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

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NCT01634113

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Study Location
205.443.12003 Boehringer Ingelheim Investigational Site
Columbia, Missouri, , United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Asthma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-5 year
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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).

Further inclusion criteria apply.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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).


Further exclusion criteria apply.

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: tiotropium-bromide
    IMP
  • Drug: placebo
    placebo matching tiotropium
Study Arms  ICMJE
  • Experimental: tiotropium low dose
    Once daily, delivered with Respimat® inhaler
    Intervention: Drug: tiotropium-bromide
  • Experimental: tiotropium high dose
    Once daily, delivered with Respimat® inhaler
    Intervention: Drug: tiotropium-bromide
  • Placebo Comparator: placebo
    Once daily, delivered with Respimat® inhaler
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2012)		102
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Further inclusion criteria apply.

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).

Further exclusion criteria apply.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 1 Year to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Finland,   Germany,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Netherlands,   Philippines,   Ukraine,   United States
Removed Location Countries Peru
 
Administrative Information
NCT Number  ICMJE NCT01634113
Other Study ID Numbers  ICMJE 205.443
2011-005512-28 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Boehringer IngelheimBoehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP