A Study to Evaluate Efficacy and Safety of Tiotropium in Children 6 to 11 Years Old With Moderate Asthma
NCT01383499
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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.
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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Descriptive Information | ||||
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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 |
| |||
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 | 101 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion criteria: Patients with any of the following characteristics will not be eligible for entry into this study:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |