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

Asthma Exacerbation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01179152
• Other study ID #: hermanasthma
• Status: Recruiting
• Phase: N/A
• First received: August 9, 2010
• Last updated: March 16, 2012
• Start date: September 2010
• Est. completion date: October 2012

Study information

• Verified date: March 2012
• Source: Meir Medical Center
• Contact: Avner He Cohen, MD
• Phone: 972-3-9398200
• Email: hermanc[@]post.tau.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: October 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma
• Asthma Exacerbation

Intervention

Drug:
• Budesonide turbuhaler, Budesonide+Formoterol turbuhaler
Budesonide 200 mcg turbuhaler or Budesonide+Formoterol 160mcg turbuhaler

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of asthma exacerbation during the study period	less asthma exacerbation	An average time of 8 weeks	No
Secondary	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	No