Tiotropium Respimat Pharmacokinetic Study in COPD
Summary
The purpose of this study is compare the effect of different doses of tiotropium delivered by the HandiHaler and Respimat device on lung function. Additionally, the study will investigate the pharmacokinetic profile of these different doses. Studying the pharmacokinetic profile shows what happens to the medication in the body over a period of hours and provides information on potential effects of the medication.
Timeline
- Start
- 2010-10
- Primary completion
- 2011-11
- Completion
- —
Outcome
Missed primary endpoint
registry analysis (non-inferiority or equivalence test); Tio R5 vs Tio HH18; p = 0.4423; Geometric mean ratio (percentage) 80.66 (90% CI 73.49 to 88.52) NCT01222533 ↗
registry analysis (non-inferiority or equivalence test); Tio R5 vs Tio HH18; p = 0.8683; Geometric mean ratio (percentage) 75.99 (90% CI 70.44 to 81.98) NCT01222533 ↗
Publications
- Hohlfeld JM, Furtwaengler A, Konen-Bergmann M, Wallenstein G, Walter B, Bateman ED. Cardiac safety of tiotropium in patients with COPD: a combined analysis of Holter-ECG data from four randomised clinical trials. Int J Clin Pract. 2015 Jan;69(1):72-80. doi: 10.1111/ijcp.12596. Epub 2014 Dec 11.
- Hohlfeld JM, Sharma A, van Noord JA, Cornelissen PJ, Derom E, Towse L, Peterkin V, Disse B. Pharmacokinetics and pharmacodynamics of tiotropium solution and tiotropium powder in chronic obstructive pulmonary disease. J Clin Pharmacol. 2014 Apr;54(4):405-14. doi: 10.1002/jcph.215. Epub 2013 Nov 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tiotropium | Other / unclassified | 1.25 ug | Inhaled |
| Subject | Tiotropium | Other / unclassified | 2.5 ug | Inhaled |
| Subject | Tiotropium | Other / unclassified | 5 ug | Inhaled |
| Subject | Tiotropium | Other / unclassified | 18 ug | Inhaled |