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

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.

Study Overview

• Status: Unknown
• Conditions: Asthma Exacerbation
• Intervention / Treatment: Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler

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 Type: Interventional
• Enrollment (Anticipated): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Avner He Cohen, MD; Phone Number: 972-3-9398200; Email: hermanc@post.tau.ac.il

Study Locations

• Israel
  • Kfar Saba, Israel
    • Recruiting
    • Meir Medical Center
    • Contact: Avner He Cohen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

age : 6-18 years suffering from asthma asthma exacerbation during 1/9/2009-15/10/2009

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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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Budicort; 75 children will receive treatment with Budicort 200 mcg	Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler; Budesonide 200 mcg turbuhaler or Budesonide+Formoterol 160mcg turbuhaler; Other Names: Budesonide turbuhaler; Budesonide+Formoterol turbuhaler
Active Comparator: Symbicort; 75 children will receive treatment with Symbicort 160 mcg	Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler; Budesonide 200 mcg turbuhaler or Budesonide+Formoterol 160mcg turbuhaler; Other Names: Budesonide turbuhaler; Budesonide+Formoterol turbuhaler
No Intervention: counselling; 75 children who will not treated as their request but will be folowedup	Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler; Budesonide 200 mcg turbuhaler or Budesonide+Formoterol 160mcg turbuhaler; Other Names: Budesonide turbuhaler; Budesonide+Formoterol turbuhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reduction of asthma exacerbation during the study period	less asthma exacerbation	An average time of 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
less primary care physician visits	less primary care physician visits less ER visits less hospitalization due to asthma exacerbation	An average time of 8 weeks

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Principal Investigator: Avner He Cohen, Dr, Clalit Health Services

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: August 9, 2010
• First Submitted That Met QC Criteria: August 10, 2010
• First Posted (Estimate): August 11, 2010

Study Record Updates

• Last Update Posted (Estimate): March 19, 2012
• Last Update Submitted That Met QC Criteria: March 16, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: asthma, september epidemic, children, preventive
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Budesonide; Formoterol Fumarate
• Other Study ID Numbers: hermanasthma