Real-World COPD Trial Examines Triple-Combination Therapies

The world’s largest pragmatic clinical trial on chronic obstructive pulmonary disease (COPD), AIRWISE, is being undertaken by a trio of health care companies - Anthem, its subsidiary HealthCore, and Boehringer Ingelheim - to study patients in a real-world setting.

With a goal of studying which commonly prescribed therapies can reduce exacerbations in patients with COPD, a consequence of the condition that has long plagued these patients.

“The AIRWISE trial is designed to test 2 commonly used interventions in the full spectrum of everyday clinical settings in order to maximize applicability and generalizability,” Thomas Seck (pictured), MD, the vice president of clinical development, medical affairs, and primary care at Boehringer Ingelheim, told MD Magazine. “The goal of this research is to compare their effectiveness and to inform clinical decision making by pulmonologists and primary care physicians to ensure patients receive the right treatment regimen based on their individual clinical circumstances.”

AIRWISE will examine the role that long-acting muscarinic antagonists (LAMA), long-acting ß-agonists (LABA), and inhaled corticosteroids (ICS) play in reducing exacerbation risk in patients with COPD. In September 2017, the US Food and Drug Administration approved the first once-daily triple therapy for COPD, Trelegy Ellipta (GSK), which combines LAMA, LABA, and ICS.

The AIRWISE study results will help clinicians’ understanding of how LABA/LAMA and combination triple therapies can reduce the risk of COPD exacerbations and improve patient outcomes, according to Seck. Results will be available in 2020.

“Many healthcare providers currently use ICS -based treatment regimens as a routine part of COPD treatment, independent from patients’ severity of their disease,” Seck said. “However, emerging clinical evidence suggests that only a small proportion of COPD patients actually receive additional clinical benefit from the use of an ICS. Guidelines from the Global Initiative for Chronic Obstructive Lung Disease (GOLD) suggest reserving ICS for the most severe disease, yet COPD maintenance treatment is initiated with ICS combinations more than 50% of the time.”

The trial is set to compare combination inhalation spray tiotropium bromide and olodaterol (Stiolto Respimat) and any commercially available triple combination LAMA/LABA/ICS in a real-world setting. It will take place over 52 weeks, enrolling 3200 adults with COPD.

“Exacerbations of COPD are serious and can lead to accelerated and permanent reductions in lung function, hospitalization or even death,” Seck said. “These potential consequences of COPD exacerbations make their prevention very important.”

COPD exacerbations can also have an impact on the use of health care resources, according to Seck, as they impact hospital admissions, emergency room visits and outpatient visits, and could possibly be considered to be a factor in the increase of the burden on the healthcare system as a whole.