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

NCT01634139 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 403

Last updated 2016-07-12

Study results available
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Summary

The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily in the evening) over 48 weeks, compared to placebo, in children (6 to 11 years old) with moderate persistent asthma.

Conditions

Interventions

DRUG

Tiotropium low dose QD

2 actuations once daily in the evening

DRUG

Tiotropium high dose QD

2 actuations once daily in the evening

DRUG

Placebo

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
2015-06-30
Completion
2015-12-31

Countries

  • United States
  • Bulgaria
  • Canada
  • Germany
  • Guatemala
  • Hungary
  • Latvia
  • Lithuania
  • Norway
  • Portugal
  • Romania
  • Russia
  • South Korea
  • Sweden
  • Ukraine
  • United Kingdom

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 NCT01634139 on ClinicalTrials.gov