New Study Further Supports the Benefits of SPIRIVA RESPIMAT in the Treatment of Asthma

RIDGEFIELD, Conn., Feb. 3, 2020 /PRNewswire/ -- Boehringer Ingelheim today presented results from a new retrospective analysis of real-world data that showed patients prescribed Spiriva® Respimat® (tiotropium bromide) Inhalation Spray 1.25 mcg experienced fewer asthma-related exacerbations when Spiriva Respimat was added to a popular class of asthma treatments (combination inhaled corticosteroid and long-acting beta₂-agonist (ICS+LABA)) vs. patients receiving an increased dose of ICS+LABA. This new retrospective analysis of data from nearly 8,000 adults and adolescents with asthma was presented today at the Western Society of Allergy, Asthma and Immunology (WSAAI) 2020 Annual Scientific Session in Hawaii.

An asthma exacerbation, also known as an asthma attack, is characterized by coughing, wheezing, severe shortness of breath and chest tightness or pain. Symptoms can often be managed with prompt at-home therapy, but severe asthma exacerbations can become life-threatening and require emergency treatment.¹

The study found that when adding Spiriva Respimat to ICS+LABA treatment, patients had fewer exacerbations and hospitalizations compared to those receiving an increased dose of ICS+LABA or continuing on high-dose of ICS+LABA, ultimately meeting the study's primary endpoint. Results also met the two secondary endpoints by showing:ⁱ

• At 12 months, patients prescribed add-on Spiriva Respimat showed a 73% lower exacerbation rate compared to patients prescribed an increased dose of ICS+LABA
  
  
• At 12 months, patients prescribed add-on Spiriva Respimat showed a 76% lower hospitalization rate compared to patients prescribed an increased dose of ICS+LABA

"Exacerbations are a common worry for those living with asthma. Their sudden onset can be alarming to patients and their caregivers, which is why we aim to prevent them with treatment," said Bradley Chipps, MD, Medical Director of Respiratory Therapy and the Cystic Fibrosis Center at the Sutter Medical Center in Sacramento, California, who served as an investigator and co-author of the study. "Instead of increasing the dose of the ICS+LABA, healthcare providers should consider Spiriva Respimat as a treatment option that may lower the risk and occurrence of asthma exacerbations."

Approximately 25 million people in the U.S. are living with asthma, and in more than 60% of adults, the condition is uncontrolled. Uncontrolled asthma can impair lung function, increase risk of exacerbations, reduce quality of life, and is associated with higher health care resource utilization (HCRU) and costs.^2,3,4

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ⁱ Results from real-world studies are not intended for comparisons with clinical trials. Real-world studies were observational trials. Difference in study designs, patient populations, outcomes definitions, and methods of collecting data make it difficult to make comparisons with clinical trials or with each other. Real-world data should be viewed as complementary information.

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. 

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.

About Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., 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 our goal is to improve the lives of humans and animals through its three business areas: human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

Boehringer Ingelheim concentrates on developing innovative therapies that can improve and extend patients' lives. As a research-driven pharmaceutical company, it plans in generations for long-term success. Its research efforts are focused on diseases with high, unmet medical need. In animal health, the company stands for advanced prevention.

In 2018, Boehringer Ingelheim achieved net sales of around $20.7 billion (17.5 billion euros). R&D expenditure of almost $3.7 billion (3.2 billion euros) corresponded to 18.1 per cent of net sales. Boehringer Ingelheim is committed to improving lives and strengthening our communities.  Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives.

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

Media Contact:                   

Chris Wahlers
Boehringer Ingelheim Pharmaceuticals, Inc.
203-798-4375
[email protected]

References

1. Asthma attack. (2019, August 2). Retrieved from https://www.mayoclinic.org/diseases-conditions/asthma-attack/symptoms-causes/syc-20354268.
2. Asthma Surveillance Data. (2019, March 25). Retrieved from https://www.cdc.gov/asthma/asthmadata.htm.
3. AsthmaStats: Uncontrolled Asthma among Adults, 2016. (2019, July 8). Retrieved from https://www.cdc.gov/asthma/asthma_stats/uncontrolled-asthma-adults.htm.
4. Data on file.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.