New Phase III Data in Asthma Patients Show Tiotropium Improves Lung Function, Regardless of Allergic Status

HOUSTON, Feb. 21, 2015 /PRNewswire/ -- Boehringer Ingelheim today presented data on investigational tiotropium delivered via Respimat® inhaler from five Phase III trials from the UniTinA-asthma® program at the 2015 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Houston, Texas. Pre-planned analyses from the program, including new data from the GraziaTinA study, showed that the addition of tiotropium Respimat in adult patients with mild, moderate and severe asthma who continue to experience symptoms despite the use of maintenance therapies, improved lung function as measured by peak forced expiratory volume in one second (FEV_{1 (0-3hr)}) and trough FEV₁, independent of underlying allergic status. Tiotropium is being investigated to determine its efficacy and safety in treating asthma patients and is not currently approved for this indication.

"A significant number of asthma patients continue to experience symptoms despite treatment with available therapies and it is important to understand how a patient's allergic status might impact their response to treatment," said Kevin Murphy, MD, Boys Town National Research Hospital, Omaha, Nebraska. "These data showed that the addition of tiotropium delivered via Respimat inhaler improved lung function in adults with asthma across a range of severities independent of underlying allergic status."

Tiotropium is being studied as a once-daily, add-on treatment in asthma patients who continue to experience symptoms (e.g., wheezing, shortness of breath, chest tightness and cough), despite the use of maintenance therapy including inhaled corticosteroids (ICS) with or without long-acting beta agonists (LABA). The studies included in these analyses were double-blind, placebo-controlled, parallel-group trials in adult patients with mild, moderate and severe asthma. A total of 3,480 patients were randomized for the five trials to receive tiotropium 5 mcg, 2.5 mcg or placebo in addition to ICS with or without LABA. Three criteria were used to determine whether or not a patient had allergies: total serum immunoglobulin E (IgE, < or =430mcg/L [equivalent to 179.2 IU/L]), blood eosinophils (< or =0.6×10⁹/L), or investigator judgment (No/Yes). Patients were permitted to receive additional background therapy, which varied from trial to trial, and included treatments such as antihistamines, anti-allergic agents, nasal steroids and omalizumab.

The Phase III studies included in these analyses were:

• Two PrimoTinA-asthma® trials (NCT00772538/NCT00776984) in patients with severe asthma who remained symptomatic while receiving high-dose ICS therapy plus LABA therapy
• Two MezzoTinA-asthma® trials (NCT01172808/NCT01172821) in patients with moderate asthma who remained symptomatic while receiving medium-dose ICS therapy
• One GraziaTinA-asthma trial (NCT01316380) in patients with mild asthma who remained symptomatic while receiving low-dose ICS treatment

Peak FEV_{1 (0-3hr)} and trough FEV₁ significantly improved with the addition of tiotropium delivered via the Respimat inhaler compared to placebo, irrespective of underlying allergic status.

The adverse event (AE) data presented is pooled from the five Phase III trials in adults. The most commonly reported AEs, by preferred term, from the pooled analyses were asthma, bronchitis, decreased peak expiratory flow rate, headache, nasopharyngitis and upper respiratory tract infection.

"Allergic asthma is the most common form of asthma and new and additional treatment options are needed to help manage this disease," said Danny McBryan, MD, vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. "These data add to our understanding of the safety and efficacy of adding tiotropium to maintenance therapies in patients who remain symptomatic despite available asthma treatments."

About UniTinA-Asthma®
The comprehensive Phase III trial program, UniTinA-asthma, includes a number of clinical trials that evaluated tiotropium delivered via Respimat inhaler as add-on treatment for adults, adolescents and pediatric patients across different asthma severities who remain symptomatic on current treatment with ICS with or without LABA. The program includes more than 6,000 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. Asthma attacks occur when symptoms become more intense or frequent.

As of December 2012, an estimated 300 million people worldwide suffer from asthma. Estimates have shown that the number of people with asthma could grow by an additional 100 million people worldwide by 2025.

Although asthma cannot be cured, appropriate management can control the disease in many patients. Despite current treatment options, approximately 40 percent of patients with asthma remain symptomatic.

Leading Respiratory Forward
Through research, Boehringer Ingelheim (BI) has developed drug therapies to help patients with lung diseases. 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 help patients with COPD, asthma, lung cancer, and idiopathic pulmonary fibrosis.

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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