Boehringer Ingelheim Presents First Phase 3 Data on Fixed-Dose Combination of Tiotropium Plus Olodaterol in COPD

RIDGEFIELD, Conn., May 21, 2014 /PRNewswire/ -- Boehringer Ingelheim today presented results of the VIVACITO^® (NCT01559116) study, the first Phase 3 data to be reported from the TOviTO^® clinical trial program, evaluating the effect of the fixed-dose combination of tiotropium and olodaterol (T+O FDC) delivered via the Respimat^® inhaler on lung function in people with chronic obstructive pulmonary disease (COPD). These data were presented as a late-breaking poster at the American Thoracic Society (ATS) 2014 International Conference.

Once-daily T+O FDC is an investigational treatment that combines the long-acting muscarinic antagonist (LAMA) tiotropium with olodaterol, an investigational long-acting beta agonist (LABA), delivered via the Respimat^® inhaler, a propellant-free inhaler that generates a soft, slow-moving mist. The Phase 3 clinical trial program for T+O FDC, TOviTO^®, is a large global program that includes more than 8,000 patients with COPD.

"The improvement in lung function seen in the VIVACITO^® study suggests that T+O FDC has the potential to become a viable once-daily COPD treatment," said Klaus F. Rabe, Professor of Pulmonary Medicine at the University of Kiel and Director of the Department of Pneumology at Clinic Grosshansdorf in Germany. "This is good news as we have learned that not all patients respond to just one therapy and more options are needed, particularly considering the incidence of COPD is projected to increase worldwide in the coming decades."

VIVACITO^® was a Phase 3 study in which 219 patients with moderate to very severe COPD were randomized to receive four of the following treatments for six weeks, each with a three-week period of no treatment in between: (1) placebo; (2) olodaterol 5 mcg; (3) tiotropium 2.5 mcg or tiotropium 5 mcg; (4) T+O FDC 2.5/5 mcg or T+O FDC 5/5 mcg. The primary endpoint was forced expiratory volume in one second (FEV₁), a measure of the amount of air exhaled in one second, over 24 hours after six weeks of treatment. Secondary endpoints included additional tests measuring breathing over 24 hours.

The 24-hour time profiles for both FDCs were very similar and showed improvements in lung function, as measured by FEV₁, compared with placebo and monotherapies over 24 hours. Both T+O FDCs were statistically significantly superior to placebo.

Additionally, trough FEV₁ was measured as a secondary endpoint. Results showed increases in lung function at the end of the 24-hour dosing interval for the two T+O FDCs versus placebo and monotherapies.

The overall incidence of adverse events (AEs) was comparable between treatment groups: 46.4 percent with placebo, 37.7 percent with olodaterol 5 mcg, 39.4 percent with tiotropium 2.5 mcg, 44.2 percent with tiotropium 5 mcg, 36.0 percent for the T+O FDC 2.5/5 mcg, and 37.4 percent with T+O FDC 5/5 mcg. The most common individual AEs were nasopharyngitis and worsening of COPD.

"As a leading provider of COPD treatment for the last decade, we are excited by these first data from TOviTO^®, our extensive clinical trial program for the tiotropium plus olodaterol fixed-dose combination, and look forward to presenting additional trial results later this year," said Tunde Otulana, MD, senior vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Today, Boehringer Ingelheim has a diverse respiratory pipeline that includes several exciting developments for tiotropium." 

Results from the pivotal 52-week Phase 3 TONADO^® 1&2 trials, investigating the long-term effect of T+O FDC on lung function and quality of life in patients with COPD, are forthcoming.

About COPD
Chronic obstructive pulmonary disease (COPD) includes 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 26 million Americans may have COPD – even those who haven't smoked in years – and nearly half of them remain undiagnosed. COPD is the third leading cause of death in the United States. It kills one person every four minutes in the United States.

Common symptoms of COPD include shortness of breath and coughing with or without excess mucus.

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 142 affiliates and more than 47,400 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.

Social responsibility is a central element of Boehringer Ingelheim's culture. 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 2013, Boehringer Ingelheim achieved net sales of about $18.7 billion (14.1 billion euro). R&D expenditure in the Prescription Medicines business corresponds to 19.5% of its net sales.

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