Ambitions of the World’s Largest Pragmatic Clinical Trial in COPD

Pragmatic clinical trials (PCTs) promise to address much of healthcare’s urgent need for real-world evidence to inform and improve decision-making in patient care and health policy.

PCTs evaluate health technologies as they are used in actual medical practice, evaluating not only therapeutic benefits and risks in real-world populations, but also measuring economic impact, and elucidating other important contributing factors such as prescribing practices and patient compliance.

HealthCore is collaborating with Anthem, Inc. and Boehringer Ingelheim to conduct AIRWISE – the world’s largest ever pragmatic clinical trial in chronic obstructive pulmonary disease (COPD).  This landmark research will allow us to see how long-acting muscarinic antagonists (LAMA), long-acting ß-agonists (LABA) and inhaled corticosteroids (ICS) work 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.

The AIRWISE trial will compare the effectiveness of Stiolto Respimat 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.

By enrolling affiliated health plan members, Anthem – one of the largest health plans in the U.S. healthcare system – will enable its participating members the opportunity to support medical innovation and cutting edge research.

HealthCore’s access to, and nuanced understanding of, the Anthem health plan and related claims data coupled with the breadth, depth and diversity of this trial population is expected to yield evidence more robust than is generated in traditional randomized controlled trials and more generalizable to COPD patients in the real world.  The results will provide healthcare decision makers the level of evidence necessary to make optimal decisions, with the aim of providing better outcomes, improved overall patient health and lower costs for patients and the healthcare system.

HealthCore is thrilled and proud to be part of this landmark study that will help to evolve our understanding of COPD and its treatment.  Through this study, Anthem and HealthCore hope to deliver high-level actionable evidence that can be used to help provide high quality evidence for stakeholders, and high quality, affordable care for Anthem members.