Secondhand Smoking in Asthmatic Children

April 10, 2017 updated by: Maria Avgeri, AHEPA University Hospital

Association Between Maternal Smoking and GSTP1 and TNFa Polymorphism in Children With Asthma/Wheezing

This study will investigate the interaction between GSTP1 / TNFa polymorphisms and passive smoking in children with asthma/wheezing. Contemporary second hand-smoke exposure will be confirmed by laboratory testing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

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

1 year to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects attending the Pediatric Outpatient Clinic

Description

Inclusion Criteria:

  • Subjects 1-18 years old with doctor diagnosed asthma/wheezing

Exclusion Criteria:

  • Premature birth (< 36 gestation weeks)
  • Asthma-like symptoms due to other conditions (infectious, congenital, mechanical)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
Children with asthma/wheezing whose mothers were active smokers during pregnancy
Diagnostic test: Lung function
Spirometry test
Diagnostic test: White blood cell DNA extraction
GSTP1 and TNFa polymorphisms with PCR
Diagnostic test: Urinary testing
Urinary nicotine and cotinine detection
Controls
Children without asthma/wheezing whose mothers were active smokers during pregnancy
Diagnostic test: Lung function
Spirometry test
Diagnostic test: White blood cell DNA extraction
GSTP1 and TNFa polymorphisms with PCR
Diagnostic test: Urinary testing
Urinary nicotine and cotinine detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
GSTP1 and TNFa variants in children with asthma
Time Frame: 0 days
0 days

Collaborators and Investigators

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

Sponsor

AHEPA University Hospital

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 (ACTUAL)

November 1, 2010

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

March 22, 2017

First Submitted That Met QC Criteria

March 29, 2017

First Posted (ACTUAL)

April 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/1-3-2011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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