Boehringer Ingelheim announced data which add to the growing body of evidence that show Spiolto® (tiotropium/olodaterol) Respimat® enables greater physical activity in patients living with COPD. VESUTO® and OTIVATO® data were presented during the American Thoracic Society meeting (ATS) and PHYSACTO® data was recently published in the American Journal of Respiratory and Critical Care Medicine. (1,2,3)
Activity-related breathlessness is a characteristic feature of COPD.(5) It limits patients' exercise tolerance and has an impact on their daily activities, which can lead to a downward spiral of exercise avoidance and physical decline.(5,6) Decreased activity results in patients experiencing further breathlessness during even lower levels of physical activity, leading to further worsening of their condition, and increasing the risk of disability and death.(7) The internationally-recognised GOLD 2018 Strategy recommends maintaining or increasing physical activity for all COPD patients, regardless of disease severity.(4)
"It is of paramount importance that people with COPD remain as active as possible to minimise the impact of the disease on their daily lives," said Professor Thierry Troosters, Head of the Research Group for Cardiovascular and Respiratory Rehabilitation, University of Leuven, Belgium and principal investigator for the PHYSACTO® study. "The VESUTO®, OTIVATO®, and PHYSACTO® studies collectively show how tiotropium/olodaterol, a LAMA/LABA therapy, makes it easier for people with COPD to engage in physical activity by reducing symptoms and difficulty related to physical activity, thus improving their ability to exercise."
"Breathlessness is one of the hardest symptoms I deal with, but I try to do something active every day," said Simon Barson, who has been living with COPD for 10 years. "Even though I get myself extremely exhausted when I cycle or walk, I do it anyway because I know I'll get my breath back. I always feel better when I have exercised than when I have not."
Recently presented and published study data include:
- The VESUTO® study examined the efficacy of tiotropium/olodaterol on lung hyperinflation, exercise capacity and physical activity compared with tiotropium alone, in Japanese patients.(2) In VESUTO®, tiotropium/olodaterol therapy demonstrated a significant improvement in hyperinflation compared with tiotropium, and showed a potential enhancement of exercise capacity in COPD patients.(2)
- The OTIVATO® study examined the effect of tiotropium/olodaterol versus tiotropium alone on breathlessness in patients with COPD during a 3-minute constant speed shuttle test, to assess exertional breathlessness during walking.(1) In OTIVATO®, tiotropium/olodaterol significantly reduced the intensity of breathlessness during walking compared to tiotropium alone.(1)
- The PHYSACTO® study assessed the effects of tiotropium/olodaterol alone or in combination with 8 weeks of exercise training on exercise capacity and levels of physical activity in patients with moderate-to-severe COPD.(3,8) In PHYSACTO®, tiotropium/olodaterol with or without exercise training increased exercise capacity in people with moderate to severe COPD significantly compared to those receiving placebo.(3,8) A 12-week self-management behaviour modification programme was included for all four groups to provide an optimal environment for translating improvements in exercise capacity into increases in daily activity.(3,8)
These new data build on results from the MORACTO® 1&2 and TORRACTO® studies, and together demonstrate that tiotropium/olodaterol significantly reduces lung hyperinflation, reduces breathlessness during exercise and improves exercise endurance time enabling greater physical activity in patients living with COPD.(1,2,3,9,10) The OTIVATO® and PHYSACTO® trials are part of the large-scale TOviTO® Phase III clinical trial programme investigating the efficacy and safety of tiotropium/olodaterol Respimat® in COPD.(11,12,13,14,15,16,17,18,19,20)
About COPD
COPD is a growing world health priority and the World Health Organization predicts it will become the third leading cause of death by 2030.(21) It is a progressive disease that limits airflow in and out of the lungs, making it difficult for patients to breathe and limiting their involvement in daily activities, even from very early on in the disease.(6,22,23) Long-term prognosis for patients following hospitalisation for COPD exacerbation is poor, with 50% of patients dying within five years.(4)
About Spiolto® Respimat® (tiotropium/olodaterol)
Tiotropium/olodaterol is approved as once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. It is built on tiotropium, the active ingredient in Spiriva® and is enhanced by olodaterol (Striverdi®) which was specifically designed to complement the efficacy of tiotropium. Tiotropium/olodaterol provides significant improvements in lung function, COPD symptoms and quality of life over tiotropium - right from the initial stages when suitable patients need maintenance therapy.(10,12,13,24) Tiotropium/olodaterol is administered via Respimat®, the only inhaler available that actively delivers a unique mist, meaning a person just needs to take a slow deep breath to get the medication deep into the lungs.*(25,26,27,28,29)
About Boehringer Ingelheim
Improving the health and quality of life of patients is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention.Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2017, Boehringer Ingelheim achieved net sales of nearly 18.1 billion euros. R&D expenditure, exceeding three billion euros, corresponded to 17.0 per cent of net sales.
