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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01634139

Public ClinicalTrials.gov record NCT01634139. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 1:44 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial 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 48 Weeks in Children (6 to 11 Years Old) With Moderate Persistent Asthma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01634139
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
403 participants

Conditions and interventions

Eligibility (public fields only)

Age range
6 Years to 11 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2012
Primary completion
May 31, 2015
Completion
Nov 30, 2015
Last update posted
Jul 11, 2016

2012 – 2015

United States locations

U.S. sites
6
U.S. states
5
U.S. cities
6
Facility City State ZIP Site status
205.445.01002 Boehringer Ingelheim Investigational Site Columbia Missouri
205.445.01001 Boehringer Ingelheim Investigational Site Cincinnati Ohio
205.445.01010 Boehringer Ingelheim Investigational Site Oklahoma City Oklahoma
205.445.01006 Boehringer Ingelheim Investigational Site Charleston South Carolina
205.445.01012 Boehringer Ingelheim Investigational Site Arlington Texas
205.445.01004 Boehringer Ingelheim Investigational Site El Paso Texas

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 73 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01634139, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 11, 2016 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01634139 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →