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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma Exacerbation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Budicort

75 children will receive treatment with Budicort 200 mcg

Group Type ACTIVE_COMPARATOR

Budesonide turbuhaler, Budesonide+Formoterol turbuhaler

Intervention Type DRUG

Budesonide 200 mcg turbuhaler or Budesonide+Formoterol 160mcg turbuhaler

Symbicort

75 children will receive treatment with Symbicort 160 mcg

Group Type ACTIVE_COMPARATOR

Budesonide turbuhaler, Budesonide+Formoterol turbuhaler

Intervention Type DRUG

Budesonide 200 mcg turbuhaler or Budesonide+Formoterol 160mcg turbuhaler

counselling

75 children who will not treated as their request but will be folowedup

Group Type NO_INTERVENTION

Budesonide turbuhaler, Budesonide+Formoterol turbuhaler

Intervention Type DRUG

Budesonide 200 mcg turbuhaler or Budesonide+Formoterol 160mcg turbuhaler

Interventions

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Budesonide turbuhaler, Budesonide+Formoterol turbuhaler

Budesonide 200 mcg turbuhaler or Budesonide+Formoterol 160mcg turbuhaler

Intervention Type DRUG

Other Intervention Names

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Budesonide turbuhaler Budesonide+Formoterol turbuhaler

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No