388; Session 346; Date: September 10, 2013 Time: 8:30-10:30].
6. Global Alliance Against Chronic Respiratory Diseases (GARD). 8th General Meeting. Available at: http://www.who.int/gard/publications/GARDGMreport2013.pdf [Accessed 22 October 2015].
7. World Health Organization: Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet. http://www.who.int/mediacentre/factsheets/fs310/en/ [Accessed 22 October 2015]. 8. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2014. http://www.goldcopd.org/uploads/users/files/GOLD_Report2014_Feb07.pdf [Accessed 22 October 2015].
9. Global Alliance Against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD_Manual/en/ [Accessed 22 October 2015].
10. Fletcher MJ et al. COPD Uncovered: An International survey on the impact of chronic obstructive pulmonary disease (COPD) on a working age population. BMC Public Health 2011;11:612.
11. daCosta M et al. The burden of chronic obstructive pulmonary disease among employed adults. Int J Chron Obstruct Pulmon Dis 2012;7:211-219. Published online 2012 March 19. doi: 10.2147/COPD.S29280 [Accessed 22 October 2015].

 DOWNLOAD PDF