Press release
May 24, 2017

New analyses of FLAME study data reinforce the potential of Ultibro® Breezhaler® for COPD patients historically treated with steroids

  • New analyses from the FLAME study suggest dual bronchodilator Ultibro® Breezhaler® provides similar or better efficacy versus steroid-containing therapies, regardless of blood eosinophil (a type of white blood cell) counts
  •  Data was published in the centenary issue of the American Thoracic Society’s ‘American Journal of Respiratory and Critical Care Medicine’
  • Together with the International Primary Care Respiratory Group, Novartis is launching physician guidance to support a deeper evaluation of inhaled steroid use in COPD patients

Tokyo, Japan –24 May, 2017: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) has confirmed the announcement by Novartis that further analyses of the head-to-head FLAME study suggest that inhaled corticosteroids (ICS) may not be needed in some chronic obstructive pulmonary disease (COPD) patients with high blood eosinophil (a type of white blood cell) counts. The new data showed that Ultibro® Breezhaler® consistently provided superior or similar benefits over Seretide®* in COPD patients regardless of the eosinophil count1. These results contrast with data suggesting better clinical outcomes with ICS therapies for patients with high eosinophil counts2-5. The data was published in the centenary issue of the American Thoracic Society’s ‘Blue Journal’**1 and solidifies the need for individualized risk-benefit assessments when considering ICS treatments.

The potential for high blood eosinophil counts to be considered as a biomarker to direct the use of a LABA***/ICS combination over dual bronchodilation (LABA/LAMA****) in some patients, has been referenced in the 2017 GOLD (Global Initiative for Chronic Obstructive Lung Disease) report6. FLAME was the first trial to prospectively study the influence of blood eosinophils on the efficacy of ICS-containing therapies versus a LABA/LAMA. The new analyses showed that once-daily Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg was superior to twice-daily Seretide (salmeterol/fluticasone [SFC]) 50/500 mcg in reducing exacerbations (flare-ups), independent of a blood eosinophil count above or below 2%1. In addition, at no cut-off was Seretide more effective than Ultibro Breezhaler1.

With funding support from Novartis, the International Primary Care Respiratory Group (IPCRG) is addressing the appropriate use and safe withdrawal of ICS in COPD patients with the launch of a primary care physician guide. The guide was launched at the recent IPCRG conference in Slovenia and aims to ensure the latest evidence based treatment guidance from the 2017 GOLD report is translated into daily clinical practice. The guide is accessible on the IPCRG website here:


* Seretide® Accuhaler® (salmeterol/fluticasone) 50 microgram /500 microgram /dose inhalation powder.

Seretide and Accuhaler are registered trademarks of the GlaxoSmithKline group of companies

** American Journal of Respiratory and Critical Care Medicine

*** Long-acting beta2-adrenergic agonist

**** Long-acting muscarinic antagonist


  1. Roche N, Chapman K, Vogelmeier C, et al. Blood Eosinophils and Response to Maintenance COPD Treatment: Data from the FLAME Trial. Am J Respir Crit Care Med. 2017;195:9:1125-1127.
  2. Pascoe S, et al. Blood eosinophil counts, exacerbations, and response to the addition of inhaled fluticasone furoate to vilanterol in patients with chronic obstructive pulmonary disease: a secondary analysis of data from two parallel randomised controlled trials. Lancet Respir Med. 2015;3:435-442.
  3. Hinds DR, et al. Identification of responders to inhaled corticosteroids in a chronic obstructive pulmonary disease population using cluster analysis. BMJ Open 2016;6:e010099.
  4. Siddiqui SH, et al. Blood Eosinophils: A Biomarker of Response to Extrafine Beclomethasone/Formoterol in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015; 192:523-525.
  5. Pavord ID, et al. Blood eosinophils and inhaled corticosteroid/long-acting β-2 agonist efficacy in COPD. Thorax 2016; 71:118-125.
  6. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2017. Available at: [Accessed 15 May 2017].