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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

Tiotropium low dose mcg

Tiotropium high dose

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Inclusion criteria are:

All patients' parent(s) (or legal guardian) must sign and date an informed consent prior to participation in the trial. In addition, an informed assent suitable for this age group has to be obtained from patients. A separate informed consent/assent is required for pharmacogenomic sampling.
Male or female patients between 6 and 11 years of age.
All patients must have at least a 6-month history of asthma.
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.
All patients must be symptomatic (partly controlled) at Visit 1 and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ-IA) mean score >= 1.5.
All patients must have a pre-bronchodilator forced expiratory volume in one second (FEV1) >= 60% and <= 90% of predicted normal at Visit 1.
Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator, considered as 100%) as compared to Visit 2 (pre-dose) must be within ± 30%.
All patients must confirm the diagnosis of asthma by bronchodilator reversibility at Visit 1, resulting in an increase in FEV1 of >= 12% 15 to 30 minutes after 200 mcg salbutamol/albuterol.
Patients must be able to use the Respimat inhaler correctly.
Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of electronic diary/peak flow meter (diary compliance of at least 80% is required).

Exclusion criteria:

Exclusion criteria are:

Patients with a significant disease other than asthma.
Patients with a clinically relevant abnormal haematology or blood chemistry at screening.
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.
Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
Patients with known active tuberculosis.
Patients who have undergone thoracotomy with pulmonary resection.
Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the six weeks prior to Visit 1.
Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the inhalation solution used with the Respimat inhaler.
Pregnant or nursing female patients, including postmenarchal girls with a positive urine pregnancy test at Visit 1.
Postmenarchal girls of child-bearing potential not using a highly effective method of birth control.
Patients who have been treated with systemic corticosteroids within four weeks prior to Visit 1.
Patients who have been treated with systemic beta-adrenergics within four weeks prior to Visit 1.
Patients who have been treated with oral beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period.
Patients who have been treated with inhaled long-acting anticholinergics or systemic anticholinergic treatment within four weeks prior to Visit 1 and/or during the screening period, or who have been treated with inhaled short-acting anticholinergics within two weeks prior to Visit 1.
Patients who have been treated with short-acting theophylline preparations within two weeks prior to Visit 1.
Patients who have been treated with non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1 and/or during the screening period.
Patients who have taken an investigational drug within six half lives according to the investigator's information, or four weeks (whichever is greater) prior to Visit 1 and/or during the screening period.
Patients who have previously been randomised in this trial or are currently participating in another trial.
Patients with any acute asthma exacerbation or respiratory tract infection in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2, the visit must be postponed.
Patients requiring six or more puffs of rescue medication per day on more than two consecutive days in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2, the visit must be postponed.
Patients who are unable to comply with medication restrictions prior to Visit 1 and/or prior to Visit 2.
Patients with a known narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated.
Patients with moderate to severe renal impairment, as defined by a creatinine clearance <50 mL/min/1.73 m2 BSA, as tiotropium is a predominantly renally excreted drug.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo QD

Tiotropium low dose QD

Tiotropium medium dose QD

Arm Description

Outcomes

Primary Outcome Measures

FEV1 Peak(0-3h) Change From Baseline

Change from baseline in peak forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak(0-3h)) measured at week 12. Measured values presented are actually adjusted means.

Secondary Outcome Measures

Trough FEV1 Change From Baseline

Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12. Measured values presented are actually adjusted means.

FVC Peak(0-3h) Change From Baseline

Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak(0-3h)) after 12 weeks of treatment. The measured values presented are actually adjusted means.

Trough FVC Change From Baseline

Change from baseline in Trough (pre-dose) FVC measured at week 12. Measured values presented are actually adjusted means.

FEV1 AUC (0-3h) Change From Baseline

Change from baseline of area under the curve (AUC) from 0 to 3 hours for FEV1 (FEV1 AUC (0-3h)) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h). Measured values presented are actually adjusted means.

FVC AUC (0-3h) Change From Baseline

Change from baseline of area under the curve (AUC) from 0 to 3 hours for FVC (Forced vital capacity) (FVC AUC (0-3h)) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h). Measured values presented are actually adjusted means.

FEV1 Change From Baseline at Each Individual Timepoint

Forced expiratory volume in one second (FEV1) change from baseline at each individual timepoint. The measured values presented are actually adjusted means.

FVC Change From Baseline at Each Individual Timepoint

FVC change from baseline at each individual timepoint. The measured values presented are actually adjusted means.

