• First presentation of TONADO™ results for the only fixed-dose combination (FDC) containing tiotropium
• Pivotal Phase III studies for tiotropium + olodaterol Respimat® FDC met lung function and quality of life primary endpoints†,1
• Data support recent regulatory submissions in Europe and US for tiotropium + olodaterol Respimat® FDC
MUNICH, Germany I September 8, 2014 I Data from the pivotal phase III TONADO™ studies†,1 for tiotropium + olodaterol Respimat® FDC were presented for the first time today at the European Respiratory Society (ERS) International Congress 2014. The 52-week studies have involved more than 5,000 patients with COPD and have been part of the recent regulatory submissions in Europe and the US for tiotropium + olodaterol Respimat® FDC as a COPD maintenance therapy. Results showed that tiotropium + olodaterol Respimat® FDC brought even further lung function and quality of life benefits to patients than either compound alone.1 By adding to the significant benefits patients already get from tiotropium, the active ingredient of Spiriva®, the results indicated that an even greater number of patients treated with tiotropium + olodaterol Respimat® FDC may be able to return to a more independent life.1,2
COPD is a chronic disease that affects around 65 million people worldwide.3 It is a large burden for patients and is one of the leading causes of death globally.4 Spiriva® (tiotropium) is the most prescribed COPD maintenance treatment worldwide with unsurpassed real-life experience and a well-established efficacy and safety profile, supported by data from more than 230 trials.5 Olodaterol (Striverdi® Respimat®) is a once-daily, fast-acting‡ and long-lasting bronchodilator (LABA§).6 It has been specifically designed as a preferred combination partner to tiotropium (Spiriva®).
Klaus F. Rabe, Professor of Pulmonary Medicine at the University of Kiel and Director of the Department of Pneumology at Clinic Grosshansdorf, Germany
Klaus F. Rabe, Professor of Pulmonary Medicine at the University of Kiel and Director of the Department of Pneumology at Clinic Grosshansdorf, Germany
“Spiriva® is a mainstay of maintenance therapy in COPD and has proven to consistently reduce the risk of COPD exacerbations and related hospitalisations regardless of COPD severity,” said Klaus F. Rabe, Professor of Pulmonary Medicine at the University of Kiel and Director of the Department of Pneumology at Clinic Grosshansdorf, Germany. “Many COPD patients have benefitted from Spiriva®, and previously I would have thought it would be very difficult to improve on its efficacy.”
Results from TONADO™ showed tiotropium + olodaterol Respimat® FDC provided a significant improvement in lung function and health-related quality of life over the mono-components.1 These data underpin the potential of tiotropium + olodaterol Respimat® FDC as a fast-acting, long-lasting once-daily maintenance treatment option for patients with COPD.1,7
“The results from TONADO™ are very promising for patients with COPD,” Professor Rabe continued. “The level of improvement shown in quality of life scores could, for example, help patients do everyday activities more easily, such as getting washed and dressed, going shopping or walking upstairs.”
Data also showed that tiotropium + olodaterol Respimat® FDC was well tolerated with a favourable safety profile that was similar to tiotropium or olodaterol alone.8
The TONADO™ results, together with the VIVACITO™ data7 presented earlier this year, formed a major part of the recent regulatory submissions in Europe and US for tiotropium + olodaterol Respimat® FDC in COPD.
TONADO™ is part of the Phase III TOviTO™ clinical trial programme. Involving more than 8,000 patients, TOviTO™ is one of the largest trial programmes conducted in COPD.
WISDOM – new questions around ICS based therapy in COPD
Also presented at the ERS International Congress 2014 for the first time, were data from the 52-week WISDOM (Withdrawal of Inhaled Steroids During Optimised bronchodilator Management) trial with simultaneous publication in the New England Journal of Medicine. The WISDOM study has evaluated stepwise ICS withdrawal while receiving Spiriva®** and a LABA in severe to very severe COPD patients with a history of exacerbation. In these patients, GOLD†† guidelines support the addition of ICS to long acting bronchodilator therapy.9
The WISDOM study results imply that in respect of moderate to severe exacerbations, many of these COPD patients may not benefit from the addition of an ICS on top of Spiriva® and a LABA.9
Based on the primary end point,‡‡ WISDOM has shown that, in severe to very severe COPD patients with a history of exacerbation, the risk of moderate/severe exacerbations was comparable between those patients continued on ICS and those where ICS therapy was withdrawn in a stepwise fashion while patients received a baseline maintenance treatment of Spiriva® and a LABA.9
There was a transient numerical increase in severe exacerbations soon after ICS treatment was finally stopped, but this was not sustained over the study period.9
Involving more than 2,400 patients, WISDOM is larger than all the previous ICS-withdrawal studies combined.10-15
Reporting the results of the WISDOM study, Peter Calverley, Professor of Pulmonary and Rehabilitation Medicine, University of Liverpool, UK said, “Showing that many patients with severe and very severe COPD may not require the addition of ICS on top of a combination of tiotropium and a LABA is good news. As a result, these patients may avoid the potential adverse effects associated with ICS therapy, which include an increased risk of developing pneumonia and osteoporosis.”
