Tiotropium RESPIMAT^® Improved Lung Function with Safety Comparable to Placebo in Children with Asthma

RIDGEFIELD, Conn., September 6, 2016 - Boehringer Ingelheim announced today new study results from the Phase III CanoTinA-asthma trial that showed adding tiotropium RESPIMAT to maintenance asthma therapy, in children aged 6-11, significantly improved lung function, as measured by forced expiratory volume in one second measured from 0 to 3 hours after dosing (FEV1(0-3h)), compared to placebo (p<0.0001). These findings were presented today at the European Respiratory Society (ERS) International Congress 2016 in London.

The trial investigated tiotropium RESPIMAT as an add-on therapy for children who were already taking an inhaled corticosteroid (ICS), or an ICS combined with other maintenance therapy. In this study, the safety and tolerability of tiotropium RESPIMAT were shown to be comparable to placebo.

“Asthma is the most common chronic childhood disease, but many children still continue to experience asthma symptoms despite taking other maintenance therapies,” said Professor Christian Vogelberg, University Children’s Hospital Dresden, Germany. “These new results showed significant lung function improvements for children with asthma and importantly confirm that the safety profile of tiotropium RESPIMAT in children aged one year and above is comparable to placebo.”

A new pooled analysis from four studies, VivaTinA-asthma^®, RubaTinA-asthma^®, PensieTinA-asthma^® and CanoTinA-asthma also presented at ERS showed adding tiotropium RESPIMAT to maintenance therapy for children aged 6-17 years has a comparable safety profile to placebo. In addition, this analysis showed tiotropium RESPIMAT improved peak expiratory flow (PEF), a common measure of asthma control, in participants aged 6-17 years.

A further analysis presented from the NinoTinA-asthma^® trial showed the safety profile of adding tiotropium RESPIMAT to maintenance therapy among children aged 1-5 is consistent with that found in older children and adults.

The CanoTinA-asthma (NCT01634139), NinoTinA-asthma (NCT01634113), VivaTinA-asthma (NCT01634152), RubaTinA-asthma (NCT01257230) and PensieTinA-asthma (NCT01277523) trials are part of the 18 clinical studies from the Phase II and Phase III UniTinA-asthma^® clinical development program, which included more than 150 sites globally with over 6,000 patients, including over 1,800 children and adolescents aged 1-17 years.

“At Boehringer Ingelheim, we have a strong commitment to scientific research with the goal of improving the care of people living with serious respiratory diseases, such as asthma,” said Dr. William Mezzanotte, Vice President and Head of Respiratory Medicine at Boehringer Ingelheim. “Data from these studies build on the body of evidence that we have learned about tiotropium RESPIMAT as an asthma therapy.”

In the U.S., SPIRIVA^® RESPIMAT^® (tiotropium bromide) Inhalation Spray (1.25mcg/puff, 2 puffs, once daily) is approved for the long-term maintenance treatment of asthma in people ages 12 and older. SPIRIVA RESPIMAT is not a treatment for sudden asthma symptoms.

Tiotropium is an inhaled long-acting, anticholinergic bronchodilator. It works by opening airways and helps to keep them open for at least 24 hours.

About Asthma
More than 22 million people in the U.S. have asthma. Asthma is a chronic disease and in the U.S., many patients taking currently available asthma treatments continue to experience symptoms. In a web-based survey of 1,812 asthma patients, 55 percent of patients taking asthma treatment still remained uncontrolled.

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.

About the RESPIMAT Inhaler
RESPIMAT, the platform inhaler for the Boehringer Ingelheim respiratory therapies, was designed to get medicine deep into patients’ lungs as a slow-moving mist. The slow moving mist of the RESPIMAT inhaler provides patients with enough time to breathe in the medication. The RESPIMAT inhaler operates independent of inspiratory effort, helping patients effectively breathe the medicine into their lungs while minimizing inhalation effort.

As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as coordination between actuation of the inhaler and inspiration through the delivery system. The duration of inhalation should be at least as long as the spray duration (1.5 seconds).

Boehringer Ingelheim’s RESPIMAT family of products includes five FDA-approved medicines for COPD and asthma.

Indication

SPIRIVA RESPIMAT, 1.25 mcg, is a long-term, once-daily, prescription maintenance treatment of asthma for people 12 years and older. SPIRIVA RESPIMAT is not a treatment for sudden asthma symptoms. 

Important Safety Information

Do not use SPIRIVA RESPIMAT (tiotropium bromide) Inhalation Spray if you are allergic to tiotropium, ipratropium, atropine or similar drugs, or any ingredient in this medicine.

SPIRIVA RESPIMAT is not a rescue medicine and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems.

SPIRIVA RESPIMAT can cause allergic reactions. Symptoms can include raised red patches on your skin (hives), itching, rash and/or swelling of the lips, tongue, or throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking the medicine and seek emergency medical care.

SPIRIVA RESPIMAT can cause your breathing to suddenly get worse (bronchospasm). If this happens, use your rescue inhaler, stop taking SPIRIVA RESPIMAT, and call your doctor right away or seek emergency medical care.

SPIRIVA RESPIMAT can increase the pressure in your eyes (acute narrow-angle glaucoma), which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

Dizziness and blurred vision may occur with SPIRIVA RESPIMAT. If you experience these symptoms, use caution when engaging in activities such as driving a car, or operating appliances or machinery.

SPIRIVA RESPIMAT can cause new or worsened urinary retention. Symptoms of blockage in your bladder and/or enlarged prostate may include difficulty passing urine and/or painful urination. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

The most common side effects with SPIRIVA RESPIMAT in adult patients with asthma were sore throat, sinus infection, bronchitis, and headache.

Do not spray SPIRIVA RESPIMAT into your eyes, as this may cause blurring of vision and pupil dilation.

Tell your doctor about all your medical conditions including kidney problems, glaucoma, enlarged prostate, problems passing urine, or blockage in your bladder.

Tell your doctor all the medicines you take, including eye drops. Ask your doctor if you are taking any anticholinergic medicines because taking them together with SPIRIVA RESPIMAT can increase side effects.

Please see full Prescribing Information for SPIRIVA RESPIMAT.

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.

Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

In 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales.

For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.

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