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Efficacy and Safety of 2 Doses of Tiotropium Respimat Compared to Placebo in Adolescents With Severe Persistent Asthma | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 mcg and 5 mcg Once Daily) Over 12 Weeks as add-on Controller Therapy on Top of Usual Care in Adolescents (12 to 17 Years Old) With Severe Persistent Asthma

NCT01277523•Boehringer Ingelheim

View on ClinicalTrials.gov

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) over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma. The primary objective of the trial is to demonstrate superiority of tiotropium (5 mcg and possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary pulmonary function endpoint after 12 weeks of treatment. Secondary objectives are to evaluate efficacy of tiotropium with regard to other endpoints, and to evaluate the safety of tiotropium, compared to placebo, as add-on controller therapy on top of usual care in this patient population.

Eligibility

Age

12 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. All patients and their parent(s) (or legally accepted representative) must sign and date respectively an informed assent and an informed consent consistent with International Conference on Harmonisation - Harmonised Tripartite Guideline for Good Clinical Practice (ICH-GCP) guidelines and local legislation prior to the patient's participation in the trial. A separate informed consent/assent is required for pharmacogenomic sampling.
•2. Male or female patients between 12 and 17 years of age (at date of informed consent/assent).
•3. All patients must have at least a 3-month history of asthma at the time of enrolment into the trial.
•4. All patients must have been on maintenance treatment with an inhaled corticosteroid either at stable high dose in combination with another controller medication, OR at stable medium dose in combination with two other controller medications, for at least 4 weeks before Visit 1.
•5. All patients must be symptomatic at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ) mean score of = 1.5.
•6. All patients must have a pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) = 60% and = 90% of predicted normal at Visit 1.
•7. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator, considered as 100%) as compared to Visit 2 (pre-dose) must be within ± 30%.
•8. All patients must confirm the diagnosis of asthma by bronchodilator reversibility at Visit 1, resulting in an increase in FEV1 of = 12% and = 200 mL 15 to 30 minutes after 400 µg salbutamol (albuterol). If patients in the lower age range (e.g. 12 to 14 year old patients) exhibit a very small total lung volume, positive reversibility testing might be based solely on the relative (=12%) post-bronchodilator response.
•9. All patients must be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment.
•10. Patients must be able to use the Respimat® inhaler correctly.
+1 more criteria

Exclusion Criteria

•1. Significant disease other than asthma.
•2. Abnormal haematology or blood chemistry.
•3. History of heart disease, and/or hospitalised for cardiac syncope or failure.
•4. Any unstable or life-threatening or requiring intervention or cardiac arrhythmia.
•5. Malignancy for which the patient has undergone resection, radiation therapy or chemotherapy.
•6. Active tuberculosis.
•7. Alcohol or drug abuse.
•8. Thoracotomy with pulmonary resection.
•9. Pulmonary rehabilitation program.
•10. Hypersensitivity to anticholinergic drugs, or any components of the study medication delivery system.
+17 more criteria

Locations (69)

205.456.01004 Boehringer Ingelheim Investigational Site

Stockton, California, United States

205.456.01008 Boehringer Ingelheim Investigational Site

Normal, Illinois, United States

205.456.01003 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

205.456.01007 Boehringer Ingelheim Investigational Site

Columbia, Missouri, United States

205.456.01002 Boehringer Ingelheim Investigational Site

Bellevue, Nebraska, United States

205.456.01001 Boehringer Ingelheim Investigational Site

Rockville Centre, New York, United States

205.456.01005 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

205.456.01006 Boehringer Ingelheim Investigational Site

Summerville, South Carolina, United States

205.456.54002 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

205.456.54006 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Key Dates

Start Date

January 1, 2011

Primary Completion Date

October 1, 2013

Completion Date

October 1, 2013

Last Updated

October 20, 2014

Enrollment

392

ACTUAL participants

Conditions

Asthma

Interventions

tiotropium high dose

DRUG

placebo

DRUG

tiotropium low dose

DRUG

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NCT07219173

Asthma

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RECRUITINGNA

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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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: October 20, 2014Data 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

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

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

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