Boehringer Ingelheim Release: New Data Show Benefit Of Tiotropium/Olodaterol Respimat From The Start Of COPD Maintenance Therapy1,2,3

• 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--(BUSINESS WIRE)--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.

“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.”

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

For ‘Notes to Editors’ and ‘References’ please visit: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/20_may_2015_copd.html

^* 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

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