Randomized Trial Assessing the Effectiveness of Beclomethasone and Combination Beclomethasone and Salbutamol as Compared With Placebo in Preschool Aged Children With Wheeze
Overview
- Phase
- Phase 4
- Intervention
- Placebo
- Conditions
- Wheeze
- Sponsor
- University of Calgary
- Locations
- 1
- Primary Endpoint
- Reduce unplanned-symptomatic visits to clinicians
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
David W Johnson
Professor, Departments of Pediatrics, Pharmacology & Physiology
University of Calgary
Eligibility Criteria
Inclusion Criteria
- •children 12-60 months of age
- •wheeze on auscultation
- •mild respiratory distress as measured by a score of \< 3 on the Pediatric Respiratory Assessment Measure (PRAM)
- •discharged home after evaluation by their ED physician.
Exclusion Criteria
- •treatment with oral or parenteral corticosteroids in the last 14 days
- •treatment with more than 2 doses of inhaled corticosteroids in the previous seven days
- •presence of a severe co-morbidity such as bronchopulmonary dysplasia, cystic fibrosis, congenital heart disease, adrenal disorder or immune deficiency
- •previously enrolled into this study or concurrently enrolled in another intervention trial
- •lack of telephone access or presence of a significant language barrier
Arms & Interventions
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.
Intervention: Placebo
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.
Intervention: Beclomethasone
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.
Intervention: 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.
Intervention: Beclomethasone and Salbutamol
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.
Intervention: 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.
Intervention: Aerochamber Max®
Outcomes
Primary Outcomes
Reduce unplanned-symptomatic visits to clinicians
Time Frame: After enrolment is complete
Secondary Outcomes
- Reduce the number of days with respiratory symptoms(Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days)
- Reduce the need for rescue salbutamol use(Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days)
- Reduce hospitalization rates of target population(Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days)
- Reduce overall societal health care costs of target population(Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days)