A Study to Evaluate Efficacy and Safety of Tiotropium in Children 6 to 11 Years Old With Moderate Asthma

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NCT01383499

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Study Location
205.425.49005 Boehringer Ingelheim Investigational Site
Bochum, , , Germany
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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
6-11 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:

1. All patients' parents (or legally accepted caregivers) must sign and date an informed consent prior to any study procedures including medication washout and restrictions. In addition, an informed assent suitable for this age group has to be obtained from patients.

2. Male or female patients between 6 and 11 years of age (up to 1 day prior to their 12th birthday at Visit 1).

3. All patients must have at least a 6-month history of asthma at the time of enrolment into the trial.

4. All patients must have been on maintenance treatment with inhaled corticosteroids at a stable medium dose - a patient is eligible on =200 µg to =400 µg Budesonide DPI or equivalent.

5. All patients must be symptomatic (partly controlled) at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an ACQ mean score of =1.5.

6. All patients must have a pre-bronchodilator FEV1 =60% and =90% of predicted normal at Visit 1. Variation of absolute FEV1 values of Visit 2 (pre-dose) as compared to values at Visit 2 (pre-bronchodilator) must be within ± 30%.

7. All patients must demonstrate an increase in FEV1 of =12% 15 to 30 min. after 200 µg salbutamol (albuterol) at Visit 1.

8. Patients must be able to inhale from the Respimat® inhaler correctly.

9. Patients must be able to perform all trial related procedures including technically acceptable spirometric manoeuvres according to current ATS/ERS standards and the use of the electronic diary/peak flow meter.

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


Patients with any of the following characteristics will not be eligible for entry into this
study:


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. For participation in PK sampling, a haemoglobin of less than
11.3 g/dL will be regarded as exclusion criterion.


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, catheter ablation
etc.) 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 within the last five years.


6. Patients with clinically significant lung diseases other than asthma, such as CF, or
bronchopulmonary dysplasia.


7. Patients with known active tuberculosis.


8. Patients who have undergone thoracotomy with pulmonary resection. Patients with a
history of thoracotomy for other reasons should be evaluated as per exclusion
criterion No. 1.


9. 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).


10. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other
components of the tiotropium inhalation solution.


11. Patients with known narrow-angle glaucoma, or any other disease where anticholinergic
treatment is contraindicated.


12. 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Efficacy and Safety of Tiotropium in Children 6 to 11 Years Old With Moderate Asthma
Official Title  ICMJE A Phase II Randomised, Double-blind, Placebo-controlled Incomplete Crossover Trial With 4-week Treatment Periods to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (Doses of 1.25 µg, 2.5 µg and 5 µg) Delivered Via Respimat® Inhaler Once Daily in the Evening in Children 6 to 11 Yrs Old With Moderate Persistent Asthma
Brief Summary The aim of this trial is to select an optimum dose may be selected based on bronchodilator efficacy, safety evaluations and pharmacokinetics of tiotropium bromide.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE Drug: Tiotropium bromide
inhalation solution administered via Respimat in 3 different doses
Study Arms  ICMJE
  • Experimental: Treatment A
    patients inhale 2 puffs (low dose) once daily in the evening via Respimat inhaler
    Intervention: Drug: Tiotropium bromide
  • Experimental: Treatment B
    patients inhale 2 puffs (medium dose) once daily in the evening via Respimat inhaler
    Intervention: Drug: Tiotropium bromide
  • Experimental: Treatment C
    patients inhale 2 puffs (high dose) once daily in the evening via Respimat inhaler
    Intervention: Drug: Tiotropium bromide
  • Placebo Comparator: Treatment D
    patients inhale 2 puffs of placebo inhalation solution matching tiotropium once daily in the evening via Respimat inhaler
    Intervention: Drug: Tiotropium bromide
Publications * Vogelberg C, Moroni-Zentgraf P, Leonaviciute-Klimantaviciene M, Sigmund R, Hamelmann E, Engel M, Szefler S. A randomised dose-ranging study of tiotropium Respimat® in children with symptomatic asthma despite inhaled corticosteroids. Respir Res. 2015 Feb 7;16:20. doi: 10.1186/s12931-015-0175-9. Erratum in: Respir Res. 2015;16:128.

*   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: June 27, 2012)		101
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2011)		92
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

Patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:

  1. All patients' parents (or legally accepted caregivers) must sign and date an informed consent prior to any study procedures including medication washout and restrictions. In addition, an informed assent suitable for this age group has to be obtained from patients.
  2. Male or female patients between 6 and 11 years of age (up to 1 day prior to their 12th birthday at Visit 1).
  3. All patients must have at least a 6-month history of asthma at the time of enrolment into the trial.
  4. All patients must have been on maintenance treatment with inhaled corticosteroids at a stable medium dose - a patient is eligible on =200 µg to =400 µg Budesonide DPI or equivalent.
  5. All patients must be symptomatic (partly controlled) at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an ACQ mean score of =1.5.
  6. All patients must have a pre-bronchodilator FEV1 =60% and =90% of predicted normal at Visit 1. Variation of absolute FEV1 values of Visit 2 (pre-dose) as compared to values at Visit 2 (pre-bronchodilator) must be within ± 30%.
  7. All patients must demonstrate an increase in FEV1 of =12% 15 to 30 min. after 200 µg salbutamol (albuterol) at Visit 1.
  8. Patients must be able to inhale from the Respimat® inhaler correctly.
  9. Patients must be able to perform all trial related procedures including technically acceptable spirometric manoeuvres according to current ATS/ERS standards and the use of the electronic diary/peak flow meter.

Exclusion criteria:

Patients with any of the following characteristics will not be eligible for entry into this study:

  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. For participation in PK sampling, a haemoglobin of less than 11.3 g/dL will be regarded as exclusion criterion.
  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, catheter ablation etc.) 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 within the last five years.
  6. Patients with clinically significant lung diseases other than asthma, such as CF, or bronchopulmonary dysplasia.
  7. Patients with known active tuberculosis.
  8. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1.
  9. 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).
  10. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the tiotropium inhalation solution.
  11. Patients with known narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated.
  12. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Hungary,   Latvia,   Lithuania,   Russian Federation,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01383499
Other Study ID Numbers  ICMJE 205.425
2010-022458-18 ( EudraCT Number )
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 March 2015

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