Efficacy of Intermittent Tiotropium in Early Childhood Wheezing

• Status: Completed
• Trial end date: 2020-11-18
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the effect of intermittent tiotropium bromide and salbutamol as needed versus intermittent fluticasone propionate and salbutamol as needed, or solely, salbutamol as needed on episode-free days in infants and toddlers with recurrent episodes of wheeze and/or shortness of breath.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helsinki University Central Hospital
• Treatments: Albuterol; Bromides; Fluticasone; Tiotropium Bromide; Xhance

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.

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.