Press release
Nov 27, 2017

New data showed Ultibro® Breezhaler® significantly improved COPD patients’ lung function after direct switch from Seretide®


  • New data showed switching moderate-to-severe, symptomatic COPD patients to Ultibro® Breezhaler® from Seretide® improved lung function and was well tolerated. 
  • The FLASH study is the first randomized controlled trial to investigate the direct switch of patients to the dual bronchodilator Ultibro® Breezhaler from the steroid-containing Seretide®. 
  • Data presented at the Asian Pacific Society of Respirology (APSR) Congress in Sydney, Australia.


Tokyo, Japan – 27 November, 2017: Sosei Group Corporation (“Sosei”; TSE: 4565) has confirmed the announcement by Novartis of positive results from the FLASH* study examining the safety and efficacy of directly switching moderate-to-severe symptomatic and non-frequently exacerbating† chronic obstructive pulmonary disease (COPD) patients to Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg1 from Seretide® (salmeterol/fluticasone) 50/500 mcg. The study met the primary endpoint demonstrating that switching patients to Ultibro® Breezhaler® resulted in significantly improved lung function (trough FEV1)1.

The FLASH study is the first randomized controlled trial to confirm the benefits of directly switching patients to the Ultibro® Breezhaler®1 from this widely-used steroid-containing therapy, therefore avoiding the side effects of the long-term use of inhaled corticosteroids. Critically, patients were switched without a wash-out period‡ to mimic clinical practice1. The superiority of once-daily Ultibro® Breezhaler® over twice-daily salmeterol/fluticasone in improving lung function2-3 and reducing the rate of COPD exacerbations4 has been established in previous studies.

The results of the FLASH study further reinforce the latest GOLD recommendations, which support the use of dual bronchodilation for the majority of symptomatic COPD patients and limit the use of steroid-containing therapies to specific patient types5.

Importantly, the data released today also indicated that the safety and tolerability profiles of the two treatments were similar.

The FLASH study results were presented at the Asian Pacific Society of Respirology (APSR) Congress in Sydney, Australia (23-26 November 2017).

*Assessment of switching salmeterol/Fluticasone to indacateroL/glycopyrronium in A Symptomatic COPD patient cohort
†Patients with a history of up to one exacerbation in the past year
‡ Unlike most clinical trials, Ultibro Breezhaler was started immediately after stopping salmeterol/fluticasone, to mimic clinical practice 

References

  1. Frith C, Ashmawi C, Krishnamurthy S, et al. Assessing direct switch to indacaterol/glycopyrronium from salmeterol/fluticasone in moderate to severe symptomatic COPD patients: The FLASH study. [APSR 2017 abstract]
  2. Vogelmeier C et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol/fluticasone in patients with COPD (ILLUMINATE): a randomised, double-blind, parallel group study. Lancet Respiratory Medicine. 2013;1(1):51-60
  3. Zhong N, Wang C, Zhou X, et al. LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2015;10:1015-1026
  4. Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol/Glycopyrronium Versus Salmeterol/Fluticasone for COPD Exacerbations. New England Journal of Medicine. 2016. Available at: www.nejm.org/doi/full/10.1056/NEJMoa1516385
  5. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management and Prevention of COPD, 2017. Available at: http://goldcopd.org [Accessed 16 October 2017].

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