drugset / Trial / NCT02172534

Safety, Tolerability and Pharmacokinetics of Tiotropium in Cystic Fibrosis Patients

NCT02172534

Phase 1 Completed 113 enrolled Boehringer Ingelheim
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

EvaluationDrugModalityDoseRoute
Subject Tiotropium Other / unclassified 2.5 ug Inhaled
Subject Tiotropium Other / unclassified 5 ug Inhaled
Subject Tiotropium Other / unclassified 10 ug Inhaled

Indications