Combined Glucocorticoid Adrenergic Therapy For Wheezy Preschool Children
NCT ID: NCT02319564
Last Updated: 2016-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2016-04-30
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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beclomethasone
beclomethasone dipropionate 250mcg per puff per puff (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days.
Non-identifiable MDI prepared by Chiesi Farmaceutici Inc.
Beclomethasone
Aerochamber Max®
beclomethasone and salbutamol
beclomethasone diprionate 250mcg and salbutamol 100mcg per puff (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days.
Non-identifiable MDI prepared by Chiesi Farmaceutici Inc.
Beclomethasone and Salbutamol
Aerochamber Max®
Placebo
placebo (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days.
Non-identifiable MDI prepared by Chiesi Farmaceutici Inc.
Placebo
Aerochamber Max®
Interventions
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Beclomethasone
Beclomethasone and Salbutamol
Placebo
Aerochamber Max®
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. wheeze on auscultation
3. mild respiratory distress as measured by a score of \< 3 on the Pediatric Respiratory Assessment Measure (PRAM)
4. discharged home after evaluation by their ED physician.
Exclusion Criteria
2. treatment with more than 2 doses of inhaled corticosteroids in the previous seven days
3. presence of a severe co-morbidity such as bronchopulmonary dysplasia, cystic fibrosis, congenital heart disease, adrenal disorder or immune deficiency
4. previously enrolled into this study or concurrently enrolled in another intervention trial
5. lack of telephone access or presence of a significant language barrier
12 Months
60 Months
ALL
No
Sponsors
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Children's Hospital of Eastern Ontario
OTHER
University of Calgary
OTHER
Responsible Party
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David W Johnson
Professor, Departments of Pediatrics, Pharmacology & Physiology
Locations
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Alberta Children's Hospital
Calgary, Alberta, Canada
Countries
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Other Identifiers
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ConRCT1
Identifier Type: -
Identifier Source: org_study_id