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Boehringer Ingelheim Presents First Data for Tiotropium in Adolescents with Moderate Persistent Asthma

SAN FRANCISCO, May 22, 2012 /PRNewswire/ -- Boehringer Ingelheim announced today results from a Phase II study evaluating the investigational compound tiotropium delivered once-daily via the Respimat® Inhaler in adolescents with symptomatic, moderate persistent asthma. The data were presented at the 2012 Annual Meeting of the American Thoracic Society (ATS 2012). Boehringer Ingelheim announced that a comprehensive confirmatory Phase III trial program named UniTinA-asthma™ is ongoing to fully evaluate the potential of the long-acting bronchodilator in the treatment of asthma in pediatric, adolescent and adult patients. 

The results are from a Phase II, 4-week, randomized, double-blind, placebo-controlled, incomplete cross-over study. This dose-ranging study evaluated 105 patients 12 to 17 years of age with moderate, persistent asthma on medium dose inhaled corticosteroids (ICS) with or without long-acting beta-agonist (LABA) or leukotriene receptor antagonists (LTRA). 

With all dosages of tiotropium administered once daily, lung function was greater as evaluated by peak FEV1(0-3h) (1.25 microgram = 0.566 L; 2.5 microgram = 0.546 L; 5 microgram = 0.602 L), 1.25FEV1AUC(0-3h)  (1.25 microgram = 0.455 L; 2.5 microgram = 0.434 L; 5 microgram = 0.497 L) and trough FEV1 (1.25 microgram = 0.384 L; 2.5 microgram = 0.353 L; 5 microgram = 0.442 L) compared to placebo (0.489 L, 0.363 L, 0.292 L, respectively). A statistically significant increase in lung function was observed with 5 microgram tiotropium administered once daily (peak FEV1(0-3h)  = 0.113 L, p = 0.004; FEV1AUC(0-3h) = 0.133 L, p<0.001;  trough FEV1 = 0.151 L, p<0.001). The 5 microgram dose was chosen for further studies of tiotropium in this patient population.

"Despite substantial advancements in the treatment of asthma and a wide range of available therapeutic options, a significant number of patients still remain symptomatic," said Dr. Christian Vogelberg, of University Children's Hospital, Dresden, Germany and lead author of the study. "As the first available data looking at tiotropium in adolescents with asthma, these results warrant further investigation into the utility of tiotropium when added to inhaled corticosteroids in this patient population."

The most commonly reported adverse events included nasopharyngitis and asthma. These results are consistent with the previous Phase II proof of concept studies demonstrating clinical activity of tiotropium in adult patients with asthma.

"We are encouraged by these Phase II trial results in moderate, persistent asthma as we continue our Phase III clinical trial program," said Tunde Otulana, MD, Vice President, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. "Our goal is to develop a treatment option for patients who still experience asthma symptoms on current therapy."

About UniTinA-Asthma™
The comprehensive Phase III trial program UniTinA-asthma™ 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 characterised 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 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, a significant number of patients suffer from uncontrolled asthma despite the available treatment options.  They can continue to have symptoms and lifestyle restrictions and might even require emergency care.

Boehringer Ingelheim: Leading respiratory forward
Treatment of respiratory diseases has been a major area of focus for Boehringer Ingelheim for over 90 years and significant resources are dedicated to research in this field. In addition to new possible treatments for asthma, Boehringer Ingelheim has also branched out into developing potential treatment options for other airway diseases, including COPD, 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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