Combined Glucocorticoid Adrenergic Therapy For Wheezy Preschool Children

• Status: Withdrawn
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators goal is to conduct a pilot randomized controlled trial (RCT) whose purpose is to determine the feasibility of a randomized trial designed to determine if either inhaled beclomethasone or a combination of inhaled beclomethasone/salbutamol (Clenil Compositum) are superior to placebo in treating pre-school aged children with an acute wheezing episode.

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

Details

• Lead Sponsor: University of Calgary
• Collaborator: Children's Hospital of Eastern Ontario
• Treatments: Albuterol; Beclomethasone

Criteria

Inclusion Criteria:

1. children 12-60 months of age

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:

1. treatment with oral or parenteral corticosteroids in the last 14 days

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