Smoking CessationNCT04996329
Early Health Warning Intervention in Tobacco Control
A study testing early health warning intervention in people with Smoking Cessation, run by Peking University First Hospital at 10 sites in China.
Trial summary
This is a multi-center, randomized, controlled intervention clinical trial. A total of 1000 current smokers with rapid decline in lung function will be recruited and equally divided into two groups, comprehensive smoking cessation intervention group (early health warning intervention combined with brief smoking… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- early health warning intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 10 sitesChina
- Study dates
- 21 Apr 2021to 31 Dec 2022
- Phase
- Interventional
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged at 40-75 years old;
- FEV1/FVC>70% after inhaled bronchodilator
- current smoker (≥ 10 pack-years)
- rate of FEV1 decline >30ml/y
- lived in a community for more than 1 years and has no plans to move out in the next 4 years
Who cannot join
- history of asthma, COPD, lung cancer, active pulmonary tuberculosis, bronchiectasis, diffuse lung disease (interstitial pneumonia, pulmonary sarcoidosis, occupational lung disease, sarcoidosis et al) and pleural disease;
- history of lobectomy and / or lung transplantation;
- predicted life expectancy less than 3 years;
- history of severe psychiatric illnesses, mental disorders, neurological disorders, malignant tumors, chronic liver disease, heart failure, autoimmune diseases, chronic kidney disease;
- Alcoholism, drug abuse or abuse of toxic solvents;
- Cannot finish long term follow-up or poor compliance;
- Do not provide consent
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality
Jiping Liao, MD, +86 13521714181, jipingliao@hotmail.com
- Not yet recruiting
The Second Hospital of Jilin University
Ch’ang-ch’un
Jinzhi Ying, MD, yjz6437@163.com
- Recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot
Xiuhua Fu, MD, fuxiuhua555@sohu.com
- Not yet recruiting
Shandong Provincial Hospital Affiliated to Shandong University
Jing’an
Jian Sun, MD, docbenjaminsun@163.com
- Recruiting
The First Hospital of Qinhuangdao
Qinhuangdao
Hua Qiao, MD, qh1202@163.com
- Recruiting
The Second Hospital of Hebei Medical University
Shijia Zhuang
Xixin Yan, MD, +86 15803210959, xi_xin_yan@163.com
- Recruiting
Shanxi Bethune Hospital
Taiyuan
Ruiying Wang, MD, +86 13903436432, wry0526@163.com
- Recruiting
Tianjin Medical University General Hospital
Tianjin
Lixia Dong, MD, luckydonglixia@163.com
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Xiaomin Dang, MD, dxming112@163.com
- Not yet recruiting
Henan Provincial People's Hospita
Zhenzhou
Limin Zhao, MD, zlm9898@126.com
About this study
Official title: A Comprehensive Tobacco Control With Early Health Warning Intervention in High Risk Population of COPD
This is a multi-center, randomized, controlled intervention clinical trial. A total of 1000 current smokers with rapid decline in lung function will be recruited and equally divided into two groups, comprehensive smoking cessation intervention group (early health warning intervention combined with brief smoking cessation intervention) and brief smoking cessation intervention group. It is aimed to evaluate whether early health warning intervention will increase the rate of smoking cessation.
Read the detailed description
This is a multi-center, randomized, controlled intervention clinical trial. A total of 1,000 current smokers ( ≥ 10 pack-years) with rapid decline in lung function will be recruited from Predictive Value of Inflammatory Biomarkers and FEV1 for COPD (PIFCOPD) study (clinical trails. gov ID NCT03532893) after 1 year of follow-up. Subjects will be qually divided into two groups, comprehensive smoking cessation intervention group (early health warning intervention combined with brief smoking cessation intervention) and brief smoking cessation intervention group. Health warning intervention is to tell the subjects that smoking leads to the rapid decline of their lung function, and they are at the high risk of developing COPD. The Department of Respiratory and Critical Care of Peking University First Hospital is responsible for this research. Other 9 units participating in the study, include the The Second Hospital of Hebei Medical University, Henan Provincial People's Hospital, The Second Hospital of Jilin University, The First Affiliated Hospital of Xi'an Jiaotong University, Shandong Provincial Hospital Affiliated to Shandong University, Shan xi Dayi Hospital（Shanxi Academy of Medical Sciences）, Tianjin Medical University General Hospital, The Affiliated Hospital of Inner Mongolia University. Some questionnaire about tobacco dependence, depression, anxiety, the willingness to quit smoking and withdrawal symptoms will be collected. Exhaled CO will be measured. Subjects will recived 6 times of smoking cessation intervention in 6 month and followed in another 6 month. The primary outcome is the rate of quitting smoking. The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2019-255). Any protocol modifications will be submitted for the IRB review and approval.
