Efficacy of Intermittent Tiotropium in Early Childhood Wheezing

Phase 1

• Conditions: Early childhood wheezing; MedDRA version: 18.0Level: LLTClassification code 10047921Term: WheezeSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-002985-22-FI
• Lead Sponsor: Mika J. Mäkelä

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-25
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 195

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified