Combined Glucocorticoid Adrenergic Therapy For Wheezy Preschool Children (CONjuGATE)

University of Calgary

Status and phase: Withdrawn; Phase 4

Conditions: Wheeze

Treatments: Drug: Beclomethasone and Salbutamol; Drug: Beclomethasone; Drug: Placebo; Device: Aerochamber Max®

Study type: Interventional

Funder types: Other

Identifiers

NCT02319564

ConRCT1

Details and patient eligibility

About

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.

Sex: All

Ages: 12 to 60 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

beclomethasone

Active Comparator group

Description:

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.

Treatment:

Device: Aerochamber Max®

Drug: Beclomethasone

beclomethasone and salbutamol

Active Comparator group

Description:

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.

Treatment:

Device: Aerochamber Max®

Drug: Beclomethasone and Salbutamol

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Device: Aerochamber Max®

Drug: Placebo