In TIOSPIR, 17,135 patients with COPD were randomized and treated in a double-blind, parallel-group, event-driven trial with follow-up of 2–3 years. Patients were randomized to once-daily tiotropium Respimat 5 or 2.5 μg, or once-daily tiotropium HandiHaler 18 μg (both Boehringer Ingelheim, Ingelheim am Rhein, Germany). The trial design and methodology have been published previously.13 (link) TIOSPIR was performed in accordance with the provisions of the Declaration of Helsinki, and the study protocol and procedures were approved by relevant institutional review boards and ethics committees (independent ethics committee Johns Hopkins Medicine Institutional Review Board, Baltimore, MD, USA). All the patients provided written informed consent.