Boehringer Ingelheim announced new data analyses from the pivotal Phase III TONADO® 1&2 studies (NCT01431274/NCT01431287)

• In patients with no prior maintenance treatment, tiotropium/olodaterol Respimat® more than doubled the improvement in lung function* compared to Spiriva® Respimat® alone1
• Tiotropium/olodaterol Respimat® showed efficacy across all COPD stages with greatest lung function improvements over Spiriva® Respimat® in early stages of COPD †2,3

Ingelheim, Germany, 21-5-2015 — /EuropaWire/ — Boehringer Ingelheim today announced new data analyses from the pivotal Phase III TONADO® 1&2 studies4 (NCT01431274/NCT01431287). Data showed tiotropium/olodaterol Respimat®‡ provided lung function benefit to patients with chronic obstructive pulmonary disease (COPD) right from the start of maintenance therapy, with the greatest benefit shown in the early stages of the disease. These data were presented today at the American Thoracic Society Congress 2015 in Denver.

The analyses showed:
– Tiotropium/olodaterol Respimat® more than doubled the improvement in lung
function* compared to Spiriva® (tiotropium) Respimat® in patients who had no prior maintenance
bronchodilator therapy at baseline (148ml vs 72ml*)1 (abstract 64799)
– Tiotropium/olodaterol Respimat® provided a significant improvement in lung function* compared to Spiriva®
Respimat® in patients across all COPD stages with greatest improvements seen in patients in the early
stages of COPD†2,3 (abstracts 64575 and 64845)
– Tiotropium/olodaterol Respimat® had a comparable safety profile to Spiriva® Respimat® or Striverdi®
(olodaterol) Respimat® alone5 (abstract 64778)

“These new data analyses for tiotropium/olodaterol Respimat® are encouraging. When the majority of patients first see their doctor, their lung function has already greatly decreased,” said Roland Buhl, Professor of Medicine and Head of the Pulmonary Department at Mainz University Hospital, Germany. “In COPD, decreasing lung function causes shortness of breath which can lead to a downward spiral of reduced physical activity, worsening of symptoms and even further inactivity. The new analyses suggest that tiotropium/olodaterol Respimat® may help improve lung function from the time of diagnosis of COPD when patients are first beginning maintenance therapy.”

Tiotropium/olodaterol is administered via Respimat®, the propellant-free, platform inhaler for Boehringer Ingelheim’s respiratory therapies, including approved and investigational therapies. It is the only inhaler available that actively delivers a unique mist, meaning the patient just needs to breathe in naturally for the medication to go deep into the lungs.6-12

“For nearly a century, Boehringer Ingelheim has been an industry leader in the discovery and development of therapies for respiratory diseases, including COPD,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “Tiotropium/olodaterol Respimat® builds on years of experience with tiotropium – the active ingredient in Spiriva§.We will continue to work with regulatory authorities and hope to make this treatment available for patients and their healthcare providers soon.”

New analyses show tiotropium/olodaterol Respimat® effective irrespective of inhaled corticosteroid (ICS) use13

A further new analysis from the TONADO® studies showed that almost 40% of patients with less severe COPD (GOLD A/B**) were taking ICS at the start of the trials (abstract 64710).14 These data are consistent with previous reports of the over- use of ICS-based therapies early in the management of COPD.15,16 GOLD guidelines recommend the use of ICS only in patients with more severe lung function impairment and at high risk of exacerbations (GOLD C/D).17

Irrespective of whether patients were taking ICS at the start of the trials††, data showed (abstract 64646) that tiotropium/olodaterol Respimat® significantly improved lung function‡‡ over Spiriva® Respimat®(133ml improvement in patients with ICS usage (p<0.001 vs. Tio 5μg) vs. 149ml in patients with no ICS usage (p<0.001 vs. Tio 5μg)).13

Notes to editors

Intended audiences
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

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 146 affiliates and a total of more than 47,700 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.

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 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.

