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Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Severe Persistent Asthma

NCT01634152 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 401

Last updated 2016-01-29

Study results available
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Summary

The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children (6 to 11 years old) with severe persistent asthma.

Conditions

Interventions

DRUG

Placebo

2 actuations once daily in the evening

DRUG

Tiotropium low dose mcg

2 actuations once daily in the evening

DRUG

Tiotropium high dose

2 actuations once daily in the evening

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Germany
  • Guatemala
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Russia
  • Slovakia
  • Ukraine

Study Locations

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 NCT01634152 on ClinicalTrials.gov