Early childhood wheezing MedDRA version: 18.0 Level: LLT Classification code 10047921 Term: Wheeze System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Spiriva Respimat 2.5 microgram
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: TIOTROPIUM BROMIDE
CAS Number: 139404-48-1
Concentration unit: µg microgram(s)
Concentration ty
Sponsors
Mika J. Mäkelä
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Children at the age of 6 to 35 months. 2. Two to four physician-confirmed episodes of wheeze and/or shortness of breath. 3. Parents/legal representatives with sufficient written and spoken skills in Finnish language Are the trial subjects under 18? yes Number of subjects for this age range: 195 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Birth before 36th week of gestation. 2. Suspected/diagnosed chronic parenchymal lung disease or a structural airway defect, or a history of thoracotomy with pulmonary resection. 3. A history of congenital or acquired heart disease, including any unstable or life-threatening cardiac arrhythmia. 4. Constipation with a need of regular medication, or a diagnosed/suspected structural defect in the gastrointestinal tract. 5. A history of malignancy, or other significant chronic disorder, disease, or defect.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary AIM of the study is 1) to find out the effect of intermittent tiotropium bromide and salbutamol as needed (TBS) versus intermittent fluticasone propionate and salbutamol as needed (FPS), or solely, salbutamol as needed (SA) on episode-free days in infants and toddlers with recurrent episodes of wheeze and/or shortness of breath. Episode-free days are defined as those days during which there are no symptoms of wheeze and/or shortness of breath, no unscheduled medical visits for wheeze and/or shortness of breath, and no use of rescue or supplementary controller medications. ;Secondary Objective: The secondary AIMS of the study are to find out the effect of TBS versus FPS or SA treatment on 1) the number of unscheduled physician visits for episodes of wheeze and/or shortness of breath, 2) the need for bronchodilative (rescue) medication, 3) levels of inflammation markers, and to evaluate 4) the safety of TBS versus FPS or SA treatment by paying attention to possible adverse events during treatment in infants and toddlers with recurrent episodes of wheeze and/or shortness of breath. ;Primary end point(s): The number of episode-free days in the study subjects. Episode-free days are defined as those days during which there are no symptoms of wheeze and/or shortness of breath, no unscheduled medical visits for wheeze and/or shortness of breath, and no use of rescue or supplementary controller medications. ;Timepoint(s) of evaluation of this end point: 48 weeks from the beginning of intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of unscheduled physician visits for episodes of wheeze and/or shortness of breath, need for bronchodilative (rescue) medication, levels of inflammation markers, and occurrence of adverse events during intervention in the study subjects. ;Timepoint(s) of evaluation of this end point: 48 weeks from the beginning of intervention. | — |
Countries
Finland
Contacts
Public ContactPaediatric Unit -- Trials
Department of Allergology, Helsinki University Hospital
Outcome results
None listed