Boehringer, Anthem begin real-world COPD trial
Boehringer Ingelheim GmbH (Ingelheim, Germany) and Anthem Inc. (NYSE:ANTM) and its outcomes research subsidiary HealthCore Inc. have begun enrolling patients in a real-world study evaluating the effect of Stiolto Respimat tiotropium/olodaterol on the occurrence of exacerbations in patients with chronic obstructive pulmonary disease. The partners said their Phase IV study will be the "world’s largest ever pragmatic clinical trial" in COPD.
The 52-week, randomized, open-label AIRWISE trial will compare the effectiveness of Stiolto -- a once-daily fixed-dose combination of olodaterol, a long-acting beta 2 agonist (LABA), and Spiriva tiotropium, a long-acting muscarinic antagonist (LAMA) -- with triple combinations that include a LABA, a LAMA and inhaled corticosteroids (ICS). The partners plan to enroll 3,200 adults whose COPD is not controlled by a LAMA, a LABA, or an ICS/LABA. Results are due in 2020...