- Conditions
- Smoking Cessation
- Being tested
- early health warning intervention
- Keywords
- smoking cessation, brief smoking cessation intervention, current smokers, rapid decline in lung function
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early health warning interventionOther
early health warning intervention is to tell the subjects that smoking leads to the rapid decline of their lung function, and they are at the high risk of developing COPD.
| Study group | Role | What they receive |
|---|---|---|
| comprehensive smoking cessation intervention group | Experimental | Early health warning intervention combined with brief smoking cessation intervention Early health warning intervention is to tell the subjects that smoking leads to the rapid decline of their lung function, and they are at the high risk of developing COPD Receives: Other: early health warning intervention |
| brief smoking cessation intervention group | Active comparator | brief smoking cessation intervention only Receives: Other: early health warning intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of quitting smoking
keep smoking cessation for more than 6 months
Measured: 1 year
Secondary outcomes (4)
one month smoking cessation rate
stop smoking for more than one month, but less than six months
Measured: 6 months
smoking reduction rate
less than the number of cigarettes before the first intervention
Measured: 1 year
smoking cessation rate at each follow-up
stop smoking for 24 hours or more
Measured: 6 months
relapse rate
relapse rate of smoking
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start21 Apr 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University, Henan Provincial People's Hospital, Second Hospital of Jilin University, First Affiliated Hospital Xi'an Jiaotong University, Shandong Provincial Hospital, Shanxi Bethune Hospital, Tianjin Medical University General Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The First Hospital of Qinhuangdao
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996329
- Sponsor's protocol ID
- 2017YFC2019-255
- Status last verified
- Apr 2021
- First submitted
- 2 Aug 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Tobacco Control With Early Health Warning Intervention in High Risk Population of COPD
- ClinicalTrials.gov ID
- NCT04996329
- Acronym / sponsor ID
- 2017YFC2019-255
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, brief smoking cessation intervention, current smokers, rapid decline in lung function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University, Henan Provincial People's Hospital, Second Hospital of Jilin University, First Affiliated Hospital Xi'an Jiaotong University, Shandong Provincial Hospital, Shanxi Bethune Hospital, Tianjin Medical University General Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The First Hospital of Qinhuangdao
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Aug 2021 (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 is a multi-center, randomized, controlled intervention clinical trial. A total of 1000 current smokers with rapid decline in lung function will be recruited and equally divided into two groups, comprehensive smoking cessation intervention group (early health warning intervention combined with brief smoking cessation intervention) and brief smoking cessation intervention group. It is aimed to evaluate whether early health warning intervention will increase the rate of smoking cessation.
Detailed description
This is a multi-center, randomized, controlled intervention clinical trial. A total of 1,000 current smokers ( ≥ 10 pack-years) with rapid decline in lung function will be recruited from Predictive Value of Inflammatory Biomarkers and FEV1 for COPD (PIFCOPD) study (clinical trails. gov ID NCT03532893) after 1 year of follow-up. Subjects will be qually divided into two groups, comprehensive smoking cessation intervention group (early health warning intervention combined with brief smoking cessation intervention) and brief smoking cessation intervention group. Health warning intervention is to tell the subjects that smoking leads to the rapid decline of their lung function, and they are at the high risk of developing COPD. The Department of Respiratory and Critical Care of Peking University First Hospital is responsible for this research. Other 9 units participating in the study, include the The Second Hospital of Hebei Medical University, Henan Provincial People's Hospital, The Second Hospital of Jilin University, The First Affiliated Hospital of Xi'an Jiaotong University, Shandong Provincial Hospital Affiliated to Shandong University, Shan xi Dayi Hospital（Shanxi Academy of Medical Sciences）, Tianjin Medical University General Hospital, The Affiliated Hospital of Inner Mongolia University. Some questionnaire about tobacco dependence, depression, anxiety, the willingness to quit smoking and withdrawal symptoms will be collected. Exhaled CO will be measured. Subjects will recived 6 times of smoking cessation intervention in 6 month and followed in another 6 month. The primary outcome is the rate of quitting smoking. The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2019-255). Any protocol modifications will be submitted for the IRB review and approval.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| comprehensive smoking cessation intervention group | Experimental | Other: early health warning interventionEarly health warning intervention combined with brief smoking cessation intervention Early health warning intervention is to tell the subjects that smoking leads to the rapid decline of their lung function, and they are at the high risk of developing COPD |
| brief smoking cessation intervention group | Active comparator | Other: early health warning interventionbrief smoking cessation intervention only |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged at 40-75 years old;
- FEV1/FVC>70% after inhaled bronchodilator
- current smoker (≥ 10 pack-years)
- rate of FEV1 decline >30ml/y
- lived in a community for more than 1 years and has no plans to move out in the next 4 years
Key exclusion criteria (7 listed)
- history of asthma, COPD, lung cancer, active pulmonary tuberculosis, bronchiectasis, diffuse lung disease (interstitial pneumonia, pulmonary sarcoidosis, occupational lung disease, sarcoidosis et al) and pleural disease;
- history of lobectomy and / or lung transplantation;
- predicted life expectancy less than 3 years;
- history of severe psychiatric illnesses, mental disorders, neurological disorders, malignant tumors, chronic liver disease, heart failure, autoimmune diseases, chronic kidney disease;
- Alcoholism, drug abuse or abuse of toxic solvents;
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 |
|---|---|---|
| early health warning interventionearly health warning intervention is to tell the subjects that smoking leads to the rapid decline of their lung function, and they are at the high risk of developing COPD. | Other | brief smoking cessation intervention group, comprehensive smoking cessation intervention group |
Primary outcome
rate of quitting smoking
Time frame: 1 year
keep smoking cessation for more than 6 months
4 secondary outcomes
one month smoking cessation rate
Time frame: 6 months
smoking reduction rate
Time frame: 1 year
smoking cessation rate at each follow-up
Time frame: 6 months
relapse rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early health warning intervention in people with Smoking Cessation, run by Peking University First Hospital at 10 sites 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guangfa Wang, MD (+86 13810644029, wangguangfa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of quitting smoking (time frame: 1 year). 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 9 Aug 2021.