Anthem, HealthCore, Boehringer initiate pragmatic clinical trial to study people living with COPD in 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.

“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.

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.