Control of Asthma as Assessed by ACQ-IA Total Score

Change from baseline in Interviewer-Administered Asthma Control Questionnaire (ACQ-IA) total score measured at week 12. The ACQ-IA is a scale containing 7 questions. Each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ-IA total score is calculated as the mean of the responses to all 7 questions. The measured values presented are actually adjusted means.

ACQ-IA Total Score Responders

Responder categories based on the ACQ-IA total score after 12 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5) No statistical testing was performed for ACQ-IA total score responders. The ACQ-IA is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment.

Use of PRN Rescue Medication Per Day

Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used per day (24 hour period) based on the weekly mean at week 12. The measured values presented are actually adjusted means.

Use of PRN Rescue Medication During the Daytime

Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 12. Measured values presented are actually adjusted means.

Use of PRN Rescue Medication During the Night-time

Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the night-time based on the weekly mean at week 12. Measured values presented are actually adjusted means

Peak Expiratory Flow (PEF) a.m. Change From Baseline

Change from baseline in the morning (a.m.) peak expiratory flow based on the weekly mean at week 12. Measured values presented are actually adjusted means.

Peak Expiratory Flow (PEF) p.m. Change From Baseline

Change from baseline in the evening (p.m.) peak expiratory flow based on the weekly mean at week 12. Measured values presented are actually adjusted means.

Peak Expiratory Flow (PEF) Variability Change From Baseline

Change from baseline in the peak expiratory flow variability based on the weekly mean at week 12. Measured values presented are actually adjusted means.

FEV1 a.m. Change From Baseline

Change from baseline in morning (a.m.) FEV1 based on the weekly mean at week 12. Measured values presented are actually adjusted means.

FEV1 p.m. Change From Baseline

Change from baseline in evening (p.m.) FEV1 based on the weekly mean at week 12. Measured values presented are actually adjusted means.

Change From Baseline in Nighttime Awakenings

Change from baseline in nighttime awakenings based on the weekly mean at week 12. Nighttime awakenings was assessed by the question "Did you wake up during the night due to your asthma?" from the e-diary. Scores range from 1 (did not wake up) to 5 (was awake all night). Measured values presented are actually adjusted means.

Change From Baseline in Morning Asthma Symptoms

Change from baseline in morning asthma symptoms based on the weekly mean at week 12. Morning asthma symptoms was assessed by the question "how were your asthma symptoms this morning?" from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms). Measured values presented are actually adjusted means.

Change From Baseline in Daytime Asthma Symptoms

Change from baseline in daytime asthma symptoms based on the weekly mean at week 12. Daytime asthma symptoms was assessed by the question "how were your asthma symptoms during the day?" from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms). Measured values presented are actually adjusted means.

Change From Baseline in Daytime Activity Limitations

Change from baseline in daytime activity limitations based on the weekly mean at week 12. Daytime activity limitations was assessed by the question "how limited were you in your activities today because of your asthma?" from the e-diary. Scores range from 1 (not limited) to 5 (totally limited). Measured values presented are actually adjusted means.

Change From Baseline in Daytime Experiences of Shortness of Breath

Change from baseline in daytime experiences of shortness of breath based on the weekly mean at week 12. Daytime experiences of shortness of breath was assessed by the question "how much shortness of breath did you experience during the day" from the e-diary. Scores range from 1 (none) to 5 (a very great deal). Measured values presented are actually adjusted means.

Change From Baseline in Daytime Experiences of Wheeze or Cough

Change from baseline in daytime experiences of wheeze or cough based on the weekly mean at week 12. Daytime experiences of wheeze or cough was assessed by the question "did you experience wheeze or cough during the day?" from the e-diary. Scores range from 1 (not at all) to 5 (all the time). Measured values presented are actually adjusted means.

Change From Baseline in Asthma Symptom-free Days

Change from baseline in asthma symptom-free days based on the weekly mean at week 12. A day was considered as an asthma symptom-free day if there were no symptoms reported via the e-Diary and no use of rescue medication reported via the eDiary during that day. Measured values presented are actually adjusted means.

