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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01179152
First received: August 9, 2010
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Asthma Exacerbation
Drug: Budesonide turbuhaler, Budesonide+Formoterol turbuhaler

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • reduction of asthma exacerbation during the study period [ Time Frame: An average time of 8 weeks ] [ Designated as safety issue: No ]
    less asthma exacerbation


Secondary Outcome Measures:
  • less primary care physician visits [ Time Frame: An average time of 8 weeks ] [ Designated as safety issue: No ]
    less primary care physician visits less ER visits less hospitalization due to asthma exacerbation


Estimated Enrollment: 225
Study Start Date: September 2010
Estimated Study Completion Date: October 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179152

Contacts
Contact: Avner He Cohen, MD 972-3-9398200 hermanc@post.tau.ac.il

Locations
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel
Contact: Avner He Cohen, MD         
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Avner He Cohen, Dr Clalit Health Services
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01179152     History of Changes
Other Study ID Numbers: hermanasthma
Study First Received: August 9, 2010
Last Updated: March 16, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Meir Medical Center:
asthma, september epidemic, children, preventive

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 09, 2014