Smoking Cessation Clinical Trial
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. aged at 40-75 years old; 2. FEV1/FVC>70% after inhaled bronchodilator 3. current smoker (= 10 pack-years) 4. rate of FEV1 decline >30ml/y 5. lived in a community for more than 1 years and has no plans to move out in the next 4 years Exclusion Criteria: 1. 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; 2. history of lobectomy and / or lung transplantation; 3. predicted life expectancy less than 3 years; 4. history of severe psychiatric illnesses, mental disorders, neurological disorders, malignant tumors, chronic liver disease, heart failure, autoimmune diseases, chronic kidney disease; 5. Alcoholism, drug abuse or abuse of toxic solvents; 6. Cannot finish long term follow-up or poor compliance; 7. Do not provide consent |
Country | Name | City | State |
---|---|---|---|
China | Peking University First Hospital | Beijing | Beijing |
China | The Second Hospital of Jilin University | Ch'ang-ch'un | |
China | The Affiliated Hospital of Inner Mongolia Medical University | Hohhot | |
China | Shandong Provincial Hospital Affiliated to Shandong University | Jing'an | |
China | The First Hospital of Qinhuangdao | Qinhuangdao | |
China | The Second Hospital of Hebei Medical University | Shijia Zhuang | |
China | Shanxi Bethune Hospital | Taiyuan | |
China | Tianjin Medical University General Hospital | Tianjin | |
China | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | |
China | Henan Provincial People's Hospita | Zhenzhou |
Lead Sponsor | Collaborator |
---|---|
Peking University First Hospital | First Affiliated Hospital Xi'an Jiaotong University, Henan Provincial People's Hospital, Second Hospital of Jilin University, Shandong Provincial Hospital, Shanxi Bethune Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The First Hospital of Qinhuangdao, The Second Hospital of Hebei Medical University, Tianjin Medical University General Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | rate of quitting smoking | keep smoking cessation for more than 6 months | 1 year | |
Secondary | one month smoking cessation rate | stop smoking for more than one month, but less than six months | 6 months | |
Secondary | smoking reduction rate | less than the number of cigarettes before the first intervention | 1 year | |
Secondary | smoking cessation rate at each follow-up | stop smoking for 24 hours or more | 6 months | |
Secondary | relapse rate | relapse rate of smoking | 1 year |
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