Full Information

NCT ID

NCT01634152

First Posted

July 3, 2012

Last Updated

December 22, 2015

Sponsor

Boehringer Ingelheim

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01634152

Brief Title

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

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 12 Weeks as add-on Controller Therapy on Top of Usual Care in Children (6 to 11 Years Old) With Severe Persistent Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

Collaborators

Pfizer

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

401 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo QD

Arm Type

Placebo Comparator

Arm Title

Tiotropium low dose QD

Arm Type

Experimental

Arm Title

Tiotropium medium dose QD

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

2 actuations once daily in the evening

Intervention Type

Drug

Intervention Name(s)

Tiotropium low dose mcg

Intervention Description

2 actuations once daily in the evening

Intervention Type

Drug

Intervention Name(s)

Tiotropium high dose

Intervention Description

2 actuations once daily in the evening

Primary Outcome Measure Information:

Title

FEV1 Peak(0-3h) Change From Baseline

Description

Change from baseline in peak forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak(0-3h)) measured at week 12. Measured values presented are actually adjusted means.

Time Frame

Baseline and 12 weeks

Secondary Outcome Measure Information:

Title

Trough FEV1 Change From Baseline

Description

Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12. Measured values presented are actually adjusted means.

Time Frame

Baseline and 12 weeks

Title

FVC Peak(0-3h) Change From Baseline

Description

Time Frame

Baseline and 12 weeks

Title

Trough FVC Change From Baseline

Description

Change from baseline in Trough (pre-dose) FVC measured at week 12. Measured values presented are actually adjusted means.

Time Frame

Baseline and 12 weeks

Title

FEV1 AUC (0-3h) Change From Baseline

Description

Time Frame

Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks

Title

FVC AUC (0-3h) Change From Baseline

Description

Time Frame

Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks

Title

FEV1 Change From Baseline at Each Individual Timepoint

Description

Forced expiratory volume in one second (FEV1) change from baseline at each individual timepoint. The measured values presented are actually adjusted means.

Time Frame

Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks

Title

FVC Change From Baseline at Each Individual Timepoint

Description

FVC change from baseline at each individual timepoint. The measured values presented are actually adjusted means.

Time Frame

Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks

Title

Control of Asthma as Assessed by ACQ-IA Total Score

Description

Time Frame

Baseline and 12 weeks

Title

ACQ-IA Total Score Responders

Description

Time Frame

12 weeks

Title

Use of PRN Rescue Medication Per Day

Description

Time Frame

Baseline and 12 weeks

Title

Use of PRN Rescue Medication During the Daytime

Description

Time Frame

Baseline and 12 weeks

Title

Use of PRN Rescue Medication During the Night-time

Description

Time Frame

Baseline and 12 weeks

Title

Peak Expiratory Flow (PEF) a.m. Change From Baseline

Description

Change from baseline in the morning (a.m.) peak expiratory flow based on the weekly mean at week 12. Measured values presented are actually adjusted means.

Time Frame

Baseline and 12 weeks

Title

Peak Expiratory Flow (PEF) p.m. Change From Baseline

Description

Change from baseline in the evening (p.m.) peak expiratory flow based on the weekly mean at week 12. Measured values presented are actually adjusted means.

Time Frame

Baseline and 12 weeks

Title

Peak Expiratory Flow (PEF) Variability Change From Baseline

Description

Change from baseline in the peak expiratory flow variability based on the weekly mean at week 12. Measured values presented are actually adjusted means.

Time Frame

Baseline and 12 weeks

Title

FEV1 a.m. Change From Baseline

Description

Change from baseline in morning (a.m.) FEV1 based on the weekly mean at week 12. Measured values presented are actually adjusted means.

Time Frame

Baseline and 12 weeks

Title

FEV1 p.m. Change From Baseline

Description

Change from baseline in evening (p.m.) FEV1 based on the weekly mean at week 12. Measured values presented are actually adjusted means.

