Press release
Dec 9, 2016

Ultibro® Breezhaler® improved lung function and COPD symptoms after direct switch from previous treatment


  • Ultibro® Breezhaler® improved lung function and breathlessness after direct switch from long-acting bronchodilators or steroid-containing combination therapies 
  • Results further support the 2017 GOLD recommendations that dual bronchodilation should be the foundation treatment for the majority of symptomatic COPD patients 
  • Data from the pragmatic CRYSTAL study showcased for the first time at the 2016 British Thoracic Society Winter Meeting in London, UK

Tokyo, Japan – 9 December 2016: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms the announcement by Novartis of positive results from the first large-scale study exploring the effects of directly switching symptomatic, non-frequently exacerbating patients with moderate COPD from their current treatments, including steroid-containing combinations and long-acting bronchodilators, to the dual bronchodilator Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg.

In the CRYSTAL study, patients with moderate COPD who were switched to Ultibro Breezhaler from their previous therapy (LABA+ICS or LABA or LAMA†) experienced superior improvements in lung function (trough FEV1) and breathlessnessǂ at week 12 (p<0.0001). Significantly, CRYSTAL is the first LABA/LAMA pragmatic trial, designed to mimic clinical practice, so treatment switching occurred without a washout period1.

Ultibro Breezhaler was also well tolerated in the CRYSTAL study1.

About CRYSTAL

CRYSTAL was a prospective, multicenter, 12-week, randomized, pragmatic, open-label trial. Patients were recruited into four groups according to previous medication and symptoms, and randomized to a direct switch to Seebri® Breezhaler® (glycopyrronium) 50 mcg or Ultibro® Breezhaler® (indacaterol/glycopyrronium)110/50 mcg once daily vs. continuation of previous treatment. The study enrolled a total of 4,389 symptomatic, non-frequently exacerbating (up to one exacerbation in the previous year) patients with moderate COPD and 2,159 patients received Ultibro Breezhaler or continued their baseline therapy. The Seebri Breezhaler treatment arms of the study were underpowered due to sample size.

Co-primary objectives of the study were:

  • Superiority of Ultibro Breezhaler vs. LABA, LAMA and LABA+ICS in terms of improvement of lung function (trough FEV1) and breathlessness (transition dyspnoea index) at week 12.
  • Superiority of Seebri Breezhaler vs. previous SABA and/or SAMA§ treatment in terms of improvement of lung function (trough FEV1) and breathlessness (transition dyspnoea index) at week 12
  • Non-inferiority of Seebri Breezhaler vs. previous LABA or LAMA treatment in terms of improvement of lung function (trough FEV1) and breathlessness (transition dyspnoea index) at week 12.

Notes

1 Long-acting beta2-adrenergic agonist + inhaled corticosteroid (free or fixed-dose combinations)

† Long-acting muscarinic antagonist

ǂ Transition dyspnea index (TDI)

§ Short-acting beta agonist and/or short-acting muscarinic antagonist

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

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


References

  1.  Vogelmeier C, Aalamian-Mattheis M, Greulich T, et al. Efficacy and safety of the direct switch from various previous treatments to glycopyrronium or indacaterol/glycopyrronium in patients with moderate COPD: The CRYSTAL Study. Abstract presented at the British Thoracic Society Winter Meeting: 6 December 2016
  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 21 November 2016].

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