Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Moderate Persistent Asthma
Summary
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily in the evening) over 48 weeks, compared to placebo, in children (6 to 11 years old) with moderate persistent asthma.
Timeline
- Start
- 2012-07
- Primary completion
- 2015-06
- Completion
- 2015-12
Outcome
Met primary endpoint
registry analysis (superiority or other test); Placebo Respimat vs Tio R2.5; p <0.0001; Mean Difference (Net) 0.170 (95% CI 0.108 to 0.231); Mixed Models Analysis NCT01634139 ↗
registry analysis (superiority or other test); Placebo Respimat vs Tio R5; p <0.0001; Mean Difference (Net) 0.164 (95% CI 0.103 to 0.255); Mixed Models Analysis NCT01634139 ↗
release “Phase III CanoTinA-asthma trial that showed adding tiotropium RESPIMAT to maintenance asthma therapy, in children aged 6-11, significantly improved lung function” prnewswire.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tiotropium | Other / unclassified | 2.5 ug | Inhaled |
| Subject | Tiotropium | Other / unclassified | 5 ug | Inhaled |