For more information please visit http://www.boehringer-ingelheim.com

____________________________________________
* Improvement in trough FEV1 after 24 weeks of treatment
†Greater improvements seen in patients with GOLD 2 vs 3/4 (based on lung function measurements) and GOLD A/B group compared to the GOLD C/D group (based on self-reported COPD exacerbation history and lung function measurements)
‡In TONADO® 1&2 two doses of tiotropium/olodaterol Respimat® were investigated: 2.5/5µg and 5/5µg. The data included in this press release refer to the tiotropium/olodaterol 5/5µg dose, which is the dose submitted to the regulatory authorities for marketing authorisation
§Delivered by the HandiHaler® and Respimat®
**classified based on reported COPD exacerbation history and lung-function measurements
†† Patient reported ICS use at baseline
‡‡Improvement in trough FEV1 after 24 weeks of treatment

References
__________________________
1 Buhl R, Abrahams R, Grönke L, et al. Tiotropium Plus Olodaterol Fixed-Dose Combination Therapy Provides Lung Function Benefits when Compared with Tiotropium Alone, Irrespective of Prior Treatment with a Long-Acting Bronchodilator: Post Hoc Analyses Of Two 1-Year Studies. ATS 2015 congress Abstract 64799
2 Korn S, Buhl R, Grönke L, et al. Analysis of the Efficacy and Safety of the Fixed-Dose Combination of Tiotropium + Olodaterol in Patients with COPD by Initial Disease Severity. ATS 2015 congress Abstract 64575
3 Buhl R, Abrahams R, Grönke L, et al. Tiotropium + Olodaterol Fixed-Dose Combination Therapy Provides Lung-Function Benefits Compared with Tiotropium Alone in Patients with GOLD A/B and C/D Chronic Obstructive Pulmonary Disease: Post Hoc Analyses of Two 1-Year Studies. ATS 2015 congress Abstract 64845
4 Buhl R, Maltais F, Abrahams R, et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD2-4). Eur Respir J 2015 Apr;45(4):969-79.
5 Buhl R, Tetzlaff K, Korducki L, et al. Pooled safety analysis of adjudicated serious adverse events with the fixed-dose combination of tiotropium + olodaterol. ATS 2015 congress Abstract 64778
6 Newman SP, Brown J, Steed KP, Reader SJ, Kladders H. Lung deposition of fenoterol and flunisolide delivered using a novel device for inhaled medicines: Comparison of Respimat® with conventional metered-dose inhalers with and without spacer devices. Chest 1998; 113: 957-963.
7 Pitcairn G, Reader S, Pavia D, Newman S. Deposition of corticosteroid aerosol in the human lung by Respimat® Soft Mist™ Inhaler compared to deposition by metered dose inhaler or by Turbuhaler® dry powder inhaler. J Aerosol Med 2005; 18(3): 264-272.
8 Peterson JB, Prisk GK, Darquenne C. Aerosol deposition in the human lung periphery is increased by reduced-density gas breathing. J Aerosol Med Pulm Drug Deliv. 2008 Jun; 21(2): 159–168.
9 Dalby R, Spallek M, Voshaar T. A review of the development of Respimat® Soft Mist™ Inhaler. Int J Pharm 2004; 283: 1-9.
10 Zierenberg B. Optimising the in vitro performance of the Respimat®. J Aerosol Med 1999; 12 (Suppl 1): S19-S24.
11 Dalby RN, Eicher J, Zierenberg B. Development of Respimat® SoftMist™ inhaler and its clinical utility in respiratory disorders. Med Devices (Auckl) 2011; 4: 145-155
12 Anderson P. Use of Respimat Soft Mist Inhaler in COPD patients. Int J Chron Obstruct Pulmon Dis.&nbsp; 2006:1(3) 251–259
13 Korn S, Buhl R, Grönke L, et al. Analysis of the Efficacy and Safety of the Fixed-Dose Combination of Tiotropium + Olodaterol in Patients with COPD by Previous Usage of Inhaled Corticosteroids. ATS 2015 congress Abstract 64646
14 Watz H, Ferguson GT, Grönke L, et al. Inhaled Corticosteroid Plus Long-Acting β2-Agonist Therapy is Overused in the Treatment of Patients with Chronic Obstructive Pulmonary Disease: Post Hoc Analyses of Two 1-Year Studies. ATS 2015 congress Abstract 64710.
15 Yawn B, Kleerup E, Zhang J, et al. Inhaled Corticosteroid Use And GOLD Severity Stage Among Patients With Chronic Obstructive Pulmonary Disease In Different Regions. Am J Resp Crit Care Med 2012; 185: A2944.
16 Small M, Broomfield S, Higgins V. Quantification and Treatment Patterns of Real-World Patients Classified by the GOLD 2011 Strategy. Thorax 2012; 67: A144-A145 doi:10.1136/thoraxjnl-2012-202678.246 (Abstract P185).
17 From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015. Available from: http://www.goldcopd.org/. (Accessed March 2015).

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