The AIRWISE phase 4 clinical trial aiming to assess how commonly prescribed medicines may decrease the worsening of symptoms in chronic obstructive pulmonary disease (COPD) has begun enrolling the first patients.
The AIRWISE trial (NCT03265145) is described as the world’s largest ever pragmatic clinical trial, meaning it is designed to test a medication’s effectiveness in routine clinical practice settings.
The trial will provide information on the ability of inhaled corticosteroids (ICS) to reduce COPD exacerbations, or flare-ups, when used in combination with common COPD therapies long-acting muscarinic antagonists (LAMA) and long-acting ß-agonists (LABA). Results from the study are expected 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,” Mark Napier, MD, medical director at Anthem, who was involved in the trial’s design, said in a press release.
“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.” Napier added.
The study will compare Boehringer Ingelheim’s Stiolto Respimat (tiotropium bromide and olodaterol) inhalation spray with any commercially available triple combination of a LAMA, a LABA and an ICS in a real-world setting.
The 52-week study will include 3,200 adults with COPD whose disease is not under control with either a LAMA, a LABA or an ICS/LABA. The study is currently enrolling participants. Visit the trial website for contact information and locations.
The scientists will primarily focus on the time to the first moderate or severe COPD exacerbation. The annual rate of COPD exacerbations, and the total COPD-related healthcare utilization (inpatient admissions, emergency room visits, outpatient encounters and office visits) will also be addressed.
“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, MD, vice president of Clinical Development and Medical Affairs – Primary Care at Boehringer Ingelheim.
“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,” Seck added.
AIRWISE is part of the multi-year research collaboration established in 2014 by Anthem and Boehringer Ingelheim. The companies partnered to address unmet medical needs and explore the appropriate use of current and new therapies and interventions, determining their impact on clinical and economic outcomes.
Approximately 15 million Americans are estimated to suffer from COPD. A COPD exacerbation is a sudden deterioration of symptoms, including aggravated breathlessness, cough, mucus production and extreme fatigue. These occurrences can result in quicker disease progression and in permanent reductions in lung function, hospitalization, or even death. COPD exacerbations also increase the financial burden on the healthcare system, making their prevention crucial.
“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.” said Vincent Willey, PharmD, staff vice president at HealthCore.