First Phase III Data for Tiotropium in Symptomatic Asthma Patients Treated with ICS/LABA Published in the New England Journal of Medicine

VIENNA, Sept. 3, 2012 /PRNewswire/ -- Boehringer Ingelheim presented today the first data from the Phase III UniTinA-asthma™ program. In two studies, presented at the 2012 European Respiratory Society (ERS) Congress in Vienna, Austria, tiotropium delivered once daily via the Respimat® inhaler significantly improved lung function and reduced asthma exacerbations in patients who remained symptomatic on current treatment with at least high dose inhaled corticosteroids (ICS) and long-acting beta agonists (LABA). This data was simultaneously published online in the New England Journal of Medicine.

The two PrimoTinA-asthma™ studies were replicate double-blind parallel-group trials including asthma patients with post-bronchodilator FEV₁ <80% predicted and asthma control questionnaire score >/= 1.5 while on at least high dose ICS/LABA. A total of 912 patients were randomized to receive tiotropium 5 microgram or placebo in addition to usual care for 48 weeks.

The pre-specified co-primary lung function endpoints included peak and trough FEV₁ at 24 weeks. Adding tiotropium provided significant lung function improvements at 24 weeks (mean change from baseline tiotropium vs placebo (plus or minus standard error): peak FEV₁ trial 1: 86 (plus or minus 34) mL (P=0.01), trial 2: 154 (plus or minus 32) mL greater (P<0.001); trough FEV₁  trial 1: 88 (plus or minus 34) mL (P=0.01), trial 2: 111 (plus or minus 30) mL greater (P<0.001)), which were sustained over 48 weeks.

For the third co-primary endpoint, in the pre-specified combined analysis of the two trials, the addition of tiotropium was associated with a 21% risk reduction (HR 0.79, P=0.03) in time to first severe exacerbation at 48 weeks. Severe exacerbations were defined as requiring systemic corticosteroids for at least 3 days and a decrease in lung function.

The addition of tiotropium also reduced the risk of any asthma exacerbation by 31% (P<0.0001), defined by a significant increase in symptoms or peak expiratory flow (PEF) drop >/= 30% over >/= 2 days.

There were also improved scores observed in the asthma control questionnaire (ACQ) and the asthma quality of life questionnaire in one trial, and a trend towards improvement in the ACQ in the other study.

In these studies, the rate of adverse events reported in the tiotropium add-on and placebo add-on groups was similar. The most commonly reported adverse events were nasopharyngitis and headache.

"These first Phase III results from the UniTinA-asthma™ program are encouraging based on their potential to provide a new treatment option for adults with asthma, approximately half of whom remain symptomatic despite current treatment options and may be suffering from asthma exacerbations," said Tunde Otulana, MD, Vice President, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. "We are committed to evaluating tiotropium in a wide range of asthma patients."

About UniTinA-Asthma™
The PrimoTinA-asthma™ studies are a part of the comprehensive Phase III trial program UniTinA-asthma™, which includes a number of clinical trials in adults, adolescents and pediatric patients across different asthma severities who remain symptomatic/uncontrolled on current treatment with inhaled corticosteroids. The program includes over 4,000 patients in more than 150 sites globally.

About Asthma
Asthma is a chronic disease characterized by airway inflammation and bronchoconstriction. When a person with asthma comes into contact with an asthma trigger (e.g. infections, pollen, smoke), their airways can become inflamed, swollen and constricted and excess mucus is produced. These reactions can cause the airways to become narrower and irritated, making it difficult to breathe. People suffering from asthma experience recurrent episodes of wheezing, breathlessness, chest tightness and coughing.

As of May 2011, an estimated 235 million people worldwide suffer from asthma. Estimates have shown that the number of people with asthma could grow to as many as 400-450 million people worldwide by 2025.

By avoiding asthma triggers, one can help to reduce the severity of asthma. Although asthma cannot be cured, appropriate management can control the disease in many patients. However, many patients still suffer from uncontrolled asthma despite the available treatment options. They can continue to have symptoms and lifestyle restrictions and might even require emergency care.

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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SOURCE Boehringer Ingelheim