Tiotropium respimat

TIOSPIR^® was an event-driven, randomized, double-blind, parallel-group trial of 17,135 patients with COPD. We recruited patients aged ≥40 years with a clinical diagnosis of COPD, ≥10 pack years of smoking history, a post-bronchodilator FEV₁/forced vital capacity (FVC) ratio ≤0.70, and an FEV₁ ≤70% predicted. Patients with concomitant cardiac disease were included except for those with unstable (requiring new treatment within last 12 months) or recent events (within last 6 months). Patients with other clinically significant lung diseases or a COPD exacerbation within the past month, moderate or severe renal impairment, or those with cancer requiring therapy within the past 5 years were excluded. All COPD medications, except other inhaled anticholinergics, were allowed. Patients were randomized to once-daily 2.5 μg of tiotropium Respimat^® (Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany), 5 μg of tiotropium Respimat^®, or 18 μg of tiotropium HandiHaler^®. (Boehringer Ingelheim Pharma GmbH & Co. KG)

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.