TONADO™ study finds significant improvement in lung function and quality of life with tiotropium + olodaterol Respimat®* ‡ Soft Mist Inhaler FDC in chronic obstructive pulmonary disease

  • First presentation of pivotal Phase III TONADO™ results for the only fixed-dose combination (FDC) containing tiotropium1,†
  • Well-tolerated, with a favourable safety profile similar to either treatment alone2
  • Data support recent regulatory submissions for tiotropium + olodaterol Respimat®* ‡

BURLINGTON, ON, Sept. 15, 2014 /CNW/ - Data presented recently at the European Respiratory Society (ERS) International Congress 2014 from the pivotal Phase III TONADO™ studies for tiotropium + olodaterol Respimat®* ‡ found that tiotropium + olodaterol Respimat®* ‡ brought further lung function and quality of life benefits to patients than either compound alone.1 The 52-week studies involved more than 5,000 patients with COPD and have been part of the recent regulatory submissions for tiotropium + olodaterol Respimat®* ‡ as a COPD maintenance therapy. TONADO™ is part of the Phase III TOviTO™ clinical trial program. Involving more than 8,000 patients, TOviTO™ is one of the largest trial programs conducted in COPD.3

COPD is a chronic disease that affects more than 800,000 Canadians.4  It is believed that 1.6 million Canadians may have COPD but remain undiagnosed.5 It is a significant burden on patients and the fourth leading cause of death in Canada, and is expected to be the third leading cause of death worldwide by the year 2020.6,7

Results from TONADO™ showed tiotropium + olodaterol Respimat®* ‡ provided a significant improvement in lung function and health-related quality of life over the mono-components.1

"These results suggest that tiotropium and olodaterol Respimat®* ‡ could potentially help patients return to a more independent life," said Dr. François Maltais, respirologist at the Quebec Heart & Lung Institute, professor, Faculty of Medicine, Laval University. "Tiotropium has been proven to reduce the risk of COPD exacerbations and trips to the hospital. This combination treatment appears to confer even greater optimization of lung function."

"Tiotropium alone has been shown to reduce both trips to the hospital and the risk of COPD exacerbations," said Dr. Denis O'Donnell, professor, Medicine, Rehabilitation Medicine, Biomedical & Molecular Sciences, Kinesiology & Health Studies, Queen's University. "This new data shows that the combination treatment may be more effective than either molecule alone for lung function – an important development for the treatment of this challenging disease."

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*The fixed-dose combination of tiotropium + olodaterol is an investigational compound. Its safety and efficacy has not yet been fully established and it is currently not authorized for sale in Canada.
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 are for the tiotropium 5µg/olodaterol 5µg dose, which is the FDC* dose submitted to the regulatory authorities for marketing authorization.
 ‡Tiotropium + olodaterol is a Fixed-Dose Combination medication delivered via Respimat™ Soft Mist Inhaler Fixed-Dose Combination

ABOUT BOEHRINGER INGELHEIM (CANADA) LTD.

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.

The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs more than 550 people across Canada.

References:

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1 Buhl, R. 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.
2 Buhl, R. 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.
3 TOviTO™ clinical trial programme backgrounder. http://www.newshome.com/education_hub1/respiratory/backgrounders/TOviTO_backgrounder.html. Accessed September 2, 2014.
4 Statistics Canada. Fast Facts about Chronic Obstructive Pulmonary Disease http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/health104a-eng.htm. Accessed at August 12, 2014.
5 The Lung Association. Chronic Obstructive Pulmonary Disease (COPD) in Canada. http://www.lung.ca/pdf/copd/COPD_in_Canada.pdf Accessed September 4, 2014
6 O'Donnell, DE. et al. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease – 2008 update –highlights for primary care. Can Respir J. 2008. 15(Suppl A):1A-8A.
7Camp PG. Levy RD. A snapshot of chronic obstructive pulmonary disease in British Columbia and Canada. BCMJ. 2008. 50(2): 80.

SOURCE: Boehringer Ingelheim (Canada) Ltd.

For further information: For more information please visit www.boehringer-ingelheim.ca

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