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New study published in The Lancet shows Trimbow® (beclometasone/formoterol/glycopyrronium) superiority over Ultibro® Breezhaler® (indacaterol/glycopyrronium) in reducing COPD exacerbations1

Date: 13/02/2018
  • The TRIBUTE study showed superiority of Chiesi’s extrafine formulation triple combination, Trimbow® (beclometasone/formoterol/glycopyrronium) over Ultibro® Breezhaler® (indacaterol/glycopyrronium) in terms of rate of moderate-to-severe exacerbations in patients affected by Chronic Obstructive Pulmonary Disease (COPD).

Parma, Italy, February 12, 2018 – Chiesi Limited (Chiesi) today announced the Lancet publication of the TRIBUTE study comparing the efficacy of the extrafine formulation triple combination, Trimbow® (beclometasone/formoterol/glycopyrronium)* 87/5/9 mcg to Ultibro® Breezhaler® (indacaterol/glycopyrronium)** 85/43 mcg, in reducing clinically relevant (moderate-to-severe) COPD exacerbations over 52 weeks of treatment.

  • 15% reduction in the rate of moderate-to-severe exacerbations for Trimbow® compared with indacaterol/glycopyrronium; 0.50 vs 0.59 per patient per year, rate ratio 0.848, p=0.0431

Treatment with Chiesi’s triple combination in a extrafine formulation showed a similar safety profile (including pneumonia) to indacaterol/glycopyrronium.

“This study helps to fill some of the evidence gaps in the management of COPD2, by demonstrating the benefit of adding an ICS in patients who still report exacerbations, despite dual bronchodilation. Exacerbations are an important outcome measure which impact on the general well-being and overall status of COPD patients”, said Stefano Petruzzelli, Chief Medical Officer and Head of Global Clinical Development, Chiesi Group. “The 2018 GOLD document3 considers COPD exacerbations as important events in the management of COPD because they negatively impact health status, rates of hospitalization and readmission, and disease progression. It is well established that COPD exacerbations contribute to disease progression and that exacerbations can also cluster in time and once a COPD patient experiences an exacerbation, it will trigger increased susceptibility to another event, further underlining the importance of their prevention. Exacerbations also accelerate the progressive decline in lung function in COPD patients and their frequency is now recognised as a key component of the characterisation of patients with COPD. Therefore, the prevention and treatment of COPD exacerbations (in particular moderate and severe exacerbations) has become a primary focus of health care providers4,5. I believe that the TRIBUTE results may impact the future management and treatment of COPD patients.”

 

TRIBUTE met the primary endpoint, with a significant 15% reduction in the rate of moderate-to-severe exacerbations with Trimbow® compared to indacaterol/glycopyrronium (which is an effective6,7 and widely used treatment in COPD).

 

These data will also be presented at the 2018 Annual Meeting of the American Thoracic Society in San Diego, USA.

 

About TRIBUTE

TRIBUTE was a randomised, parallel-group, double-blind, double-dummy, active controlled Phase 3b study, involving 1532 patients and conducted in 187 sites across 17 countries. This study was the first to compare specifically a fixed triple therapy with a fixed dual bronchodilator combination, both in a single inhaler, in terms of reducing moderate-to-severe exacerbations.


About Trimbow®

Trimbow® 87/5/9 mcg (pressurised metered-dose inhaler) is a twice-daily ICS/LABA/LAMA triple fixed-dose combination approved in the European Union (EU) as a “maintenance treatment in adult patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist (for effects on symptoms control and prevention of exacerbations see section 5.1 [of the Summary of Product Characteristics])”

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004257/WC500233163.pdf

 

About Chiesi Group

Headquartered in Parma, Italy Chiesi Group is an international research-focussed Healthcare group, with over 80 years of experience in the pharmaceutical industry. Chiesi researches, develops and markets innovative drugs in the respiratory therapeutics, specialist medicine and rare diseases areas. Its R&D centres in Italy, France, USA, UK, Denmark and Sweden integrate their efforts to advance Chiesi's pre-clinical, clinical and registration programs. Chiesi employs over 5,000 people, 560 of whom are solely dedicated to Research and Development activities.

 

References

 

  1. Papi A, et al. Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): a double-blind, parallel group, randomised controlled trialLancet. 2018. Available at: https://doi.org/10.1016/S0140-6736(18)30206-X. [Last accessed February 2018]
  2. Cazzola M, Rogliani P, Matera MG. Escalation and de-escalation of therapy in COPD: Myths, realities and perspectives. Drugs 2015; 75: 1575–85.
  3. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018 Report. Available at: http://goldcopd.org/wp-content/uploads/2017/11/GOLD-2018-v6.0-FINAL-revised-20-Nov_WMS.pdf. [Last accessed February 2018]
  4. Celli B.R. and Barnes P.J., Exacerbations of chronic obstructive pulmonary disease (Eur Respir J 2007; 29: 1224–1238)
  5. Wilke S. et al., One-year change in health status and subsequent outcomes in COPD (Thorax. 2015;70:420-5)
  6. Wedzicha JA. et al. Indacaterol-glycopyrronium versus salmeterol-fluticasone for COPD (N Engl J Med 2016; 374: 2222–34)
  7. Wedzicha JA. et al. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study (Lancet Respir Med 2013; 1: 199–209)

 

 

* an inhaled corticosteroid [ICS]/ long-acting beta2-adrenergic agonist [LABA]/ long-acting muscarinic antagonist [LAMA]

** a long-acting beta2-adrenergic agonist/ long-acting muscarinic antagonist