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Clinical Trials/EUCTR2015-002985-22-FI
EUCTR2015-002985-22-FI
Active, not recruiting
Phase 1

Efficacy of Intermittent Tiotropium in Early Childhood Wheezing

Mika J. Mäkelä0 sites195 target enrollmentAugust 25, 2015
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ConditionsEarly childhood wheezingMedDRA version: 18.0Level: LLTClassification code 10047921Term: WheezeSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
DrugsSpiriva Respimat 2.5 microgramFlixotide Evohaler 125 microgramVentoline Evohaler 0.1 mg

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Early childhood wheezing
Sponsor
Mika J. Mäkelä
Enrollment
195
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 25, 2015
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Mika J. Mäkelä

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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