Press release
Feb 22, 2018

Treatment with Ultibro® Breezhaler® improved cardiac function in COPD patients with lung hyperinflation


  • Ultibro® Breezhaler® provided significant improvements in cardiac and lung function in COPD patients with lung hyperinflation, compared to placebo 
  • CLAIM is the first study to investigate the effect of dual bronchodilation on cardiac function 
  • Data published in the Lancet Respiratory Medicine
Tokyo, Japan – 22 February 2018: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) is pleased to confirm that Novartis today announced the publication of the CLAIM* study in the Lancet Respiratory Medicine, which demonstrated that treatment with once-daily Ultibro® Breezhaler® (indacaterol/glycopyrronium 110/50 mcg) significantly improved lung and cardiac function, when compared to placebo, in chronic obstructive pulmonary disease (COPD) patients with lung hyperinflation1.
 
Many people living with COPD are at increased risk of death and disability due to co-morbid cardiovascular disease2. Lung hyperinflation is common in people with COPD3, and has been linked to impaired cardiac function and worsening of COPD symptoms, especially breathlessness4-6. CLAIM is the first study to investigate the effects of dual bronchodilation on cardiac function and lung hyperinflation1.
 
The CLAIM study met its primary endpoint demonstrating that treatment with Ultibro® Breezhaler® led to decreased lung hyperinflation and improvements in cardiac function** after 14 days of treatment1. This translated into clinically relevant patient benefits of improved health status and breathlessness (dyspnea), studied as exploratory endpoints1.
Commenting on the publication, Peter Bains, CEO at Sosei, said: “The CLAIM study provides yet another example of the strength of the Ultibro® Breezhaler® product and of the benefits it can bring to COPD patients, particularly the significant portion that also suffer from lung hyperinflation.”
 
In the CLAIM study Ultibro® Breezhaler® was well tolerated and its safety profile was comparable with placebo1
 
 
Ultibro® and Breezhaler® are registered trademarks of Novartis AG.
* A randomized, cross-over trial to assess the effect of lung deflation with indacaterol/glycopyrronium on ventricular filling in hyperinflated COPD patients: The CLAIM study
 
References
1. Hohlfeld JM, Vogel-Claussen J, Biller H et al. Effect of lung deflation with indacaterol plus glycopyrronium on ventricular filling in patients with hyperinflation and COPD (CLAIM): a double-blind, randomised, crossover, placebocontrolled, single-centre trial. Lancet Respir Med 2018. Published online February 21, 2018. http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(18)30054-7/fulltext?elsca1=tlxpr
2. Chen W, Thomas J, Sadatsafavi M. Risk of cardiovascular comorbidity in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. Lancet Respir Med 2015;3:631-39
3. Mayo Clinic. Hyperinflated lungs. What does it mean? Available at: https://www.mayoclinic.org/diseasesconditions/emphysema/expert-answers/hyperinflated-lungs/faq-20058169 [Accessed December 2017].
4. Barr RG et al. Percent Emphysema, Airflow Obstruction, and Impaired Left Ventricular Filling. New Engl J Med. 2010;362:217-227
5. Watz H et al. Decreasing Cardiac Chamber Sizes and Associated Heart Dysfunction in COPD. Chest. 2010;138:3238
6. Rossi, A., Aisanov, Z., Avdeev, S., Di Maria, G., Donner, C.F., Izquierdo, J.L., Roche, N., Similowski, T., Watz, H., Worth, H., et al. (2015). Mechanisms, assessment and therapeutic implications of lung hyperinflation in COPD. Respir. Med. 109, 785–802.
7. 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 December 2017].  
 
 

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