Time Frame

Baseline and 12 weeks

Title

Change From Baseline in Nighttime Awakenings

Description

Time Frame

Baseline and 12 weeks

Title

Change From Baseline in Morning Asthma Symptoms

Description

Time Frame

Baseline and 12 weeks

Title

Change From Baseline in Daytime Asthma Symptoms

Description

Time Frame

Baseline and 12 weeks

Title

Change From Baseline in Daytime Activity Limitations

Description

Time Frame

Baseline and 12 weeks

Title

Change From Baseline in Daytime Experiences of Shortness of Breath

Description

Time Frame

Baseline and 12 weeks

Title

Change From Baseline in Daytime Experiences of Wheeze or Cough

Description

Time Frame

Baseline and 12 weeks

Title

Change From Baseline in Asthma Symptom-free Days

Description

Time Frame

Baseline and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Inclusion criteria are: All patients' parent(s) (or legal guardian) must sign and date an informed consent prior to participation in the trial. In addition, an informed assent suitable for this age group has to be obtained from patients. A separate informed consent/assent is required for pharmacogenomic sampling. Male or female patients between 6 and 11 years of age. All patients must have at least a 6-month history of asthma. 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. All patients must be symptomatic (partly controlled) at Visit 1 and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ-IA) mean score >= 1.5. All patients must have a pre-bronchodilator forced expiratory volume in one second (FEV1) >= 60% and <= 90% of predicted normal at Visit 1. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator, considered as 100%) as compared to Visit 2 (pre-dose) must be within ± 30%. All patients must confirm the diagnosis of asthma by bronchodilator reversibility at Visit 1, resulting in an increase in FEV1 of >= 12% 15 to 30 minutes after 200 mcg salbutamol/albuterol. Patients must be able to use the Respimat inhaler correctly. Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of electronic diary/peak flow meter (diary compliance of at least 80% is required). Exclusion criteria: Exclusion criteria are: Patients with a significant disease other than asthma. Patients with a clinically relevant abnormal haematology or blood chemistry at screening. 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. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year. Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with known active tuberculosis. Patients who have undergone thoracotomy with pulmonary resection. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the six weeks prior to Visit 1. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the inhalation solution used with the Respimat inhaler. Pregnant or nursing female patients, including postmenarchal girls with a positive urine pregnancy test at Visit 1. Postmenarchal girls of child-bearing potential not using a highly effective method of birth control. Patients who have been treated with systemic corticosteroids within four weeks prior to Visit 1. Patients who have been treated with systemic beta-adrenergics within four weeks prior to Visit 1. Patients who have been treated with oral beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period. Patients who have been treated with inhaled long-acting anticholinergics or systemic anticholinergic treatment within four weeks prior to Visit 1 and/or during the screening period, or who have been treated with inhaled short-acting anticholinergics within two weeks prior to Visit 1. Patients who have been treated with short-acting theophylline preparations within two weeks prior to Visit 1. Patients who have been treated with non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1 and/or during the screening period. Patients who have taken an investigational drug within six half lives according to the investigator's information, or four weeks (whichever is greater) prior to Visit 1 and/or during the screening period. Patients who have previously been randomised in this trial or are currently participating in another trial. Patients with any acute asthma exacerbation or respiratory tract infection in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2, the visit must be postponed. Patients requiring six or more puffs of rescue medication per day on more than two consecutive days in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2, the visit must be postponed. Patients who are unable to comply with medication restrictions prior to Visit 1 and/or prior to Visit 2. Patients with a known narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated. Patients with moderate to severe renal impairment, as defined by a creatinine clearance <50 mL/min/1.73 m2 BSA, as tiotropium is a predominantly renally excreted drug.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

