drugset / Trial / NCT00168844
Tiotropium / Respimat One-Year Study
RandomizedParallel-groupDouble-blindTreatment
Summary
To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.
Timeline
- Start
- 2003-01
- Primary completion
- 2005-06
- Completion
- —
Outcome
Met primary endpoint
registry Tiotropium Respimat 5mcg vs Placebo; p <0.0001; Mean Difference (Final Values) 0.142; ANCOVA NCT00168844 ↗
registry Tiotropium Respimat 5mcg vs Placebo; p = 0.0011; Mean Difference (Final Values) -3.269; ANCOVA NCT00168844 ↗
registry Tiotropium Respimat 5mcg vs Placebo; p <0.0001; Mean Difference (Final Values) 1.053; ANCOVA NCT00168844 ↗
registry Tiotropium Respimat 5mcg vs Placebo; p = 0.0002; Odds Ratio (OR) 0.782 (95% CI 0.687 to 0.890); Poisson regression NCT00168844 ↗
Publications
- Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.
- 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.
- Hodder R, Pavia D, Lee A, Bateman E. Lack of paradoxical bronchoconstriction after administration of tiotropium via Respimat(R) Soft Mist Inhaler in COPD. Int J Chron Obstruct Pulmon Dis. 2011;6:245-51. doi: 10.2147/COPD.S16094. Epub 2011 Apr 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tiotropium | Other / unclassified | 5 ug | Inhaled |
| Subject | Tiotropium | Other / unclassified | 10 ug | Inhaled |