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Large European real-world study reports effects of Spiolto® Respimat® for people living with COPD in daily clinical practice1

September 17, 2018

INGELHEIM, Germany--(BUSINESS WIRE)--Sep 17, 2018--Boehringer Ingelheim announced results from the OTIVACTO study, an observational European real-world study of 7,443 Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiolto ® (tiotropium/olodaterol) Respimat ®, which were presented today at the European Respiratory Society (ERS) International Congress 2018 in Paris, France. 1 Patients in the study reported both improved physical functioning and general condition and high satisfaction with their inhalation device and treatment overall. 1 The improvements were observed in patients across disease severities. 1

Patients in the OTIVACTO study completed the physical functioning-10 (PF-10) i questionnaire at the beginning and end of the 6-week study period to evaluate their capacity for physical activity and exercise. More than two thirds (67.8%) of patients achieved therapeutic success, defined as a 10-point increase in their PF-10 score. Improvements were observed across all GOLD ii patient groups iii, with the greatest therapeutic success seen in symptomatic patients: 79.7% of patients classified as Group D achieved therapeutic success, as did 70.9% of patients classified as Group B. 1

In addition, the general condition of the patients was evaluated by the treating physician using the 8-point Physician’s Global Evaluation (PGE) scale. At the end of the study, 83.3% (6,016) of patients had ‘good to excellent’ general condition compared with 31.9% (2,302) at the start. 1

“Physical activity is an important part of the management of COPD. It is crucial that patients remain active, so they can achieve better long-term outcomes and enjoy a higher quality of life,” said Associate Professor Arschang Valipour, Ludwig Boltzmann Institute for COPD and Respiratory Epidemiology, Vienna, Austria, and Lead Investigator for the OTIVACTO trial. “We already know from clinical trials that tiotropium/olodaterol can make it easier for people with COPD to stay active by reducing symptoms and the difficulties related to physical activity. In this observational OTIVACTO study, we saw a similar effect; tiotropium/olodaterol increased patients’ ability to be active in their daily lives.”

Adherence to maintenance therapy is essential for therapeutic success in COPD. 2 The ability to properly inhale from the inhalation device plays a key role as it is important to transport the medication deep into the lungs where it can reach the small airways. 3,4 In the OTIVACTO study, more than 80% of patients were satisfied or very satisfied with both their inhalation experience and the handling of their Respimat ® device, as well as with tiotropium/olodaterol treatment overall. 1

“Real-world data complement the evidence from clinical trials and help us understand the effects of a medicine in everyday clinical practice. This in turn helps inform physicians’ decisions for the management of their patients,” said Dr Alberto de la Hoz, Global Medical Lead COPD and Asthma, Therapeutic Area Respiratory at Boehringer Ingelheim. “The OTIVACTO study presented at the ERS International Congress showed that patients receiving tiotropium/olodaterol therapy reported improvement in their general condition and ability to better manage their daily routines. It also showed high patient satisfaction with the Respimat ® device, both for inhaling and handling.”

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.

For references and notes to editors, please visit: http://www.boehringer-ingelheim.com/press-release/real-world-study-reports-effects-spiolto-respimat

i PF-10 is a sub-set of the validated SF-36 patient–reported quality-of-life questionnaire ii Global Initiative for Chronic Obstructive Lung Disease iii GOLD guideline uses a combined COPD assessment approach to group patients according to symptoms and previous history of exacerbations: GOLD A: Low symptom severity, low exacerbation risk GOLD B: High symptom severity, low exacerbation risk GOLD C: Low symptom severity, high exacerbation risk GOLD D: High symptom severity, high exacerbation risk

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KEYWORD: EUROPE GERMANY

INDUSTRY KEYWORD: HEALTH CLINICAL TRIALS MEDICAL DEVICES PHARMACEUTICAL RESEARCH SCIENCE

SOURCE: Boehringer Ingelheim

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PUB: 09/17/2018 03:00 AM/DISC: 09/17/2018 03:00 AM

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