Asthma in ChildrenNCT03099902
Secondhand Smoking in Asthmatic Children
An observational study of Asthma in Children and Wheezing, run by AHEPA University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children, Wheezing
- What is being tested?
- Lung function, White blood cell DNA extraction and Urinary testing
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2010to 1 Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Subjects attending the Pediatric Outpatient Clinic
Who may be able to join
- Subjects 1-18 years old with doctor diagnosed asthma/wheezing
Who cannot join
- Premature birth (< 36 gestation weeks)
- Asthma-like symptoms due to other conditions (infectious, congenital, mechanical)
About this study
Official title: 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.
- Conditions
- Asthma in Children, Wheezing
- Being tested
- Lung function, White blood cell DNA extraction, Urinary testing
- Keywords
- Asthma, Wheezing, GSTP1, TNFa, Secondhand smoking, Passive smoking, Intrauterine smoking
- Medical subject headings
- Respiratory Sounds, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung functionDiagnostic test
Spirometry test
White blood cell DNA extractionDiagnostic test
GSTP1 and TNFa polymorphisms with PCR
Urinary testingDiagnostic test
Urinary nicotine and cotinine detection
| Study group | Role | What they receive |
|---|---|---|
| Cases | Children with asthma/wheezing whose mothers were active smokers during pregnancy Receives: 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 Receives: Diagnostic Test: Lung function; Diagnostic Test: White blood cell DNA extraction; Diagnostic Test: Urinary testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
GSTP1 and TNFa variants in children with asthma
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Nov 2010
- Primary completion1 Sep 2015
- Study completion1 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHEPA University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Avgeri, AHEPA University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099902
- Sponsor's protocol ID
- 14/1-3-2011
- Status last verified
- Apr 2017
- First submitted
- 22 Mar 2017
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Maternal Smoking and GSTP1 and TNFa Polymorphism in Children With Asthma/Wheezing
- ClinicalTrials.gov ID
- NCT03099902
- Acronym / sponsor ID
- 14/1-3-2011
- Conditions
- Asthma in Children, Wheezing
- Keywords
- Asthma, Wheezing, GSTP1, TNFa, Secondhand smoking, Passive smoking, Intrauterine smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- AHEPA University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2010 (actual)
- Primary completion
- 1 Sep 2015 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: Lung function, Diagnostic Test: White blood cell DNA extraction, Diagnostic Test: Urinary testingChildren with asthma/wheezing whose mothers were active smokers during pregnancy |
| Controls | – | Diagnostic Test: Lung function, Diagnostic Test: White blood cell DNA extraction, Diagnostic Test: Urinary testingChildren without asthma/wheezing whose mothers were active smokers during pregnancy |
Who may qualify
- Ages
- 12 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Subjects attending the Pediatric Outpatient Clinic
Key inclusion criteria (1 listed)
- Subjects 1-18 years old with doctor diagnosed asthma/wheezing
Key exclusion criteria (2 listed)
- Premature birth (< 36 gestation weeks)
- Asthma-like symptoms due to other conditions (infectious, congenital, mechanical)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung functionSpirometry test | Diagnostic test | Cases, Controls |
| White blood cell DNA extractionGSTP1 and TNFa polymorphisms with PCR | Diagnostic test | Cases, Controls |
| Urinary testingUrinary nicotine and cotinine detection | Diagnostic test | Cases, Controls |
Primary outcome
GSTP1 and TNFa variants in children with asthma
Time frame: 0 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children and Wheezing, run by AHEPA University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GSTP1 and TNFa variants in children with asthma (time frame: 0 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.