AsthmaNCT00341653
A Cohort Study of Smoking Prevention and Health Promotion for Middle School Students in Wuhan, China
An observational study of Asthma, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in China.
Trial summary
We propose to add a collection of buccal cells to a school-based cohort of 7th graders in Wuhan, a large industrial city in China. The cohort study is being conducted by the Wuhan Public Health and Anti-Epidemic Station (Li Yan MD, director and principal investigator). Read more about this study
- Who is it for?
- Ages 12 to 13 years
- Conditions the study is for
- Asthma
- How many people
- 5,051 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 1998to 16 May 2019
- 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 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 7th grade students enrolled at the Wuhan Public Health and Anti-Epidemic Station.
- Consent signed by parent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
We propose to add a collection of buccal cells to a school-based cohort of 7th graders in Wuhan, a large industrial city in China. The cohort study is being conducted by the Wuhan Public Health and Anti-Epidemic Station (Li Yan MD, director and principal investigator). The cohort study is designed to look at several outcomes. One is initiation of smoking. The second is respiratory health in relation to active and passive smoking and other environmental exposures that are prevalent in Wuhan. The respiratory outcomes include changes in pulmonary function, asthma and other respiratory symptoms. Collection of buccal cells is a noninvasive method of obtaining DNA. The addition of a genetic sample will enable us to examine candidate gene associations for asthma and childhood respiratory illness within an interesting and well-characterized Chinese population. In addition, it provides the capability to examine gene environment interaction with respect to common environmental exposures in Wuhan. The ability to examine gene-environment interaction can help to identify relatively subtle effects of pollutants such as environmental tobacco smoke which is becoming a very common exposure due to the major increase in smoking among Chinese men. Other exposures of interest in Wuhan are indoor coal burning and high ambient exposures to particules, ozone and nitrogen oxides. The proposed study has been approved by the human subjects committee of the Wuhan Public Health and Anti-Epidemic Station....
Read the detailed description
We propose to add a collection of buccal cells to a school-based cohort of 7th graders in Wuhan, a large industrial city in China. The cohort study is being conducted by the Wuhan Public Health and Anti-Epidemic Station (Li Yan MD, director and principal investigator). The cohort study is designed to look at several outcomes. One is initiation of smoking. The second is respiratory health in relation to active and passive smoking and other environmental exposures that are prevalent in Wuhan. The respiratory outcomes include changes in pulmonary function, asthma and other respiratory symptoms. Collection of buccal cells is a noninvasive method of obtaining DNA. The addition of a genetic sample will enable us to examine candidate gene associations for asthma and childhood respiratory illness within an interesting and well-characterized Chinese population. In addition, it provides the capability to examine gene environment interaction with respect to common environmental exposures in Wuhan. The ability to examine gene-environment interaction can help to identify relatively subtle effects of pollutants such as environmental tobacco smoke which is becoming a very common exposure due to the major increase in smoking among Chinese men. Other exposures of interest in Wuhan are indoor coal burning and high ambient exposures to particules, ozone and nitrogen oxides. The proposed study has been approved by the human subjects committee of the Wuhan Public Health and Anti-Epidemic Station.
- Conditions
- Asthma
- Keywords
- Asthma, Pulmonary Function, Air Pollution, Genetic Polymorphism, Environmental Tobacco Agents
- Medical subject headings
- Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start1 Dec 1998
- Study completion16 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 5,051 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stephanie London, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341653
- Sponsor's protocol ID
- 999998054
- Other IDs
- OH98-E-N054
- Status last verified
- 16 May 2019
- First submitted
- 19 Jun 2006
- Last updated
- 23 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Smoking Prevention and Health Promotion for Middle School Students in Wuhan, China
- ClinicalTrials.gov ID
- NCT00341653
- Acronym / sponsor ID
- 999998054
- Conditions
- Asthma
- Keywords
- Asthma, Pulmonary Function, Air Pollution, Genetic Polymorphism, Environmental Tobacco Agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,051 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 1 Dec 1998
- Study completion
- 16 May 2019
- First posted
- 21 Jun 2006 (estimated)
- 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.
We propose to add a collection of buccal cells to a school-based cohort of 7th graders in Wuhan, a large industrial city in China. The cohort study is being conducted by the Wuhan Public Health and Anti-Epidemic Station (Li Yan MD, director and principal investigator). The cohort study is designed to look at several outcomes. One is initiation of smoking. The second is respiratory health in relation to active and passive smoking and other environmental exposures that are prevalent in Wuhan. The respiratory outcomes include changes in pulmonary function, asthma and other respiratory symptoms. Collection of buccal cells is a noninvasive method of obtaining DNA. The addition of a genetic sample will enable us to examine candidate gene associations for asthma and childhood respiratory illness within an interesting and well-characterized Chinese population. In addition, it provides the capability to examine gene environment interaction with respect to common environmental exposures in Wuhan. The ability to examine gene-environment interaction can help to identify relatively subtle effects of pollutants such as environmental tobacco smoke which is becoming a very common exposure due to the major increase in smoking among Chinese men. Other exposures of interest in Wuhan are indoor coal burning and high ambient exposures to particules, ozone and nitrogen oxides. The proposed study has been approved by the human subjects committee of the Wuhan Public Health and Anti-Epidemic Station....
Detailed description
We propose to add a collection of buccal cells to a school-based cohort of 7th graders in Wuhan, a large industrial city in China. The cohort study is being conducted by the Wuhan Public Health and Anti-Epidemic Station (Li Yan MD, director and principal investigator). The cohort study is designed to look at several outcomes. One is initiation of smoking. The second is respiratory health in relation to active and passive smoking and other environmental exposures that are prevalent in Wuhan. The respiratory outcomes include changes in pulmonary function, asthma and other respiratory symptoms. Collection of buccal cells is a noninvasive method of obtaining DNA. The addition of a genetic sample will enable us to examine candidate gene associations for asthma and childhood respiratory illness within an interesting and well-characterized Chinese population. In addition, it provides the capability to examine gene environment interaction with respect to common environmental exposures in Wuhan. The ability to examine gene-environment interaction can help to identify relatively subtle effects of pollutants such as environmental tobacco smoke which is becoming a very common exposure due to the major increase in smoking among Chinese men. Other exposures of interest in Wuhan are indoor coal burning and high ambient exposures to particules, ozone and nitrogen oxides. The proposed study has been approved by the human subjects committee of the Wuhan Public Health and Anti-Epidemic Station.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 7th grade students enrolled at the Wuhan Public Health and Anti-Epidemic Station.
- Consent signed by parent.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 23 Sep 2019.
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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.
Stephanie London, M.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in China.
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 2 inclusion and 0 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 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 23 Sep 2019.