Boehringer Ingelheim, insurer Anthem, and Anthem’s research subsidiary HealthCore have announced the initiation of the AIRWISE study, which will compare Stiolto Respimat tiotropium bromide/olodaterol SMI to any commercially available combination of LAMA, LABA, and ICS for the reduction of COPD exacerbations in a real world setting. Results are expected in 2020.
The FDA approved Stiolto Respimat for the treatment of COPD in May 2015, and BI launched the SMI in the US the next month.
The year-long randomized open-label trial is expected to enroll 3,200 COPD patients in the US, and the primary endpoint will be time to first moderate-to-severe exacerbation.
Anthem Medical Director Mark Napier said, “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. 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.”
Boehringer Ingelheim Pharmaceuticals VP of Clinical Development and Medical Affairs, Primary Care, Thomas Seck commented, “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. 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 overtreated with drugs that may provide no additional benefit and may have additional side effects.”
Read the Boehringer Ingelheim and Anthem press release.
