Study of Preventive Treatment With Symbicort or Budicort Turbohaler in Childhood Asthma Return to School Epidemic

Study Overview
=================
Brief Summary
-----------------
During the second week of September( week 38 of the year)there are recorded data of exacerbation of asthma all over the world, including Israel. A short preventive treatment of 6 weeks may reduce asthma exacerbation in children,reduce primary care and ER visiting and hospitalization.

Detailed Description
-----------------
During the second week of September( week 38 of the year)there are recorded data of exacerbation of asthma all over the world, including Israel. A short preventive treatment of 6 weeks may reduce asthma exacerbation in children,reduce primary care and ER visiting and hospitalization. We will study the effectiveness of Budicort or Symbicort turbuhaler as a preventive treatment in children aged 6-18 years.

Official Title
-----------------
Childhood Asthma and Return to School: the September Epidemic Exacerbation in Israel.A Controlled Trial of the Effectiveness of Preventive Treatment With Symbicort or Budicort Turbuhaler

Conditions
-----------------
Asthma Exacerbation

Intervention / Treatment
-----------------
* Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age : 6-18 years suffering from asthma asthma exacerbation during 1/9/2009-15/10/2009 - Exclusion Criteria: any chronic condition that can involve respiratory tract (other than asthma) treated as prevention with ICS or montelukast from July 2010 Treated with oral steroids during the August 2010 asthma exacerbation one week prior study inclusion

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Budicort<br>75 children will receive treatment with Budicort 200 mcg | Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler<br>* Budesonide 200 mcg turbuhaler or Budesonide+Formoterol 160mcg turbuhaler<br>* Other names: Budesonide+Formoterol turbuhaler;|
| Active Comparator: Symbicort<br>75 children will receive treatment with Symbicort 160 mcg | Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler<br>* Budesonide 200 mcg turbuhaler or Budesonide+Formoterol 160mcg turbuhaler<br>* Other names: Budesonide+Formoterol turbuhaler;|
| No Intervention: counselling<br>75 children who will not treated as their request but will be folowedup | Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler<br>* Budesonide 200 mcg turbuhaler or Budesonide+Formoterol 160mcg turbuhaler<br>* Other names: Budesonide+Formoterol turbuhaler;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of asthma exacerbation during the study period | less asthma exacerbation | An average time of 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| less primary care physician visits | less primary care physician visits less ER visits less hospitalization due to asthma exacerbation | An average time of 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, september epidemic, children, preventive