Efficacy of Intermittent Tiotropium in Early Childhood Wheezing
Wheezy Bronchitis, Asthmatic Bronchitis, Wheezing
About this trial
This is an interventional treatment trial for Wheezy Bronchitis focused on measuring wheeze, shortness of breath
Eligibility Criteria
Inclusion Criteria:
- Children at the age of 6 to 35 months.
- Two to four physician-confirmed episodes of wheeze and/or shortness of breath.
- Parents/legal representatives with sufficient written and spoken skills in Finnish language.
Exclusion Criteria:
- Birth before 36th week of gestation.
- Suspected/diagnosed chronic parenchymal lung disease or a structural airway defect, or a history of thoracotomy with pulmonary resection.
- A history of congenital or acquired heart disease, including any unstable or life-threatening cardiac arrhythmia.
- Constipation with a need of regular medication, or a diagnosed/suspected structural defect in the gastrointestinal tract.
- A history of malignancy, or other significant chronic disorder, disease, or defect.
Sites / Locations
- Skin and Allergy Hospital, Helsinki University Hospital, Helsinki, Finland
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Tiotropium Bromide & Salbutamol
Fluticasone Propionate & Salbutamol
Salbutamol
Inhaled Tiotropium Bromide 5 µg once a day, beginning at the onset of an upper respiratory tract infection and continuing for 7 to 14 days as needed, and inhaled Salbutamol 0.2 mg 4 to 6 times a day as needed for wheeze and shortness of breath
Inhaled Fluticasone Propionate 125 µg twice a day, beginning at the onset of an upper respiratory tract infection and continuing for 7 to 14 days as needed, and inhaled Salbutamol 0.2 mg 4 to 6 times a day as needed for wheeze and shortness of breath
Inhaled Salbutamol 0.2 mg 4 to 6 times a day as needed for wheeze and shortness of breath