Trial for the Treatment of Acute Asthma in Wheezy Pre-school Aged Children

Study Overview
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Brief Summary
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To determine if treatment of pre-school children with a history of wheeze who present to an Emergency Department with an acute wheezing episode with azithromycin for 5 days will resolve their symptoms more quickly, will require less short acting beta agonist (SABA), and allow these children to remain symptom free for a longer period of time.

Official Title
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A Double Blind Randomized Control Trail of Azithromycin for the Acute Management of Wheezy Pre-school Children

Conditions
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Asthma

Intervention / Treatment
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* Drug: Azithromycin
* Drug: Suspension Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 12-60 months wheeze on auscultation Exclusion Criteria: antibiotic use in the past 30 days macrolide allergy underlying medical condition significant co-morbidities current enrollment language barrier or no access to phone for follow up

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: Zithromax, 100 mgmgs; 5mls suspension<br>Azithromycin given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days Each syringe will contain 12.5 mls (250 mgs) sufficient drug to adequately dose children who with up to 25 kgs (95%tile for weight for 60 month old child) | Drug: Azithromycin<br>* Azithromycin given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days Each syringe will contain 12.5 mls (250 mgs) sufficient drug to adequately dose children who with up to 25 kgs (95%tile for weight for 60 month old child)<br>* Other names: Azithromycin, zithromax, macrolide;|
| Placebo Comparator: Suspension placebo,<br>placebo (suspension produced by CDC Edmonton.) given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days. | Drug: Suspension Placebo<br>* Placebo suspension will be administered on day 1 at 10mg/kg and then for the next 4 days at 5 mg/kg<br>* Other names: Azithromycin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if treatment of pre-school children with a history of wheeze who present to an Emergency department (ED) with an acute wheezing episode with Azithromycin for 5 days will resolve their symptoms more quickly |  | Patient is followed by phone day 1,3,5,7,14, with an in person return visit on day 21 and then by phone again every 2 weeks for 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment of pre-school children with acute wheezing symptoms with 5 days of azithromycin will cause these children to use less rescue beta2 agonists than those treated with placebo |  | Patient is followed by phone day 1,3,5,7,14, with an in person return visit on day 21 and then by phone again every 2 weeks for 6 months | 
| Treatment of pre-school children with acute wheezing symptoms with 5 days of azithromycin will allow these children to remain free of subsequent wheezy episodes longer than those treated with placebo. |  | Patient is followed by phone day 1,3,5,7,14, with an in person return visit on day 21 and then by phone again every 2 weeks for 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-school child, Wheezy episode