New Analyses: Adding SPIRIVA^® RESPIMAT^® (tiotropium bromide) Inhalation Spray Effective for Uncontrolled Asthma – Regardless of Allergy Subtype

RIDGEFIELD, Conn., and Los Angeles, March 7, 2016 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced the presentation of new post-hoc analyses that show the addition of SPIRIVA^® RESPIMAT^® to other asthma maintenance therapies helps improve lung function and asthma symptom control, while reducing asthma exacerbations (also known as flare-ups), independent of a patient’s subtype of allergic asthma. These data were presented at the 2016 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Los Angeles.

These analyses evaluated the safety and efficacy of adding SPIRIVA^® RESPIMAT^® to other maintenance therapies compared to placebo across the broad range of asthma patients studied, regardless of immunoglobulin E (IgE) or eosinophil levels.

The addition of SPIRIVA^® RESPIMAT^® significantly improved lung function*. Adding SPIRIVA^® RESPIMAT^® also was shown to improve asthma symptom control, as measured by the seven question Asthma Control Questionnaire (ACQ-7) and reduce the risk of asthma worsening and exacerbations^†. The ACQ-7 results in the pooled analysis did not distinguish among the treatment arms.

“The data confirm that adding SPIRIVA^® RESPIMAT^® is a well-tolerated and effective treatment option for asthma patients independent of allergic subtype,” said Mark Vandewalker, MD, director, Clinical Research of the Ozarks, Columbia, Missouri. “For people with allergic asthma who are still experiencing symptoms, adding SPIRIVA^® RESPIMAT^® may help open airways to improve breathing.”

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

SPIRIVA^® RESPIMAT^® is steroid-free and works differently than other therapies. When asthma symptoms persist despite taking other maintenance therapies, adding SPIRIVA^® RESPIMAT^® may help people breathe better by opening constricted airways.

SPIRIVA^® RESPIMAT^® is the first new class of inhaled medicine approved in over 10 years for asthma. The U.S. Food and Drug Administration (FDA) approved a once-daily dose of SPIRIVA^® RESPIMAT^® 2.5 µg (delivered in 2 puffs of 1.25 µg each) for the long-term maintenance treatment of asthma in people ages 12 and older. SPIRIVA^® RESPIMAT^® is not a treatment for sudden asthma symptoms. In the treatment of asthma, the maximum benefits in lung function may take up to 4 to 8 weeks of dosing.

“Boehringer Ingelheim is committed to pursuing scientific research to help address unmet needs and improve patient care for people living with asthma,” said Danny McBryan, MD, vice president, Clinical Development & Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. “These data further demonstrate the benefits of SPIRIVA^® RESPIMAT^® for the broad range of asthma patients studied who continued to experience symptoms despite taking other maintenance therapies, regardless of allergy subtype.”

The post-hoc analyses are based on data from the two PrimoTinA-asthma^® and two MezzoTinA-asthma^® trials which are part of the UniTinA-asthma^® large-scale clinical trial programme:

• The PrimoTinA-asthma^® trials investigated SPIRIVA^® RESPIMAT^® as an add-on therapy for adults with asthma who continued to have symptoms despite taking at least ICS/LABA therapy.
• The MezzoTinA-asthma^® trials investigated SPIRIVA^® RESPIMAT^® as an add-on therapy for adults with asthma who continued to have symptoms despite taking at least moderate-dose ICS therapy.

The safety and tolerability of SPIRIVA^® RESPIMAT^® in each trial and treatment group were comparable with those of placebo in the overall patient population.

For additional information, please visit https://www.spiriva.com/asthma.

About the RESPIMAT Inhaler
The RESPIMAT^® is the platform inhaler for the Boehringer Ingelheim respiratory therapies. The RESPIMAT^® is the only inhaler that actively delivers a slow-moving mist that helps patients inhale the medication. 

The RESPIMAT^® inhaler delivers medication independent of the degree or strength of inspiratory 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).

Indication

SPIRIVA^® RESPIMAT^®, 1.25 µg per actuation, 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 symptoms of 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, 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information for SPIRIVA RESPIMAT, including Instructions for Use.

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.

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 146 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 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 2014, Boehringer Ingelheim achieved net sales of about $16.96 billion dollars (13.3 billion euros). R&D expenditure corresponds to 19.9 percent of its net sales.

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

 

PR-SVRA-0025