Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Secondhand Smoking in Asthmatic Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099902
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Maria Avgeri, AHEPA University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Asthma in Children Wheezing Diagnostic Test: Lung function Diagnostic Test: White blood cell DNA extraction Diagnostic Test: Urinary testing

Layout table for study information
Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Association Between Maternal Smoking and GSTP1 and TNFa Polymorphism in Children With Asthma/Wheezing
Actual Study Start Date : November 1, 2010
Actual Primary Completion Date : September 1, 2015
Actual Study Completion Date : September 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Smoking

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




Primary Outcome Measures :
  1. GSTP1 and TNFa variants in children with asthma [ Time Frame: 0 days ]

Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects attending the Pediatric Outpatient Clinic
Criteria

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)
Layout table for additonal information
Responsible Party: Maria Avgeri, MD, MSc, Clinical Research Associate, AHEPA University Hospital
ClinicalTrials.gov Identifier: NCT03099902    
Other Study ID Numbers: 14/1-3-2011
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Avgeri, AHEPA University Hospital:
Asthma
Wheezing
GSTP1
TNFa
Secondhand smoking
Passive smoking
Intrauterine smoking
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Respiratory Sounds
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Signs and Symptoms, Respiratory