Combined Glucocorticoid Adrenergic Therapy For Wheezy Preschool Children

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Trial Assessing the Effectiveness of Beclomethasone and Combination Beclomethasone and Salbutamol as Compared With Placebo in Preschool Aged Children With Wheeze

Conditions
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Wheeze

Intervention / Treatment
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* Drug: Beclomethasone
* Drug: Beclomethasone and Salbutamol
* Drug: Placebo
* Device: Aerochamber Max®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: beclomethasone<br>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. | Drug: Beclomethasone<br> <br> * Other names: Clenil;Device: Aerochamber Max®<br> <br> * Other names: Masked Spacer for metered dose inhaler;|
| Active Comparator: beclomethasone and salbutamol<br>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. | Drug: Beclomethasone and Salbutamol<br> <br> * Other names: Clenil Compositum;Device: Aerochamber Max®<br> <br> * Other names: Masked Spacer for metered dose inhaler;|
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br> <br> Device: Aerochamber Max®<br> <br> * Other names: Masked Spacer for metered dose inhaler;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduce unplanned-symptomatic visits to clinicians |  | After enrolment is complete | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wheeze, Asthma, Randomized Trial, Pre-school aged children