Boehringer Ingelheim Presents First Results of Phase II Study of Investigational COPD Combination

The Phase II dose-finding study is a randomized, double-blind, 4-period, incomplete crossover trial of 4 weeks duration involving 232 COPD patients with post-bronchodilator FEV₁ of >/= 30% and <80% of predicted normal. To assist in the development of the fixed-dose combination, various doses of tiotropium (1.25, 2.5 and 5 microgram) were tested in combination with either olodaterol 5 microgram or 10 microgram and efficacy was measured against the respective doses of olodaterol as monotherapy. Both treatments were delivered via the Respimat^® inhaler.

The study compared pre-dose (trough) lung function and lung function up to 6 hours post-dose after 4 weeks treatment with tiotropium and olodaterol as a free combination versus olodaterol as a monotherapy. Significant improvements were seen for all combinations of doses tested (tiotropium 1.25, 2.5 and 5 microgram / olodaterol 5 microgram, 10 microgram) compared with the respective olodaterol monotherapies.

After 4 weeks of treatment, the free combination of tiotropium and olodaterol provided an average lung function improvement of up to 342 mL over the first 6 hours (FEV₁ AUC_0-6) compared to pre-dose lung function mean baseline values and improvements in trough FEV₁^* of up to 166 mL, compared to pre-treatment FEV₁ mean baseline values.

No safety or tolerability concerns were identified beyond what is known for the components. Treatment with both olodaterol monotherapy and combinations of tiotropium/olodaterol once daily was generally well tolerated within this small study population. Adverse events seen in greater than 5% of patients in any treatment group were nasopharyngitis and COPD.  

"Boehringer Ingelheim conducted a comprehensive Phase II program investigating different doses of each active component to identify the optimal doses for the combination," said Tunde Otulana, MD, Vice President, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. "We are committed to the clinical development program of olodaterol and the combination with tiotropium in order to identify new treatment options for patients with COPD."

About the Phase III TOviTO® Program
The TOviTO^® program, one of the largest global Phase III clinical trial programs ever conducted in COPD, is evaluating the potential benefits of tiotropium and olodaterol in a once-daily fixed-dose combination using the Respimat^® inhaler in the treatment of patients with COPD. It consists of several Phase III studies including the two pivotal registration trials TOnado 1&2, which are multi-centered, multi-national, randomized, double-blind, parallel group studies randomizing a total of 5,000 COPD patients across the spectrum of disease severity from GOLD Stage II to GOLD Stage IV at more than 500 trial sites in approximately 40 countries.

In addition to evaluating the effects of tiotropium + olodaterol FDC on lung function, the TOviTO^® program also focuses on the evaluation of other important clinical outcomes that reflect the daily life of patients with COPD.

About COPD
Chronic obstructive pulmonary disease (COPD) is also known as chronic bronchitis and emphysema. This disease makes it harder to breathe because less air is able to flow in and out of the lungs. As many as 24 million Americans may have COPD – even those who haven't smoked in years – and half of them remain undiagnosed. COPD is the fourth leading cause of death in the United States. It kills one person every four minutes in the United States.

Common symptoms of COPD include coughing with excess mucus or shortness of breath.

Leading respiratory forward
Through research, treatments and patient-centric support services, the Boehringer Ingelheim (BI) lung health portfolio is designed to help address the challenges people living with a lung disease face every day. Leveraging the company's cutting edge science and leadership in chronic obstructive pulmonary disease (COPD), BI is researching new treatment approaches where needs persist. It is the company's goal to make a difference in the lives of patients with COPD, asthma, lung cancer, idiopathic pulmonary fibrosis and other respiratory diseases.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. Subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act in a socially responsible manner. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2011, Boehringer Ingelheim achieved net sales of about $17.1 billion (13.2 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.

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[*] Trough FEV₁ is Forced Expiratory Volume in one second at the end of the dosing interval (at approximately 24 hours post-treatment administration)

SOURCE Boehringer Ingelheim