205.446.01014 Boehringer Ingelheim Investigational Site

City

Rolling Hills Estates

State/Province

California

Country

United States

Facility Name

205.446.01011 Boehringer Ingelheim Investigational Site

City

Denver

State/Province

Colorado

Country

United States

Facility Name

205.446.01003 Boehringer Ingelheim Investigational Site

City

North Dartmouth

State/Province

Massachusetts

Country

United States

Facility Name

205.446.01009 Boehringer Ingelheim Investigational Site

City

Columbia

State/Province

Missouri

Country

United States

Facility Name

205.446.01005 Boehringer Ingelheim Investigational Site

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

205.446.01010 Boehringer Ingelheim Investigational Site

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

205.446.01004 Boehringer Ingelheim Investigational Site

City

Charleston

State/Province

South Carolina

Country

United States

Facility Name

205.446.01002 Boehringer Ingelheim Investigational Site

City

North Charleston

State/Province

South Carolina

Country

United States

Facility Name

205.446.01012 Boehringer Ingelheim Investigational Site

City

Arlington

State/Province

Texas

Country

United States

Facility Name

205.446.01013 Boehringer Ingelheim Investigational Site

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

205.446.54006 Boehringer Ingelheim Investigational Site

City

Buenos Aires

Country

Argentina

Facility Name

205.446.54002 Boehringer Ingelheim Investigational Site

City

Capital Federal

Country

Argentina

Facility Name

205.446.54003 Boehringer Ingelheim Investigational Site

City

Capital Federal

Country

Argentina

Facility Name

205.446.54008 Boehringer Ingelheim Investigational Site

City

Capital Federal

Country

Argentina

Facility Name

205.446.54005 Boehringer Ingelheim Investigational Site

City

Mar del Plata

Country

Argentina

Facility Name

205.446.54004 Boehringer Ingelheim Investigational Site

City

Mendoza

Country

Argentina

Facility Name

205.446.54007 Boehringer Ingelheim Investigational Site

City

San Miguel de Tucuman

Country

Argentina

Facility Name

205.446.61003 Boehringer Ingelheim Investigational Site

City

Herston

State/Province

Queensland

Country

Australia

Facility Name

205.446.61001 Boehringer Ingelheim Investigational Site

City

Perth

State/Province

Western Australia

Country

Australia

Facility Name

205.446.32004 Boehringer Ingelheim Investigational Site

City

Antwerpen

Country

Belgium

Facility Name

205.446.32005 Boehringer Ingelheim Investigational Site

City

Brugge

Country

Belgium

Facility Name

205.446.32006 Boehringer Ingelheim Investigational Site

City

Namur

Country

Belgium

Facility Name

205.446.55001 Boehringer Ingelheim Investigational Site

City

Curitiba

Country

Brazil

Facility Name

205.446.55007 Boehringer Ingelheim Investigational Site

City

Goiânia

Country

Brazil

Facility Name

205.446.55006 Boehringer Ingelheim Investigational Site

City

Porto Alegre

Country

Brazil

Facility Name

205.446.55002 Boehringer Ingelheim Investigational Site

City

Sao Paulo

Country

Brazil

Facility Name

205.446.55003 Boehringer Ingelheim Investigational Site

City

Sao Paulo

Country

Brazil

Facility Name

205.446.55004 Boehringer Ingelheim Investigational Site

City

Sao Paulo

Country

Brazil

Facility Name

205.446.55005 Boehringer Ingelheim Investigational Site

City

Sao Paulo

Country

Brazil

Facility Name

205.446.02003 Boehringer Ingelheim Investigational Site

City

London

State/Province

Ontario

Country

Canada

Facility Name

205.446.02001 Boehringer Ingelheim Investigational Site

City

Sherbrooke

State/Province

Quebec

Country

Canada

Facility Name

205.446.42005 Boehringer Ingelheim Investigational Site

City

Jablonec nad Nisou

Country

Czech Republic

Facility Name

205.446.42001 Boehringer Ingelheim Investigational Site

City

Jihlava

Country

Czech Republic

Facility Name

205.446.42002 Boehringer Ingelheim Investigational Site

City

Prague

Country

Czech Republic

Facility Name

205.446.42004 Boehringer Ingelheim Investigational Site

City

Prague

Country

Czech Republic

Facility Name

205.446.49012 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

205.446.49015 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

205.446.49001 Boehringer Ingelheim Investigational Site

City

Bochum

Country

Germany

Facility Name

205.446.49007 Boehringer Ingelheim Investigational Site

City

Dresden

Country

Germany

Facility Name

205.446.49003 Boehringer Ingelheim Investigational Site

City

Frankfurt

Country

Germany

Facility Name

205.446.49009 Boehringer Ingelheim Investigational Site

City

Koblenz

Country

Germany

Facility Name

205.446.49014 Boehringer Ingelheim Investigational Site

City

Marburg

Country

Germany

Facility Name

205.446.49011 Boehringer Ingelheim Investigational Site

City

Mönchengladbach

Country

Germany

Facility Name

205.446.50201 Boehringer Ingelheim Investigational Site

City

Guatemala

Country

Guatemala

Facility Name

205.446.50202 Boehringer Ingelheim Investigational Site

City

Guatemala

Country

Guatemala

Facility Name

205.446.50203 Boehringer Ingelheim Investigational Site

City

Guatemala

Country

Guatemala

Facility Name

