TIOSPIR®: Large scale trial of tiotropium Respimat® vs HandiHaler® (HH) in patients (pts) with COPD

Background: Direct comparisons of tiotropium Respimat® and HH in pts with COPD are limited. Prospective long-term data are needed to assess the relative effects on efficacy and safety. Aims and objectives: Compare safety and efficacy (exacerbations) of 5 µg and 2.5 µg once daily tiotropium Respimat® with 18 µg tiotropium HH in a phase IIIb study (TIOSPIR ® ). Methods: Randomized, active-controlled, double-blind, double-dummy, parallel-group, non-inferiority, event-driven, international multicentre (50 countries) trial of pts aged ≥40 y with COPD (postbronchodilator (postBD) FEV1 ≤70% pred., FEV1/FVC ≤70%), smoking history ≥10 pack-y. Primary endpoints: time to death (all-cause; non-inferiority analysis), time to first exacerbation (superiority analysis). Secondary endpoints: no. of: exacerbations, hospitalized exacerbations; time to: first hospitalized exacerbation, major cardiovascular AE. Time-to-event analyzed using Cox proportional hazards; no. of events: negative binomial model. Results: Enrollment completed in April 2011; 17135 pts began treatment (Table). View this table: Conclusion: TIOSPIR® will provide robust data on relative safety and efficacy of tiotropium Respimat® vs HH from moderate to very severe COPD and across comorbidities. Funded by Boehringer Ingelheim.