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

Primary Purpose

Asthma Exacerbation

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Budesonide turbuhaler, Budesonide+Formoterol turbuhaler
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma Exacerbation focused on measuring asthma, september epidemic, children, preventive

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Meir Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Budicort

Symbicort

counselling

Arm Description

75 children will receive treatment with Budicort 200 mcg

75 children will receive treatment with Symbicort 160 mcg

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

Outcomes

Primary Outcome Measures

reduction of asthma exacerbation during the study period
less asthma exacerbation

Secondary Outcome Measures

less primary care physician visits
less primary care physician visits less ER visits less hospitalization due to asthma exacerbation

Full Information

First Posted
August 9, 2010
Last Updated
March 16, 2012
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01179152
Brief Title
Study of Preventive Treatment With Symbicort or Budicort Turbohaler in Childhood Asthma Return to School Epidemic
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma Exacerbation
Keywords
asthma, september epidemic, children, preventive

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Budicort
Arm Type
Active Comparator
Arm Description
75 children will receive treatment with Budicort 200 mcg
Arm Title
Symbicort
Arm Type
Active Comparator
Arm Description
75 children will receive treatment with Symbicort 160 mcg
Arm Title
counselling
Arm Type
No Intervention
Arm Description
75 children who will not treated as their request but will be folowedup
Intervention Type
Drug
Intervention Name(s)
Budesonide turbuhaler, Budesonide+Formoterol turbuhaler
Other Intervention Name(s)
Budesonide turbuhaler, Budesonide+Formoterol turbuhaler
Intervention Description
Budesonide 200 mcg turbuhaler or Budesonide+Formoterol 160mcg turbuhaler
Primary Outcome Measure Information:
Title
reduction of asthma exacerbation during the study period
Description
less asthma exacerbation
Time Frame
An average time of 8 weeks
Secondary Outcome Measure Information:
Title
less primary care physician visits
Description
less primary care physician visits less ER visits less hospitalization due to asthma exacerbation
Time Frame
An average time of 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avner He Cohen, MD
Phone
972-3-9398200
Email
hermanc@post.tau.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avner He Cohen, Dr
Organizational Affiliation
Clalit Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avner He Cohen, MD

12. IPD Sharing Statement

Citations:
Citation
Johnston NJ, Johnston SL, Duncan JM, Greene JM,Keith PK,Roy M, Wsaerman S, Sears MR. The september epidemic of asthma exacerbation in children:a search for etiology. J allergy Clin Immunol 2005,115;132-8 Scheuerman O, Meyerowitch J, Marcus N, Hoffer V, Batt E , Garty B-Z. The september epidemic of asthma in Israel. J of Asthma 2009;46;652-5 Johnston NW, Mandhane PJ, Dai J, Duncan JM, Greene JM,Lambert K, Sears Mr. Attenuation of the september epidemic of asthma exacerbation in children: A randomized controlled trial of montelukast added to usual therapy. Pediatrics;120;e702-e712.
Results Reference
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Study of Preventive Treatment With Symbicort or Budicort Turbohaler in Childhood Asthma Return to School Epidemic

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