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

Not Applicable

• Conditions: Asthma Exacerbation
• Interventions: Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler

• Registration Number: NCT01179152
• Lead Sponsor: Meir Medical Center

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.

Study Timeline

• Study First Submitted: 2010-08-09
• Study First Submitted QC: 2010-08-10
• Study First Posted: 2010-08-11
• Study Start: 2010-09
• Primary Completion: 2011-10
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-16
• Last Update Posted: 2012-03-19
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 225

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Symbicort	Budesonide turbuhaler, Budesonide+Formoterol turbuhaler	75 children will receive treatment with Symbicort 160 mcg
counselling	Budesonide turbuhaler, Budesonide+Formoterol turbuhaler	75 children who will not treated as their request but will be folowedup
Budicort	Budesonide turbuhaler, Budesonide+Formoterol turbuhaler	75 children will receive treatment with Budicort 200 mcg

Primary Outcome Measures

Name	Time	Method
reduction of asthma exacerbation during the study period	An average time of 8 weeks	less asthma exacerbation

Secondary Outcome Measures

Name	Time	Method
less primary care physician visits	An average time of 8 weeks	less primary care physician visits less ER visits less hospitalization due to asthma exacerbation

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel