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Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo in 1 to 5 Year Old Patients With Persistent Asthma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo in 1 to 5 Year Old Patients With Persistent Asthma

A Phase II/III, Randomised, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate Safety and Efficacy of Tiotropium Inhalation Solution (2.5 µg and 5 µg) Administered Once Daily in the Afternoon Via Respimat® Inhaler for 12 Weeks in Patients 1 to 5 Years Old With Persistent Asthma

NCT01634113•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The primary objective of this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled corticosteroid (ICS) treatment.

Eligibility

Age

1 - 5 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. All patients' parents (or legal guardians) must sign and date an informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial. Where appropriate, participants should assent to enroll in the study.
•2. Male or female patients between 1 and 5 years of age.
•3. By a physician documented (at least 6 month) history of persistent asthma symptoms, including (but not limited to) wheezing, cough, and/or shortness of breath. (persistent = need for inhalation corticosteroid maintenance therapy to control asthma symptoms)
•4. For patients aged 5 years and capable of performing technically acceptable Pulmonary Function tests (PFTs): documented impaired lung function (i.e. pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is smaller or equal to 90% of predicted normal).
•5. All patients must have been on maintenance treatment with an inhaled corticosteroid at stable dose, either as mono treatment or in combination with another controller medication, for at least 4 weeks before Visit 1.
•6. All patients must be symptomatic (partly controlled) as defined by the Global Initiative for Asthma (GINA) guideline for children aged 5 years and younger in the week prior to Visit 1 (screening) and in the week prior to randomisation (Visit 2).

Exclusion Criteria

•1. Patients with a significant disease other than asthma.
•2. Patients with clinically relevant abnormal screening haematology or blood chemistry will be excluded if the abnormality defines a significant disease as defined in exclusion criterion 1.
•3. Patients with a history of congenital or acquired heart disease, or patients who have been hospitalised for cardiac syncope or failure during the past year.
•4. Patients with any unstable or life-threatening cardiac arrhythmia, including cardiac arrhythmia requiring intervention (e.g. pacemaker implantation) or a change in drug therapy within the past year.
•5. Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy.
•6. Patients with clinically significant lung diseases other than asthma.
•7. Alternative causes (other causes than asthma) that can lead to respiratory symptoms of wheeze, cough and shortness of breath.
•8. Patients with known active tuberculosis.
•9. Patients who have undergone thoracotomy with pulmonary resection.
•10. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1).

Locations (33)

205.443.12003 Boehringer Ingelheim Investigational Site

Columbia, Missouri, United States

205.443.12005 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

205.443.12006 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

205.443.12004 Boehringer Ingelheim Investigational Site

Summerville, South Carolina, United States

205.443.01004 Boehringer Ingelheim Investigational Site

Antwerp, Belgium

205.443.01002 Boehringer Ingelheim Investigational Site

Brussels, Belgium

205.443.01001 Boehringer Ingelheim Investigational Site

Edegem, Belgium

205.443.02002 Boehringer Ingelheim Investigational Site

Helsinki, Finland

205.443.02003 Boehringer Ingelheim Investigational Site

Turku, Finland

205.443.03003 Boehringer Ingelheim Investigational Site

Berlin, Germany

Key Dates

Start Date

July 1, 2012

Primary Completion Date

December 1, 2014

Completion Date

December 1, 2014

Last Updated

June 23, 2015

Enrollment

102

ACTUAL participants

Conditions

Asthma

Interventions

tiotropium-bromide

DRUG

tiotropium-bromide

DRUG

placebo

DRUG

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

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RECRUITING

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 23, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo in 1 to 5 Year Old Patients With Persistent Asthma

Inclusion Criteria

Exclusion Criteria

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

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