Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease

Summary

Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.

Timeline

Start

2010-05

Primary completion

2013-05

Completion

2013-05

Publications

• Wise RA, Calverley PM, Carter K, Clerisme-Beaty E, Metzdorf N, Anzueto A. Seasonal variations in exacerbations and deaths in patients with COPD during the TIOSPIR(R) trial. Int J Chron Obstruct Pulmon Dis. 2018 Feb 14;13:605-616. doi: 10.2147/COPD.S148393. eCollection 2018.
• Calverley PMA, Mueller A, Fowler A, Metzdorf N, Wise RA. The Effect of Defining Chronic Obstructive Pulmonary Disease by the Lower Limit of Normal of FEV1/FVC Ratio in Tiotropium Safety and Performance in Respimat Participants. Ann Am Thorac Soc. 2018 Feb;15(2):200-208. doi: 10.1513/AnnalsATS.201703-194OC.
• Dahl R, Calverley PM, Anzueto A, Metzdorf N, Fowler A, Mueller A, Wise R, Dusser D. Safety and efficacy of tiotropium in patients switching from HandiHaler to Respimat in the TIOSPIR trial. BMJ Open. 2015 Dec 29;5(12):e009015. doi: 10.1136/bmjopen-2015-009015.
• Anzueto A, Wise R, Calverley P, Dusser D, Tang W, Metzdorf N, Dahl R. The Tiotropium Safety and Performance in Respimat(R) (TIOSPIR(R)) Trial: Spirometry Outcomes. Respir Res. 2015 Sep 15;16(1):107. doi: 10.1186/s12931-015-0269-4.
• Wise RA, Anzueto A, Cotton D, Dahl R, Devins T, Disse B, Dusser D, Joseph E, Kattenbeck S, Koenen-Bergmann M, Pledger G, Calverley P; TIOSPIR Investigators. Tiotropium Respimat inhaler and the risk of death in COPD. N Engl J Med. 2013 Oct 17;369(16):1491-501. doi: 10.1056/NEJMoa1303342. Epub 2013 Aug 30.

Drugs

Indications