Antibiotic Treatment of Recurrent Episodes of Asthma in Children

Study Overview
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Brief Summary
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Copsac has discovered that asthmatic exacerbations are as closely linked to bacterial as to viral infection. The current study will examine whether treatment of asthmatic exacerbations with macrolide antibiotics - in the abscence of clear clinical bacterial infection which would in any case precipitate antibiotic treatment - has an effect on either the particular episode, or subsequently. Macrolide antibiotics are chosen for ease of administration ensuring high compliance, antibiotic appropriacy, and anti-inflammatory properties.

Official Title
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Antibiotic Treatment of Recurrent Episode of Asthma in Children - a Randomised, Case-controlled Study Within the COPSAC2010 Cohort (Asthma Begins in Childhood)

Conditions
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Childhood Asthma With Acute Exacerbation

Intervention / Treatment
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* Drug: Azithromycin
* Other: Placebo mixture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participation in the COPSAC2010 cohort recurrent wheeze and others Exclusion Criteria: Macrolide allergy Heart, liver or kidney disease. and others

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 3 Years

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antibiotics<br>Azithromycin (10 mg/kg once a day for 3 days) | Drug: Azithromycin<br>* 10 mg/kg peroral for 3 consecutive days<br>|
| Placebo Comparator: Placebo<br>Placebo mixture (once a day for 3 days) | Other: Placebo mixture<br>* Placebo mixture containing no active substance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom scoring |  | 1 to 3 years of age | 
| Duration in days of each asthmatic episode from randomisation start |  | 1 to 3 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need for PO steroids during the episode |  | 1 to 3 years of age | 
| beta-agonist use during the asthmatic episode |  | 1 to 3 years of age | 
| time lapse until the next asthmatic episode |  | 1 to 3 years of age | 
| MD assessment of the episode |  | 1 to 3 years of age | 
| Family's assessment of the episode |  | 1 to 3 years of age | 
| Asthma related health and economic assessment |  | 1 to 3 years of age | 
| percentage of time away from kindergarten or, for the parents, away from work |  | 1 to 3 years of age | 
| stratification of the above parameters according to bacterial colonisation of the airways |  | 1 to 3 years of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wheeze, infections