As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success, rather than short-term profit. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment.
* Minimal inspiratory effort needed.
1. Maltais F et al. The effect of tiotropium/olodaterol vs tiotropium on breathlessness during the 3-minute constant speed shuttle test in patients with chronic obstructive pulmonary disease. Poster presented at ATS May 20 2018
2. Ichinose M et al. Efficacy of tiotropium/olodaterol on lung hyperinflation, exercise capacity and physical activity in Japanese patients with chronic obstructive pulmonary disease (VESUTO Study): A randomized crossover trial. Poster presented at ATS May 21 2018
3. Troosters T et al. Effect of bronchodilation and exercise training with behavior modification on exercise tolerance and downstream effects on symptoms and physical activity in COPD. Am J Respir Crit Care Med. 2018. Available from: https://doi.org/10.1164/rccm.201706-1288OC
4. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2018 Report. Available at: http://goldcopd.org/wp-content/uploads/2017/11/GOLD-2018-v6.0-FINAL-revised-20-Nov_WMS.pdf [last accessed May 2018]
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8. Troosters T et al. Effect of 8 and 12 weeks’ once-daily tiotropium/olodaterol, alone and combined with exercise training, on exercise endurance during walking in patients with COPD. Eur Respir J 2016; 48: PA976
9. O’Donnell D et al. Effects of 6 weeks' treatment with once-daily tiotropium and olodaterol fixed-dose combination on inspiratory capacity and exercise endurance in patients with COPD: The MORACTO™ studies. American J of Resp and Critical Care Med. 2015;3972
10. Maltais F 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
11. Buhl R et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD2-4). Eur Respir J 2015; 45(4): 969-79
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14. Singh D et al. Effects of tiotropium+olodaterol versus tiotropium or placebo by COPD disease severity and previous treatment history in the OTEMTO® studies. Respir Res. 2016 Jun 18; 17(1): 73
15. Calverley P et al. Lancet Respir Med 2018 Published Online March 28, 2018 http://dx.doi.org/10.1016/S2213-2600(18)30102-4
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17. O’Donnell DE et al. Effects of combined tiotropium/olodaterol on inspiratory capacity and exercise endurance in COPD. Eur Respir J 2017; 49:1601348
18. Beeh KM et al. The lung function profile of once-daily tiotropium and olodaterol via Respimat® is superior to that of twice-daily salmeterol and fluticasone propionate via Accuhaler® (ENERGITO® study). Int J Chron Obstruct Pulmon Dis 2016; 11: 193-205
19. Troosters T et al. Enhancing exercise tolerance and physical activity in COPD with combined pharmacological and non-pharmacological interventions: PHYSACTO randomised, placebo-controlled study design. BMJ Open 2016; 6: e010106
20. Bourbeau J et al. Behaviour-change intervention in a multicentre, randomised, placebo-controlled COPD study: methodological considerations and implementation. BMJ Open 2016; 6: e010109
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23. Calverley P. Review COPD: what is the unmet need? British J of Pharma 2008; 115: 487-493
24. SPIOLTO® RESPIMAT® Summary of Product Characteristics, February 2017
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28. Dalby RN et al. Development of Respimat® SoftMist™ inhaler and its clinical utility in respiratory disorders. Med Devices (Auckl) 2011; 4: 145-155
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