MedTrace Logo

Safety, Tolerability and Pharmacokinetics of Tiotropium in Cystic Fibrosis Patients

NCT02172534 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2014-06-24

No results posted yet for this study

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

Conditions

Interventions

DRUG

Tiotropium bromide low

DRUG

Tiotropium bromide medium

DRUG

Tiotropium bromide high

DRUG

Placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2008-09-30

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02172534 on ClinicalTrials.gov