drugset / Trial / NCT02172534
Safety, Tolerability and Pharmacokinetics of Tiotropium in Cystic Fibrosis Patients
RandomizedParallel-groupDouble-blindTreatment
Summary
Study to obtain information about the safety and tolerability of tiotropium bromide administered via the Respimat® inhalation device in pediatric (≤11 y.o.) and adolescent/adult (≥12 y.o.) cystic fibrosis (CF) patients after single and multiple doses as well as to obtain pharmacokinetic data for tiotropium in CF patients after single and multiple doses
Timeline
- Start
- 2006-09
- Primary completion
- 2008-09
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tiotropium | Other / unclassified | 2.5 ug | Inhaled |
| Subject | Tiotropium | Other / unclassified | 5 ug | Inhaled |
| Subject | Tiotropium | Other / unclassified | 10 ug | Inhaled |