New large-scale study to investigate effect of tiotropium + olodaterol Respimat® on exacerbations in COPD | boehringer-ingelheim.pt

New large-scale study to investigate effect of tiotropium + olodaterol Respimat® on exacerbations in COPD

For media outside the US, the UK and Canada

  • First patient recruited into DYNAGITO®, which compares effect of tiotropium + olodaterol Respimat®FDC®; to Spiriva® (tiotropium)1, the most prescribed COPD maintenance therapy worldwide2
  • Preventing exacerbations – a sudden, serious worsening of symptoms – is one of the major goals of maintenance treatment in COPD
  • The benefit of tiotropium + olodaterol Respimat® FDC on survival will also be evaluated in this new study1

Ingelheim, Germany, 27th January 2015 – Boehringer Ingelheim today announced that the first patient has been enrolled into its large-scale DYNAGITO® study.1 It will assess the potential benefit of tiotropium + olodaterol Respimat® FDC† compared to Spiriva® (tiotropium) Respimat®‡ on reducing the risk of sudden worsening of symptoms (exacerbations) and improving survival in patients with COPD. The 52-week study aims to involve 7,800 patients in 59 countries. Results are expected in 2017.

Chronic obstructive pulmonary disease, known as COPD, is a serious but treatable lung disease affecting 65 million patients worldwide.3 COPD patients suffer from breathlessness which affects their ability to live their lives to the full from very early on in the disease.4 Sudden worsening of symptoms can occur unexpectedly in patients and can be serious and life-threatening.5

Lead study investigator Peter Calverley, Professor of Pulmonary and Rehabilitation Medicine, University of Liverpool, UK commented, “Exacerbations not only worsen the lung function of COPD patients and often lead to hospitalisation, they also have a significant impact on patients’ overall wellbeing. In severe cases, exacerbations even increase the risk of death. Therefore, there is an ongoing need to optimise the effect of treatment in reducing the risk of exacerbations in COPD.”

Spiriva® is the most prescribed COPD maintenance therapy worldwide.6 The leading position of Spiriva® is supported by proven clinical efficacy in reducing the risk of COPD exacerbations and improving lung function, improving quality of life in COPD patients and positive long term experience across all COPD severities.7-13 Tiotropium + olodaterol Respimat® FDC is a potential new treatment option which builds on the long term experience of Spiriva®, showing, compared to tiotropium alone, greater improvement in lung function, symptom control and health status in patients with COPD.14 It was submitted for marketing authorisation in Europe and the US in 2014.

“The value of tiotropium in reducing the risk of exacerbations is well known. Data from the TONADO® studies suggest that tiotropium + olodaterol Respimat® may reduce the risk of exacerbations even further than tiotropium alone. We look forward to further evaluating the effect of this potential new treatment on exacerbations in a dedicated exacerbation study.” Professor Peter Calverley added.

DYNAGITO® is part of the extensive TOviTO® clinical trial programme for tiotropium + olodaterol Respimat® FDC. TOviTO®, which also encompasses the already reported TONADO®,14 VIVACITO®,15 and TORRACTO®16 studies, includes 12 clinical trials in total. Once DYNAGITO® is completed, TOviTO® will involve over 15,000 patients in more than 50 countries.

Notes to editors

About DYNAGITO®
DYNAGITO® is a 52-week multi-national double-blind trial designed to investigate the impact of once daily, orally inhaled tiotropium + olodaterol Respimat® FDC (5/5 μg) compared to Spiriva Respimat® monotherapy (5 μg) on exacerbations in patients with severe to very severe COPD.

The primary endpoint of the trial is annualised rate of moderate to severe COPD exacerbation. Additional endpoints include time to first moderate to severe COPD exacerbation, annualised rate of exacerbation leading to hospitalisation, time to first COPD exacerbations leading to hospitalisation and time to all-cause mortality.

The study aims to involve 7,800 patients in 59 countries.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 142 affiliates and a total of more than 47,400 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.

Download our TOviTO® clinical trial programe infographic

Footnotes

* Tiotropium + olodaterol Respimat® FDC (fixed-dose combination) is an investigational treatment. Its safety and efficacy have not yet been fully established
† The dose of tiotropium + olodaterol Respimat® FDC in the trial is 5/5 μg
‡ The dose of Spiriva® Respimat® in the trial is 5 μg

Referências

  1. DYNAGITO clinical trial. Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease. Available at http://clinicaltrials.gov/ct2/results?term=dynagito&Search=Search [last accessed January 2015]
  2. IMS Health, IMS MIDAS™, Q1 2014.
  3. World Health Organization. Chronic Respiratory Diseases. Burden of COPD. http://www.who.int/respiratory/copd/burden/en/ [last accessed January 2015]
  4. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. http://www.goldcopd.org/uploads/users/files/GOLD_Report_2014_Jan23.pdf. [last accessed January 2015].
  5. Aaron SD, Donaldson GC, Whitmore GA, et al. Time course and pattern of COPD exacerbation onset. British Medical Journal. 2011. Available http://thorax.bmj.com/content/early/2011/10/18/thoraxjnl-2011-200768 [last accessed January 2015].
  6. Boehringer Ingelheim data on file
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  8. Casaburi R, Mahler DA, Jones PW, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J. 2002; 19: 217-24.
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  10. Celli B, ZuWallack R, Wang S, et al. Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest. 2003; 124: 1743-8.
  11. Tashkin DP, Celli B, Senn S, et al. On behalf of the UPLIFT® (Understanding Potential Long-term Impacts on Function with Tiotropium) study investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008; 359: 1543-54.
  12. Bateman E, Tashkin D, Siafakas N, et al. The one-year trial of tiotropium Respimat plus usual therapy in COPD patients. Respir Med 2010; 104: 1460-72.
  13. Vogelmeier C, Hederer B, Glaab T, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med 2011; 364(12):1093-1103
  14. Buhl R, Derom E, Ferguson G et al. Once-daily tiotropium and olodaterol fixed-dose combination via the Respimat® improves outcomes vs mono-components in COPD in two 1-year studies. European Respiratory Journal 2015 available: http://erj.ersjournals.com/content/early/2015/01/08/09031936.00136014.full.pdf+html [last accessed January 2015]
  15. Eric Derom, Jan Westerman, Lars Groenke et al. The 24-hour lung function profile of once-daily tiotropium and olodaterol fixed-dose combination compared with placebo and monotherapies in chronic obstructive pulmonary disease. ATS 2014 Publication Number: A6727
  16. Maltais F, Gáldiz Iturri JB, Kirsten A, et al. Effects of 12 weeks of once-daily tiotropium and olodaterol fixed-dose combination on exercise endurance in patients with COPD. Thorax 2014; 69: A186-A187 doi:10.1136/thoraxjnl-2014-206260.378