Secondhand Smoking in Asthmatic Children | NCT03099902

Studies
Secondhand Smoking in Asthmatic Children

NCT03099902

Sponsor

AHEPA University Hospital

Status

Completed

Last Update Posted

Apr 11, 2017Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Asthma in Children
Wheezing

Interventions

Lung function
White blood cell DNA extraction
Urinary testing

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2010Actual

Primary Completion Date

Sep 1, 2015Actual

Completion Date

Sep 1, 2015Actual

First Submitted Date

Mar 22, 2017

First Submission Date that Met QC Criteria

Mar 29, 2017

First Posted Date

Apr 4, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2017

Last Update Posted Date

Apr 11, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maria Avgeri, MD, MSc, Clinical Research Associate, AHEPA University HospitalPrincipal Investigator

Lead Sponsor

AHEPA University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cases		Children with asthma/wheezing whose mothers were active smokers during pregnancy	Diagnostic Test: Lung function Diagnostic Test: White blood cell DNA extraction Diagnostic Test: Urinary testing
Controls		Children without asthma/wheezing whose mothers were active smokers during pregnancy	Diagnostic Test: Lung function Diagnostic Test: White blood cell DNA extraction Diagnostic Test: Urinary testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lung function	Diagnostic Test	Spirometry test	Cases Controls

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

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Subjects attending the Pediatric Outpatient Clinic

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012135	Respiratory Sounds
D001249	Asthma

Ancestor Terms

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001982	Bronchial Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012119	Respiration

Ancestor Terms

ID	Term
D012143	Respiratory Physiological Phenomena
D002943	Circulatory and Respiratory Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided