Combined Glucocorticoid Adrenergic Therapy For Wheezy Preschool Children

Phase 4

Withdrawn

• Conditions: Wheeze
• Interventions: Drug: Beclomethasone and Salbutamol; Drug: Beclomethasone; Drug: Placebo; Device: Aerochamber Max®

• Registration Number: NCT02319564
• Lead Sponsor: University of Calgary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-30
• Study First Submitted QC: 2014-12-13
• Study First Posted: 2014-12-18
• Study Start: 2016-04
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-11
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
beclomethasone	Aerochamber Max®	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 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.
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.
beclomethasone and salbutamol	Aerochamber Max®	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.
Placebo	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®	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.

Primary Outcome Measures

Name	Time	Method
Reduce unplanned-symptomatic visits to clinicians	After enrolment is complete

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada