Anthem, HealthCore and Boehringer Ingelheim Initiate World’s Largest Pragmatic Clinical Trial to Study People Living with COPD in a Real-World Setting

This landmark research is a collaboration between Anthem, Inc. , its outcomes research subsidiary, HealthCore, Inc. and Boehringer Ingelheim, a pharmaceutical company with a long history of leadership in respiratory research worldwide.

The AIRWISE trial will further inform the scientific community’s understanding of the role of long-acting muscarinic antagonists (LAMA), long-acting ß-agonists (LABA) and inhaled corticosteroids (ICS) in reducing the risk of COPD exacerbations. Whether or not an ICS provides a meaningful benefit in reducing COPD exacerbations, in addition to a LAMA and a LABA, is currently a topic of scientific debate. Results from the trial will be available in 2020.

“We’re pleased to offer our affiliated health plan members and their healthcare providers the opportunity to participate in this pioneering trial that is designed to answer an important scientific question,” said Dr. Mark Napier , medical director for Anthem, Inc. , who participated in the trial’s design. “As a pulmonologist, I am particularly interested in how AIRWISE will provide real-world data on a broad population of COPD patients that cannot be obtained from traditional randomized clinical trials. This will be invaluable for clinicians and health care organizations alike. Anthem’s national size and depth help to broaden the reach of the trial and will make the evidence more robust.”

A COPD exacerbation, or a flare-up, is a sudden worsening of symptoms, such as increased breathlessness, cough, mucus production and extreme fatigue. Exacerbations are serious and can lead to permanent reductions in lung function, hospitalization or even death. Exacerbations can often cause COPD to progress more quickly making their prevention very important. In addition to the detrimental effects on patients’ health, COPD exacerbations increase the burden on the healthcare system as a whole.

The AIRWISE trial will compare the effectiveness of STIOLTO® RESPIMAT® (tiotropium bromide & olodaterol) Inhalation Spray, the fixed-combination of tiotropium (a LAMA) and olodaterol (a LABA), with any commercially available triple combination of a LAMA, a LABA and an ICS in a real-world setting. The 52-week, randomized, open-label trial will enroll 3,200 adults with COPD whose healthcare provider has assessed that they are not controlled with their current therapy of a LAMA, a LABA or an ICS/LABA.

The primary endpoint of AIRWISE is the time to first moderate or severe COPD exacerbation. Other measurements include comparing the annual rate of moderate or severe COPD exacerbations and comparing all-cause and COPD-related healthcare resource utilization, including inpatient admissions, emergency room visits, outpatient encounters and office visits. For more information, please visit ClinicalTrials.gov (NCT03265145).

“Due to the significant impact of exacerbations on the health of people with COPD, it is critical that their occurrence is reduced with the safest and most effective treatment plans,” said Thomas Seck, M.D., vice president, Clinical Development and Medical Affairs, Primary Care, Boehringer Ingelheim Pharmaceuticals, Inc. “Our partnership with Anthem and HealthCore is an important initiative to help healthcare providers understand how two treatment approaches work in the real-world to reduce the occurrence of exacerbations. It is essential that patients are prescribed appropriate treatments and that they are not over-treated with drugs that may provide no additional benefit and may have additional side-effects.”

“We are thrilled and proud to be part of this landmark study that will help to evolve our understanding of COPD and its treatment,” said Vince Willey , PharmD, HealthCore staff vice president. “Moving forward, we hope that AIRWISE becomes a trailblazer for further pragmatic trials that inform patients, doctors, caregivers, life science companies and those who make health policy decisions. We believe it is important that everyday health decisions are based not only on data from traditional clinical trials, but also on data from real-world settings.”

In 2014, Anthem and Boehringer Ingelheim announced the beginning of a multi-year research collaboration to identify and address unmet medical needs across populations of mutual interest. Together, the companies are seeking to better serve patients and healthcare providers by exploring issues related to appropriate use of existing and new therapies and interventions, and the impact these have on clinical and economic outcomes.

About COPD

Chronic obstructive pulmonary disease is a term that includes chronic bronchitis and/or emphysema. This disease can make breathing harder because less air is able to flow in and out of the lungs. Chronic lower respiratory diseases, which include COPD, are the third leading cause of death in the United States , and approximately 15 million Americans have been told by a healthcare provider that they have COPD.

