NCT03099902

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

4.8 years

First QC Date

March 22, 2017

Last Update Submit

April 10, 2017

Conditions

Asthma in ChildrenWheezing

Keywords

AsthmaWheezingGSTP1TNFaSecondhand smokingPassive smokingIntrauterine smoking

Outcome Measures

Primary Outcomes (1)

  • GSTP1 and TNFa variants in children with asthma

    0 days

Study Arms (2)

Cases

Children with asthma/wheezing whose mothers were active smokers during pregnancy

Diagnostic Test: Lung functionDiagnostic Test: White blood cell DNA extractionDiagnostic Test: Urinary testing

Controls

Children without asthma/wheezing whose mothers were active smokers during pregnancy

Diagnostic Test: Lung functionDiagnostic Test: White blood cell DNA extractionDiagnostic Test: Urinary testing

Interventions

Lung functionDIAGNOSTIC_TEST

Spirometry test

CasesControls
White blood cell DNA extractionDIAGNOSTIC_TEST

GSTP1 and TNFa polymorphisms with PCR

CasesControls
Urinary testingDIAGNOSTIC_TEST

Urinary nicotine and cotinine detection

CasesControls

Eligibility Criteria

Age12 Months - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects attending the Pediatric Outpatient Clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Respiratory SoundsAsthma

Interventions

Respiration

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc, Clinical Research Associate

Study Record Dates

First Submitted

March 22, 2017

First Posted

April 4, 2017

Study Start

November 1, 2010

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

April 11, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share