For more information see the media factsheets:
Tiotropium + olodaterol Respimat® FDC: http://www.newshome.com/events/ers/Tiotropium_olodaterol_backgrounder.html
TONADO™ trials: http://www.newshome.com/events/ers/TONADO_trials_factsheet.html
TOviTO™ clinical trial programme: http://www.newshome.com/events/ers/TOviTO_backgrounder.html
WISDOM study: http://www.newshome.com/events/ers/WISDOM_study_factsheet.htm
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.
For more information please visit www.boehringer-ingelheim.com
References
1Buhl 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. ERS 2014 abstract No. OP1895
2Jones PW. Interpreting thresholds for a clinically significant change in health status in asthma and COPD. Eur Respir J 2002; 19: 398–404
3World Health Organization. Chronic Respiratory Diseases. Burden of COPD. http://www.who.int/respiratory/copd/burden/en/ [last accessed July 2014]
4World Health Organization. Media Centre. Chronic Obstructive Pulmonary Disease (COPD) http://www.who.int/mediacentre/factsheets/fs315/en/ [last accessed July 2014]
5Boehringer Ingelheim data on file
6Ferguson GT, Feldman GJ, Hofbauer P, et al. Efficacy and safety of olodaterol once daily delivered via Respimat® in patients with GOLD 2–4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulmon Dis 2014; 9: 629-645 DOI http://dx.doi.org/10.2147/COPD.S61717
7Derom E, Westerman J, Groenke L, 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 Abstract #A148; Thematic Poster Session: D44
8Buhl R, Abrahams R, Bjermer L, et al. Safety of once-daily tiotropium and olodaterol fixed-dose combination via the Respimat in chronic obstructive pulmonary disease in two 1-year studies. ERS 2014 abstract No. P922
9Magnussen H, Chanez C, Dahl R. et al. The impact of stepwise withdrawal of inhaled corticosteroids on exacerbations in COPD patients receiving dual bronchodilation: WISDOM study. ERS 2014 abstract No. OP1890
10Rossi A, Guerriero M, Corrado A, on behalf of the OPTIMO/AIPO Study Group. Withdrawal of inhaled corticosteroids can be safe in COPD patients at low risk of exacerbation: a real-life study on the appropriateness of treatment in moderate COPD patients (OPTIMO). Respiratory Research 2014; 15:77
11Choudhury AB, Dawson CM, Kilvington HE, et al. Withdrawal of inhaled corticosteroids in people with COPD in primary care: a randomised controlled trial. Respir Res 2007; 8: 93
12Wouters EFM, Postma DS, Fokkens B, et al. Withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: a randomised controlled trial. Thorax 2005; 60: 480-7
13Schermer TRJ, Hendriks AJC, Chavannes NH, et al. Probability and determinants of relapse after discontinuation of inhaled corticosteroids in patients with COPD treated in general practice. Prim Care Respir J 2004; 13: 48-55
14van der Valk P, Monninkhof E, van der Palen J, et al. Effect of discontinuation of inhaled corticosteroids in patients with chronic obstructive pulmonary disease. The COPE study. Am J Respir Crit Care Med 2002; 166: 1358-63
15Jarad NA, Wedzicha JA, Burge PS, Calverley PMA, for the ISOLDE study group. An observational study of inhaled corticosteroid withdrawal in stable chronic obstructive pulmonary disease. Respir Med 1999; 93:161-6
*The fixed-dose combination of tiotropium + olodaterol is an investigational treatment. Its safety and efficacy have not yet been fully established.
†TONADO™ consists of two replicate studies: TONADO™ 1&2. In the studies two doses of tiotropium + olodaterol Respimat® FDC were investigated: 2.5µg/5µg and 5µg/5µg. The data included in this press release refer to the tiotropium 5µg/ olodaterol 5µg dose, which is the FDC dose submitted to the regulatory authorities for marketing authorisation.