The most common symptom of COPD is shortness of breath, especially with physical activities. Coughing, with or without mucus production, is also a common symptom of COPD. These symptoms can be misunderstood as signs of aging. COPD is usually associated with progressive airway damage and loss that cause breathing to get more difficult.

INDICATION for STIOLTO RESPIMAT

STIOLTO RESPIMAT (tiotropium bromide and olodaterol) Inhalation Spray is a prescription medicine used long term, two puffs once each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.

STIOLTO contains the anticholinergic, tiotropium and the long-acting beta₂-adrenergic agonist (LABA), olodaterol. STIOLTO works by helping the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness and shortness of breath.

STIOLTO is not for treating sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.

Do not use STIOLTO if you have asthma. STIOLTO is approved to treat COPD only.

IMPORTANT SAFETY INFORMATION

People with asthma who take long-acting beta₂-agonist (LABA) medicines, such as olodaterol, (one of the medicines in STIOLTO), have an increased risk of death from asthma problems. It is not known if LABA medicines, such as olodaterol (one of the medicines in STIOLTO), increase the risk of death in people with COPD. STIOLTO has been approved for chronic obstructive pulmonary disease (COPD) only. STIOLTO is NOT to be used in asthma.

Do not use STIOLTO if you are allergic to tiotropium, ipratropium, atropine or similar drugs, olodaterol or any ingredient in STIOLTO. Symptoms of a serious allergic reaction may include rash, hives, swelling of the face, mouth, and tongue and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction. Do not use STIOLTO for treating sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.

Do not use STIOLTO more often or at higher doses than prescribed by your doctor. Do not use STIOLTO with other LABAs or anticholinergics. Get emergency medical care if your breathing problems worsen quickly or if you use your rescue inhaler but it does not relieve your breathing problems. Call your healthcare provider if breathing problems worsen over time while using STIOLTO.

Tell your doctor about all your medical conditions including heart problems, high blood pressure, seizures, thyroid problems, diabetes, kidney problems, glaucoma, enlarged prostate and problems passing urine.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines (including eye drops), vitamins and herbal supplements. STIOLTO may interact with other medicines which may cause serious side effects.

STIOLTO can cause serious side effects, including sudden shortness of breath that may be life threatening, fast or irregular heartbeat, increased blood pressure, chest pain, high blood sugar or low blood potassium that may cause muscle spasms or weakness or abnormal heart rhythm. If any of these happens, stop taking STIOLTO and seek immediate medical help.

STIOLTO can cause new or worsening eye problems including narrow-angle glaucoma, and can increase the pressure in your eyes, 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.

STIOLTO can cause new or worsened urinary retention. Symptoms of urinary retention may include difficulty passing urine, painful urination, urinating frequently or urinating in a weak stream or drips. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

STIOLTO is for oral inhalation only. The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler.

Do not spray STIOLTO into your eyes.

The most common side effects of STIOLTO are runny nose, cough and back pain.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

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.

Read the step-by-step patient Instructions for Use for STIOLTO RESPIMAT before you use your inhaler.

Please see accompanying Medication Guide, Instructions for Use and Full Prescribing Information, including boxed WARNING.

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.

About Anthem, Inc.

Anthem is working to transform health care with trusted and caring solutions. Our health plan companies deliver quality products and services that give their members access to the care they need. With over 74 million people served by its affiliated companies, including more than 40 million within its family of health plans, Anthem is one of the nation’s leading health benefits companies. For more information about Anthem’s family of companies, please visit www.antheminc.com/companies.

About HealthCore Inc.

HealthCore Inc. , www.healthcore.com, uses real world data, including claims information, to provide clinical and other scientific expertise and research services to the pharmaceutical, biotechnology and device industries, in the conduct of industry-sponsored safety, health economic outcomes, comparative effectiveness, epidemiological and late stage research projects. HealthCore’s capabilities include retrospective database design and analysis, prospective observational research design and analysis, safety and epidemiologic research services, post authorization safety study (PASS), health services research, patient and/or provider survey development and implementation and general research consultation.

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Source: Anthem, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc
Chris Wahlers
Email: christopher.wahlers@boehringer-ingelheim.com
Phone: 203-798-4375
or
Anthem, Inc.
Lori McLaughlin
Email: Lori.McLaughlin2@anthem.com
Phone: 317-407-7403