Study of Preventive Treatment With Symbicort or Budicort Turbohaler in Childhood Asthma Return to School Epidemic
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
1 other identifier
interventional
225
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2010
CompletedFirst Posted
Study publicly available on registry
August 11, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedMarch 19, 2012
March 1, 2012
1.1 years
August 9, 2010
March 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
reduction of asthma exacerbation during the study period
less asthma exacerbation
An average time of 8 weeks
Secondary Outcomes (1)
less primary care physician visits
An average time of 8 weeks
Study Arms (3)
Budicort
ACTIVE COMPARATOR75 children will receive treatment with Budicort 200 mcg
Symbicort
ACTIVE COMPARATOR75 children will receive treatment with Symbicort 160 mcg
counselling
NO INTERVENTION75 children who will not treated as their request but will be folowedup
Interventions
Budesonide 200 mcg turbuhaler or Budesonide+Formoterol 160mcg turbuhaler
Eligibility Criteria
You may qualify if:
- age : 6-18 years suffering from asthma asthma exacerbation during 1/9/2009-15/10/2009
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Meir Medical Center
Kfar Saba, Israel
Related Publications (1)
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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Avner He Cohen, Dr
Clalit Health Services
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2010
First Posted
August 11, 2010
Study Start
September 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2012
Last Updated
March 19, 2012
Record last verified: 2012-03