‡After the first dose
§Long-acting beta2-agonist
**Tiotropium 18 µg administered via HandiHaler®
††Global initiative for chronic obstructive lung disease
‡‡WISDOM primary endpoint: time to first moderate or severe on-treatment COPD exacerbation during the 12-month randomised period
SOURCE: Boehringer Ingelheim
Post Views: 143
• First presentation of TONADO™ results for the only fixed-dose combination (FDC) containing tiotropium
• Pivotal Phase III studies for tiotropium + olodaterol Respimat® FDC met lung function and quality of life primary endpoints†,1
• Data support recent regulatory submissions in Europe and US for tiotropium + olodaterol Respimat® FDC
MUNICH, Germany I September 8, 2014 I Data from the pivotal phase III TONADO™ studies†,1 for tiotropium + olodaterol Respimat® FDC were presented for the first time today at the European Respiratory Society (ERS) International Congress 2014. The 52-week studies have involved more than 5,000 patients with COPD and have been part of the recent regulatory submissions in Europe and the US for tiotropium + olodaterol Respimat® FDC as a COPD maintenance therapy. Results showed that tiotropium + olodaterol Respimat® FDC brought even further lung function and quality of life benefits to patients than either compound alone.1 By adding to the significant benefits patients already get from tiotropium, the active ingredient of Spiriva®, the results indicated that an even greater number of patients treated with tiotropium + olodaterol Respimat® FDC may be able to return to a more independent life.1,2
COPD is a chronic disease that affects around 65 million people worldwide.3 It is a large burden for patients and is one of the leading causes of death globally.4 Spiriva® (tiotropium) is the most prescribed COPD maintenance treatment worldwide with unsurpassed real-life experience and a well-established efficacy and safety profile, supported by data from more than 230 trials.5 Olodaterol (Striverdi® Respimat®) is a once-daily, fast-acting‡ and long-lasting bronchodilator (LABA§).6 It has been specifically designed as a preferred combination partner to tiotropium (Spiriva®).
Klaus F. Rabe, Professor of Pulmonary Medicine at the University of Kiel and Director of the Department of Pneumology at Clinic Grosshansdorf, Germany
Klaus F. Rabe, Professor of Pulmonary Medicine at the University of Kiel and Director of the Department of Pneumology at Clinic Grosshansdorf, Germany
“Spiriva® is a mainstay of maintenance therapy in COPD and has proven to consistently reduce the risk of COPD exacerbations and related hospitalisations regardless of COPD severity,” said Klaus F. Rabe, Professor of Pulmonary Medicine at the University of Kiel and Director of the Department of Pneumology at Clinic Grosshansdorf, Germany. “Many COPD patients have benefitted from Spiriva®, and previously I would have thought it would be very difficult to improve on its efficacy.”
Results from TONADO™ showed tiotropium + olodaterol Respimat® FDC provided a significant improvement in lung function and health-related quality of life over the mono-components.1 These data underpin the potential of tiotropium + olodaterol Respimat® FDC as a fast-acting, long-lasting once-daily maintenance treatment option for patients with COPD.1,7
“The results from TONADO™ are very promising for patients with COPD,” Professor Rabe continued. “The level of improvement shown in quality of life scores could, for example, help patients do everyday activities more easily, such as getting washed and dressed, going shopping or walking upstairs.”
Data also showed that tiotropium + olodaterol Respimat® FDC was well tolerated with a favourable safety profile that was similar to tiotropium or olodaterol alone.8
The TONADO™ results, together with the VIVACITO™ data7 presented earlier this year, formed a major part of the recent regulatory submissions in Europe and US for tiotropium + olodaterol Respimat® FDC in COPD.
TONADO™ is part of the Phase III TOviTO™ clinical trial programme. Involving more than 8,000 patients, TOviTO™ is one of the largest trial programmes conducted in COPD.
WISDOM – new questions around ICS based therapy in COPD
Also presented at the ERS International Congress 2014 for the first time, were data from the 52-week WISDOM (Withdrawal of Inhaled Steroids During Optimised bronchodilator Management) trial with simultaneous publication in the New England Journal of Medicine. The WISDOM study has evaluated stepwise ICS withdrawal while receiving Spiriva®** and a LABA in severe to very severe COPD patients with a history of exacerbation. In these patients, GOLD†† guidelines support the addition of ICS to long acting bronchodilator therapy.9
The WISDOM study results imply that in respect of moderate to severe exacerbations, many of these COPD patients may not benefit from the addition of an ICS on top of Spiriva® and a LABA.9
Based on the primary end point,‡‡ WISDOM has shown that, in severe to very severe COPD patients with a history of exacerbation, the risk of moderate/severe exacerbations was comparable between those patients continued on ICS and those where ICS therapy was withdrawn in a stepwise fashion while patients received a baseline maintenance treatment of Spiriva® and a LABA.9
There was a transient numerical increase in severe exacerbations soon after ICS treatment was finally stopped, but this was not sustained over the study period.9
Involving more than 2,400 patients, WISDOM is larger than all the previous ICS-withdrawal studies combined.10-15
Reporting the results of the WISDOM study, Peter Calverley, Professor of Pulmonary and Rehabilitation Medicine, University of Liverpool, UK said, “Showing that many patients with severe and very severe COPD may not require the addition of ICS on top of a combination of tiotropium and a LABA is good news. As a result, these patients may avoid the potential adverse effects associated with ICS therapy, which include an increased risk of developing pneumonia and osteoporosis.”
