Preventive Medicine Study of Childhood Atopic Diseases

Healthy Clinical Trial

Official title:

Preventive Medicine Study of Childhood Atopic Diseases

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00960596
• Other study ID #: 200902042R
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 16, 2009
• Last updated: August 24, 2009
• Start date: July 2009
• Est. completion date: June 2010

Study information

• Verified date: August 2009
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

Under environmental intervention programs, to explore the associations between Environmental Tobacco Smoke (ETS) and changes of pulmonary function, cytokines and new-onset asthma between different groups.

Description:

Environmental intervention programs:

We will both interview by telephone and mail the health education leaflets, in order to achieve the following aims:

-Smokers living with the children will change where smoking takes place for reducing the children's ETS exposure.

Data collection:

We will contact participants individually to get informed consent before data collection. No matter what intervention, non-intervention or reference group, all participants will test as follows:

• Blood sample collection: We will test the total IgE, specific IgE, cytokines, such as IL-4, IL-13, TNF-α, ECP and EOS.

• Questionnaire collection

• Pulmonary function test

After intervention programs applied, all participants will test pulmonary function, and total IgE, specific IgE and cytokines by blood sample after six months by school approaches. Then, we can compare the pulmonary function, total IgE, specific IgE and cytokines before and after intervention programs.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Only one smokers living in the same household

• Having smoking exposure during the past 12 months while questionnaire surveying

• Child without smoking habit

Exclusion Criteria:

• None of above

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Health promotion and health education for smoking habits
We provide the education to intervention group.

Locations

Country	Name	City	State
Taiwan	National Taiwan University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urine cotinine level		six months, one year	No