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

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Clalit Health Services

Status

Unknown

Conditions

Asthma Exacerbation

Treatments

Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler

Study type

Interventional

Funder types

Other

Identifiers

NCT01179152
hermanasthma

Details and patient eligibility

About

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.

Full 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.

Enrollment

225 estimated patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

225 participants in 3 patient groups

Budicort
Active Comparator group
Description:
75 children will receive treatment with Budicort 200 mcg
Treatment:
Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler
Symbicort
Active Comparator group
Description:
75 children will receive treatment with Symbicort 160 mcg
Treatment:
Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler
counselling
No Intervention group
Description:
75 children who will not treated as their request but will be folowedup
Treatment:
Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler

Trial contacts and locations

1

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Central trial contact

Avner He Cohen, MD

Data sourced from clinicaltrials.gov

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