Children (6-12 years old) with bronchopulmonary dysplasia MedDRA version: 21.1 Level: PT Classification code 10006475 Term: Bronchopulmonary dysplasia System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Spiriva Respimat
Pharmaceutical Form: Inhalation solution
Pharmaceutical form of the placebo: Inhalation solution
Route of administration of the placebo: Inhalation use
Sponsors
Technische Universität Dresden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. the presence of bronchopulmonary dysplasia 2. formerly prematurely born male and female patients aged 6 to 12 years 3. informed consent of the guardians of the participating patients, confirmed by handwritten dating and signature, after information has been provided and the consent of the participating patients, confirmed and obtained by signature 4. FEV1 before inhalation of a betamimetic >60% and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. hypersensitivity to tiotropium or its ingredients or to drugs with a similar chemical structure, as known from medical history 2. participation of the patient in another clinical trial within the last 4 weeks before inclusion 3. indications that the patient is unlikely to comply with the protocol (e.g., lack of cooperation) 4. contraindications according to the Spiriva® Respimat® technical information 5. presence of bronchial asthma 6. presence of allergic sensitization to regionally typical respiratory allergens 7. therapy with inhaled steroid within the last 4 weeks 8. therapy with short- or long-acting inhaled betamimetic within the last 4 weeks 9. therapy with leukotriene antagonists within the last 4 weeks 10. therapy with inhaled anticholinergic within the last 4 weeks 11. girls of childbearing age (defined from Tanner stage = B3)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the clinical efficacy on lung function (FEV1 peak (0-1h)) of a daily inhalation of 5 µg tiotropium via Respimat® inhaler in 6-12 year old children with bronchopulmonary dysplasia;Secondary Objective: To study the safety and effect of daily inhalation of 5 µg of tiotropium via Respimat® inhaler in 6-12 year old children with bronchopulmonary dysplasia on various lung function parameters and physical activity, measured by the Physical Activity Questionnaire for Children (PAQ-C);Primary end point(s): Change in FEV1 peak (0-1 h) after 12 weeks of treatment;Timepoint(s) of evaluation of this end point: after 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): AEs and SAEs Change in FEV1 before inhalation after 12 weeks of treatment FVC peak (0-1h) after inhalation FEV1 (AUC(0-1h) and FVC (AUC(0-1h) Change FEV1/FVC Change MEF75-25 Change FVC Change before inhalation PEF am/pm Change PEF Change in variability Physical Activity Questionnaire for Children (PAQ-C) Difference FEV1, FVC, MEF75-25 before/after standardized treadmill provocation ;Timepoint(s) of evaluation of this end point: after 12 weeks of treatment | — |
Countries
Germany
Contacts
Public ContactKKS
Technische Universität Dresden
Outcome results
None listed