Pneumologie 2015; 69 - P127
DOI: 10.1055/s-0035-1544635

Tiotropium Respimat: Comparison of bronchodilator efficacy of 5 and 2.5 µg doses

J Hohlfeld 1, P Calverley 2, M Könen-Bergmann 3, N Metzdorf 3, S Bell 4
  • 1Clinical Airway Research, Fraunhofer Institute of Toxicology and Experimental Medicine (ITEM)
  • 2Respiratory Medicine, Institute of Ageing and Chronic Disease, University of Liverpool
  • 3Clinical Development + Medical Affairs, Boehringer Ingelheim Pharma GmbH & Co KG
  • 4Statistics, Boehringer Ingelheim Pharma GmbH & Co KG

Background: Safety and efficacy of tiotropium Respimat 5 µg (R5) and 2.5 µg (R2.5) doses were compared with tiotropium HandiHaler 18 µg (HH) in two recent chronic obstructive pulmonary disease (COPD) trials.

Aims and objectives: To compare bronchodilator efficacy of once-daily R5 and R2.5 and HH in TIOtropium Safety and Performance In Respimat (TIOSPIR; NCT01126437)1 and the 205.458 (NCT01222533)2 trials.

Methods: TIOSPIR: Randomized, double-blind (n= 17,135; mean 2.3 years' follow up) trial assessing mortality and exacerbations. Included a spirometry substudy (n= 1370), predefined test of noninferiority of R5 and R2.5 vs HH for trough forced expiratory volume in 1 second (FEV1), average 24 – 120 weeks (noninferiority margin 50 mL).

205.458: Multicentre, placebo-controlled, randomized within Respimat (1.25, 2.5, 5 µg), five-way crossover trial with 4-week treatment periods (n= 154).

Results: TIOSPIR: Adjusted mean trough FEV1 (average 24 – 120 weeks) was 1.285L for R5 and 1.295 L for HH (difference vs HH, -10 mL; 95% confidence interval [CI], -38 to 18 mL), and 1.258 L for R2.5 (difference vs HH, -37 mL; 95% CI, -65 to -9 mL).

205.458: R2.5, R5 and HH showed significant improvements in trough FEV1 versus placebo. Mean trough FEV1 for R5 was comparable to HH but was 27 and 41 mL lower than HH for R2.5 and R1.25, respectively.

Conclusion: In TIOSPIR, R5 was noninferior to HH for FEV1, but R2.5 was inferior to HH. Similar results were seen in the 205.458 trial and support the use of tiotropium Respimat 5µg once daily for the maintenance treatment of COPD.

Presented at ERS congress 2014