Boehringer Ingelheim Presents Efficacy Data for Tiotropium in Symptomatic Asthma Patients in Relation to Allergic Status

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Data presented at the 2013 American Academy of Allergy, Asthma & Immunology
Annual Meeting
SAN ANTONIO, Feb. 23, 2013 /PRNewswire/ -- Boehringer Ingelheim presented
today a new subset of data from the Phase III UniTinA-asthma program at the
2013 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in
San Antonio, Texas. In prespecified subgroups from two paired clinical trials,
tiotropium delivered once daily via the Respimat inhaler improved lung function
and asthma control, as defined by a decrease in asthma exacerbations or
worsening of asthma, in patients with poorly controlled asthma, irrespective of
their allergic status. Patients included in the study remained symptomatic
despite current treatment with at least high dose inhaled corticosteroids (ICS)
and long-acting beta agonists (LABA).

"Patients with asthma may respond differently to treatment based on their
allergic status, therefore it is important to investigate new therapies in both
allergic and non-allergic patients," said Mark Vandewalker, MD, director,
Clinical Research of the Ozarks, Columbia, Missouri. "The results of these
trials show that tiotropium provides additional bronchodilation and reduces
exacerbation rates in asthmatics who are uncontrolled on current therapy with at
least ICS/LABA regardless of their allergic status, thus demonstrating its
potential benefit for patients who need additional asthma control."

The two PrimoTinA-asthma studies were replicate double-blind parallel-group
trials including asthma patients with post-bronchodilator FEV1 less than 80
percent predicted and asthma control questionnaire score of greater than or
equal to 1.5, while on at least high dose ICS/LABA. A total of 912 patients were
randomized to receive tiotropium 5 mcg or placebo in addition to usual care for
48 weeks. In addition to ICS/LABA, patients in the trials were permitted to
receive additional background therapy, including antihistamines, anti-allergic
agents, nasal steroids and omalizumab. The subgroup of patients with potentially
allergic asthma was identified using three criteria: total serum immunoglobulin
E (IgE), blood eosinophilia, or clinician judgment (CJ). Allergic status was
positive if serum IgE was greater than 430 mcg/L, blood eosinophilia was greater
than 0.6 x 109/L, or CJ was "yes."

Peak FEV1 improved with tiotropium in Trial 1 irrespective of allergic status
for IgE (P=0.86) and eosinophilia (P=0.46) and in Trial 2 for IgE (P=0.98),
eosinophilia (P=0.18) and CJ (P=0.29). Predose (trough) FEV1 improved with
tiotropium compared with placebo, irrespective of allergic status, across all
criteria in Trial 1 (IgE, P=0.85; eosinophilia, P=0.83; and CJ, P=0.15) and
Trial 2 (IgE, P=0.58; eosinophilia, P=0.38; and CJ, P=0.85). Pooled
prespecified data analyses revealed that time to first severe asthma
exacerbation and time to first asthma worsening were both increased with
tiotropium compared with placebo, regardless of allergic status, based on the
three criteria. In the overall study population, patients who received
tiotropium had an improved time to first severe asthma exacerbation (risk
reduction 21 percent; hazard ratio [HR] 0.79; P=0.03) and time to first asthma
worsening (risk reduction 31 percent; HR 0.69; P<0.001), compared with patients
receiving placebo.

Adverse events (AEs) were balanced between the allergic and non-allergic
subgroups. The most frequently reported treatment-emergent AEs in both Phase III
studies included asthma, peak expiratory flow (PEF) rate decrease and
nasopharyngitis.

"Through the UniTinA-Asthma program, our goal is to evaluate tiotropium in a
wide range of asthma patients to determine where there may be a benefit," said
Tunde Otulana, MD, vice president, Clinical Development and Medical Affairs,
Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. "We are encouraged by
these findings, as they provide us with more information on tiotropium's
potential across new subsets 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 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 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 by an
additional 100 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 percent of its net sales.

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SOURCE Boehringer Ingelheim

Jennifer Forsyth, Boehringer Ingelheim, +1-203-791-5889,
usnews@boehringeringelheim.com