New Analyses Show SPIRIVA^® RESPIMAT^® (tiotropium bromide) Inhalation Spray Improves Breathing for People with Asthma Regardless of BMI or Allergic Status

Ridgefield, Conn., May 23, 2017 - Boehringer Ingelheim today announced new analyses that provide further evidence that adding SPIRIVA RESPIMAT improved breathing across diverse patient populations who experience uncontrolled asthma symptoms despite the use of another daily maintenance therapy in the Phase III clinical development program. These data analyses will be presented today at the American Thoracic Society International Conference in Washington, D.C.

“Many people with asthma continue to live with uncontrolled symptoms. These new analyses show that adding SPIRIVA RESPIMAT to another maintenance treatment may improve breathing, even for people whose symptoms may be harder to control, such as those with higher body mass index or people who have both asthma and allergies,” said Danny McBryan, MD, Head of Clinical Development & Medical Affairs, COPD & Asthma, Boehringer Ingelheim Pharmaceuticals, Inc. “These analyses are examples of Boehringer Ingelheim’s commitment to scientific research that helps improve understanding of who may best benefit from our medicines.”

People with allergic asthma – the most common form of the condition – can experience inflammation and a tightening of the airways when exposed to common allergens. These patients may need other options that complement their existing therapy.

Data Analyses
Two new analyses show SPIRIVA RESPIMAT improved lung function in children and adolescents with moderate to severe asthma, regardless of their allergic status.

In the post hoc analyses of several Phase III randomized, double-blind, placebo controlled studies in pediatric and adolescent patients with moderate to severe asthma, adding SPIRIVA RESPIMAT improved peak FEV₁(0-3h) and trough FEV₁ across a range of baseline immunoglobulin E (IgE) levels and eosinophil counts, compared to placebo. Adding SPIRIVA RESPIMAT also reduced the risk of exacerbations compared to placebo, in pediatric and adolescent patients, regardless of baseline IgE levels and blood eosinophil counts.

A separate subgroup analysis showed that adding SPIRIVA RESPIMAT was effective at reducing symptoms and improving lung function in adults with mild to severe asthma in all BMI categories, including those who were overweight or obese, a population that often experiences symptoms that are harder to control. The data showed that adding SPIRIVA RESPIMAT improved peak FEV₁(0-3h) and trough FEV₁ in adult patients with mild to severe asthma compared to placebo, regardless of their BMI.

“Asthma affects many types of people, and everyone has their own allergic status and body mass index ranking. This research shows that SPIRIVA RESPIMAT may be an effective treatment option – with a well characterized safety profile – for diverse patient populations who may still be experiencing uncontrolled asthma symptoms,” said Mark Vandewalker, MD, director, Clinical Research of the Ozarks, Columbia, Missouri. “As an asthma specialist, I am encouraged to see further evidence suggesting that adding SPIRIVA RESPIMAT helped to control symptoms in many kinds of asthmatics who were already taking an ICS or ICS/LABA combination.”

SPIRIVA RESPIMAT is steroid-free and works differently from other treatment options to open airways to help people breathe better. SPIRIVA RESPIMAT is part of a class of medicines called long-acting muscarinic antagonist (LAMA) and is the only one approved for the treatment of asthma.

SPIRIVA RESPIMAT, 1.25 mcg, is a long-term, once-daily, prescription maintenance treatment of asthma for people 6 years and older. SPIRIVA RESPIMAT is not a treatment for sudden asthma symptoms.

About Asthma
More than 24 million people in the U.S. have asthma, including 6.3 million children under the age of 18. Asthma is a chronic disease and despite taking maintenance treatments, many children and adults continue to have uncontrolled asthma. According to the CDC, 50 percent of adults and over 38 percent of children with asthma in the U.S. remain symptomatic, despite maintenance treatment.

When a person with asthma comes into contact with an asthma trigger (e.g., infections, pollen, and 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.

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, headache, bronchitis, and sinus infection. The side effect profile for adolescent and pediatric patients was comparable to that observed in adult patients with asthma. 

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.

Indication
SPIRIVA RESPIMAT, 1.25 mcg, is a long-term, once-daily, prescription maintenance treatment of asthma for people 6 years and older. SPIRIVA RESPIMAT is not a treatment for sudden asthma symptoms. 

Please see full Prescribing Information and Instructions for Use for SPIRIVA RESPIMAT.

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 top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

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. Please visit our website to learn more about how we make more health for more people through our Corporate Social Responsibility initiatives.

In 2016, Boehringer Ingelheim achieved net sales of about $17.6 billion (15.9 billion euros). R&D expenditure corresponds to 19.6 percent of its net sales.

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

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