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A Study to Evaluate Efficacy and Safety of Tiotropium in Children 6 to 11 Years Old With Moderate Asthma

NCT01383499 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2015-04-15

Study results available
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Summary

The aim of this trial is to select an optimum dose may be selected based on bronchodilator efficacy, safety evaluations and pharmacokinetics of tiotropium bromide.

Conditions

Interventions

DRUG

Tiotropium bromide

inhalation solution administered via Respimat in 3 different doses

DRUG

Tiotropium bromide

inhalation solution administered via Respimat in 3 different doses

DRUG

Tiotropium bromide

inhalation solution administered via Respimat in 3 different doses

DRUG

Tiotropium bromide

inhalation solution administered via Respimat in 3 different doses

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Germany
  • Hungary
  • Latvia
  • Lithuania
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

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 NCT01383499 on ClinicalTrials.gov