205.446.50204 Boehringer Ingelheim Investigational Site

City

Guatemala

Country

Guatemala

Facility Name

205.446.36002 Boehringer Ingelheim Investigational Site

City

Ajka

Country

Hungary

Facility Name

205.446.36001 Boehringer Ingelheim Investigational Site

City

Budapest

Country

Hungary

Facility Name

205.446.36003 Boehringer Ingelheim Investigational Site

City

Nagyatad

Country

Hungary

Facility Name

205.446.36004 Boehringer Ingelheim Investigational Site

City

Szeged

Country

Hungary

Facility Name

205.446.37105 Boehringer Ingelheim Investigational Site

City

Baldone

Country

Latvia

Facility Name

205.446.37104 Boehringer Ingelheim Investigational Site

City

Balvi

Country

Latvia

Facility Name

205.446.37108 Boehringer Ingelheim Investigational Site

City

Daugavpils

Country

Latvia

Facility Name

205.446.37107 Boehringer Ingelheim Investigational Site

City

Jekabpils

Country

Latvia

Facility Name

205.446.37101 Boehringer Ingelheim Investigational Site

City

Ogre

Country

Latvia

Facility Name

205.446.37106 Boehringer Ingelheim Investigational Site

City

Rezekne

Country

Latvia

Facility Name

205.446.37102 Boehringer Ingelheim Investigational Site

City

Riga

Country

Latvia

Facility Name

205.446.37103 Boehringer Ingelheim Investigational Site

City

Riga

Country

Latvia

Facility Name

205.446.37004 Boehringer Ingelheim Investigational Site

City

Siauliai

Country

Lithuania

Facility Name

205.446.37003 Boehringer Ingelheim Investigational Site

City

Taurage

Country

Lithuania

Facility Name

205.446.37002 Boehringer Ingelheim Investigational Site

City

Utena

Country

Lithuania

Facility Name

205.446.37001 Boehringer Ingelheim Investigational Site

City

Vilnius

Country

Lithuania

Facility Name

205.446.48004 Boehringer Ingelheim Investigational Site

City

Bialystok

Country

Poland

Facility Name

205.446.48002 Boehringer Ingelheim Investigational Site

City

Lodz

Country

Poland

Facility Name

205.446.48001 Boehringer Ingelheim Investigational Site

City

Lublin

Country

Poland

Facility Name

205.446.48003 Boehringer Ingelheim Investigational Site

City

Tarnow

Country

Poland

Facility Name

205.446.40002 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

205.446.70002 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

205.446.70005 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

205.446.70007 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

205.446.70011 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

205.446.70012 Boehringer Ingelheim Investigational Site

City

Novosibirsk

Country

Russian Federation

Facility Name

205.446.70001 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

205.446.70003 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

205.446.70004 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

205.446.70010 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

205.446.70009 Boehringer Ingelheim Investigational Site

City

Yaroslavl

Country

Russian Federation

Facility Name

205.446.42101 Boehringer Ingelheim Investigational Site

City

Kosice

Country

Slovakia

Facility Name

205.446.42103 Boehringer Ingelheim Investigational Site

City

Presov

Country

Slovakia

Facility Name

205.446.42102 Boehringer Ingelheim Investigational Site

City

Spisska Nova Ves

Country

Slovakia

Facility Name

205.446.38013 Boehringer Ingelheim Investigational Site

City

Chernivtsi

Country

Ukraine

Facility Name

205.446.38002 Boehringer Ingelheim Investigational Site

City

Dnipropetrovsk

Country

Ukraine

Facility Name

205.446.38003 Boehringer Ingelheim Investigational Site

City

Dnipropetrovsk

Country

Ukraine

Facility Name

205.446.38005 Boehringer Ingelheim Investigational Site

City

Donetsk

Country

Ukraine

Facility Name

205.446.38012 Boehringer Ingelheim Investigational Site

City

Donetsk

Country

Ukraine

Facility Name

205.446.38009 Boehringer Ingelheim Investigational Site

City

Kharkiv

Country

Ukraine

Facility Name

205.446.38004 Boehringer Ingelheim Investigational Site

City

Kiev

Country

Ukraine

Facility Name

205.446.38006 Boehringer Ingelheim Investigational Site

City

Kriviy Rig

Country

Ukraine

Facility Name

205.446.38001 Boehringer Ingelheim Investigational Site

City

Lviv

Country

Ukraine

Facility Name

205.446.38014 Boehringer Ingelheim Investigational Site

City

Odesa

Country

Ukraine

Facility Name

205.446.38010 Boehringer Ingelheim Investigational Site

City

Vinnytsya

Country

Ukraine

Facility Name

205.446.38011 Boehringer Ingelheim Investigational Site

City

Zaporizhya

Country

Ukraine

Facility Name

205.446.38008 Boehringer Ingelheim Investigational Site

City

Zaporizhzhya

Country

Ukraine

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com/

Description

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

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

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

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1. Study Identification

2. Study Status

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5. Study Description

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7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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