Preventive Medicine Study of Childhood Atopic Diseases

August 24, 2009 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10020
        • National Taiwan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
urine cotinine level
Time Frame: six months, one year
six months, one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Science Council, Taiwan

Investigators

  • Principal Investigator: YungLing Lee, Dr., Institute of Preventive Medicine, College of Public Health, National Taiwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

August 16, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (Estimate)

August 18, 2009

Study Record Updates

Last Update Posted (Estimate)

August 25, 2009

Last Update Submitted That Met QC Criteria

August 24, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 200902042R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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