For more information see the media factsheets:
Tiotropium + olodaterol Respimat® FDC: http://www.newshome.com/events/ers/Tiotropium_olodaterol_backgrounder.html
TONADO™ trials: http://www.newshome.com/events/ers/TONADO_trials_factsheet.html
TOviTO™ clinical trial programme: http://www.newshome.com/events/ers/TOviTO_backgrounder.html
WISDOM study: http://www.newshome.com/events/ers/WISDOM_study_factsheet.htm
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.
For more information please visit www.boehringer-ingelheim.com
References
1Buhl 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. ERS 2014 abstract No. OP1895
2Jones PW. Interpreting thresholds for a clinically significant change in health status in asthma and COPD. Eur Respir J 2002; 19: 398–404
3World Health Organization. Chronic Respiratory Diseases. Burden of COPD. http://www.who.int/respiratory/copd/burden/en/ [last accessed July 2014]
4World Health Organization. Media Centre. Chronic Obstructive Pulmonary Disease (COPD) http://www.who.int/mediacentre/factsheets/fs315/en/ [last accessed July 2014]
5Boehringer Ingelheim data on file
6Ferguson GT, Feldman GJ, Hofbauer P, et al. Efficacy and safety of olodaterol once daily delivered via Respimat® in patients with GOLD 2–4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulmon Dis 2014; 9: 629-645 DOI http://dx.doi.org/10.2147/COPD.S61717
7Derom E, Westerman J, Groenke L, 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 Abstract #A148; Thematic Poster Session: D44
8Buhl R, Abrahams R, Bjermer L, et al. Safety of once-daily tiotropium and olodaterol fixed-dose combination via the Respimat in chronic obstructive pulmonary disease in two 1-year studies. ERS 2014 abstract No. P922
9Magnussen H, Chanez C, Dahl R. et al. The impact of stepwise withdrawal of inhaled corticosteroids on exacerbations in COPD patients receiving dual bronchodilation: WISDOM study. ERS 2014 abstract No. OP1890
10Rossi A, Guerriero M, Corrado A, on behalf of the OPTIMO/AIPO Study Group. Withdrawal of inhaled corticosteroids can be safe in COPD patients at low risk of exacerbation: a real-life study on the appropriateness of treatment in moderate COPD patients (OPTIMO). Respiratory Research 2014; 15:77
11Choudhury AB, Dawson CM, Kilvington HE, et al. Withdrawal of inhaled corticosteroids in people with COPD in primary care: a randomised controlled trial. Respir Res 2007; 8: 93
12Wouters EFM, Postma DS, Fokkens B, et al. Withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: a randomised controlled trial. Thorax 2005; 60: 480-7
13Schermer TRJ, Hendriks AJC, Chavannes NH, et al. Probability and determinants of relapse after discontinuation of inhaled corticosteroids in patients with COPD treated in general practice. Prim Care Respir J 2004; 13: 48-55
14van der Valk P, Monninkhof E, van der Palen J, et al. Effect of discontinuation of inhaled corticosteroids in patients with chronic obstructive pulmonary disease. The COPE study. Am J Respir Crit Care Med 2002; 166: 1358-63
15Jarad NA, Wedzicha JA, Burge PS, Calverley PMA, for the ISOLDE study group. An observational study of inhaled corticosteroid withdrawal in stable chronic obstructive pulmonary disease. Respir Med 1999; 93:161-6
*The fixed-dose combination of tiotropium + olodaterol is an investigational treatment. Its safety and efficacy have not yet been fully established.
†TONADO™ consists of two replicate studies: TONADO™ 1&2. In the studies two doses of tiotropium + olodaterol Respimat® FDC were investigated: 2.5µg/5µg and 5µg/5µg. The data included in this press release refer to the tiotropium 5µg/ olodaterol 5µg dose, which is the FDC dose submitted to the regulatory authorities for marketing authorisation.
‡After the first dose
§Long-acting beta2-agonist
**Tiotropium 18 µg administered via HandiHaler®
††Global initiative for chronic obstructive lung disease
‡‡WISDOM primary endpoint: time to first moderate or severe on-treatment COPD exacerbation during the 12-month randomised period
SOURCE: Boehringer Ingelheim
Post Views: 143
