New data show Spiolto Respimat provides meaningful quality of life improvement in COPD

• OTEMTO trials show Spiolto Respimat provides clinically meaningful >4 point reduction in SGRQ score compared to placeboⁱ
• The results underline the benefit Spiolto Respimat can bring to the daily life of patients with COPD

For UK medical media only

Boehringer Ingelheim today announced the publication of data from the Phase IIIb OTEMTO 1&2 trials (NCT01964352/NCT02006732), which show Spiolto Respimat (tiotropium/olodaterol) provides consistent, clinically meaningful improvements in quality of life versus placebo.

These data are published today in the journal Respiratory Medicine.¹In COPDⁱⁱ, health-related quality of life is commonly measured using the St George's Respiratory Questionnaire (SGRQ), a disease-specific patient-reported instrument that evaluates symptoms including frequency and duration of cough, wheezing and breathlessness.

A reduction in SGRQ score of 4 points or more is deemed clinically meaningful.ⁱⁱⁱ The OTEMTO trials show Spiolto Respimat provides a reduction in SGRQ total score of 4.67^iv versus placebo.

"The improvement in quality of life provided by Spiolto Respimat in these trials could make a noticeable difference to the daily activity of COPD patients and enable them to maintain a more independent life," said Dave Singh, Professor of clinical pharmacology and respiratory medicine, University of Manchester and lead investigator of the OTEMTO trials. "For example, this could mean that patients no longer take a long time to wash and dress, are able to walk up stairs without stopping or go out to socialise with friends. This level of improvement could make a real difference to the life of a patient with COPD."

Further data from the 1,600 patient OTEMTO trials show Spiolto Respimat provides:

• clinically meaningful improvements in breathlessness compared to placebo (measured by a 1.62 point improvement in TDI focal score^v), reflecting the meaningful quality of life benefits
• consistent improvements in lung function, breathlessness and quality of life compared to Spiriva (tiotropium)
• a safety profile similar to Spiriva or placebo

OTEMTO 1&2 build on the pivotal phase III TONADO trials that demonstrate Spiolto Respimat provides significant improvements in lung function, breathlessness, quality of life and reduction in rescue medication use over Spiriva Respimat right from the initial stages when patients first need maintenance therapy. ^vi The trials are part of the >15,000 patient TOviTO Phase III clinical trial programme, one of the largest trial programmes conducted in COPD.

About Spiolto Respimat

Spiolto Respimat has gained approval in over 15 EU countries, the US, Canada and Australia for use in the treatment of patients with COPD.

Spiolto Respimat is built on tiotropium, the active ingredient in Spiriva the world's most prescribed COPD maintenance treatment with over 40 million patient years of real life experience across all COPD severities.^vii It is enhanced by olodaterol^viii, an effective long-acting beta2-agonist with a fast onset of action, to complement the efficacy of Spiriva. Spiolto is delivered by Respimat, the only inhaler available that actively^ix delivers a unique mist, meaning the patient just needs to breathe in naturally for the medication to go deep into the lungs.^x-xvi

About 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 www.boehringer-ingelheim.co.uk

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References

ⁱ Chronic obstructive pulmonary disease

ⁱⁱ SGRQ total score after 12 weeks of treatment in the combined data set

ⁱⁱⁱ Transition dyspnoea index focal score after 12 weeks of treatment in the combined data set

¹ Singh D, Ferguson GT, Bolitschek J, et al. Tiotropium+olodaterol shows clinically meaningful improvements in quality of life. Res Med 2015 (in press)

² Jones PW. St George's Respiratory Questionnaire: MCID. COPD 2005 Mar;2(1):75-9.

³ 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; 45(4):969-79.

⁴ BI data on file.

⁵ 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.

⁶ 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.

⁷ 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; 21(2):159-168.

⁸ Dalby R, Spallek M, Voshaar T. A review of the development of Respimat Soft Mist™ Inhaler. Int J Pharm 2004;283:1-9.

⁹ Zierenberg B. Optimising the in vitro performance of the Respimat. J Aerosol Med 1999;12 (Suppl 1): S19-S24.

¹⁰ 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.

¹¹ Anderson P. Use of Respimat Soft Mist Inhaler in COPD patients. Int J Chron Obstruct Pulmon Dis. 2006;1(3): 251-259.

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