The efficacy and cost-effectiveness of confrontational counselling for smoking cessation in smokers with previously undiagnosed COPD: a randomised controlled trial
- Conditions
- Tobacco addiction, chronic obstructive pulmonary disease (COPD)RespiratoryChronic obstructive pulmonary disease (COPD)
- Registration Number
- ISRCTN64481813
- Lead Sponsor
- niversity Maastricht (UM), CAPHRI Research Institute (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 350
1. Age between 35 through 70 years
2. Smoker with a smoking history of >10 pack years of cigarettes
3. Motivated to stop smoking
4. One or more of the following symptoms are present: cough, progressive persistent shortness of breath (worse during exercise or respiratory infections) or sputum production
5. Bronchus obstruction detected by spirometry: FEV1/FVC-ratio <70% and postbronchodilatory FEV1 >50% predicted (= mild or moderate COPD/GOLD I or II)
6. Competent enough in speaking the Dutch language
1. Known by the general practitioner or in the second-line medical care with the diagnosis asthma or COPD (e.g. chronic bronchitis, lung emphysema)
2. Spirometry performed during the preceding 12 months
3. FEV1 <50% predicted (= severe or very severe COPD/GOLD III or IV)
4. Contraindications for the intake of the medication such as an acute myocardial infarction and hypersensitiveness for nortriptyline
5. Current use of antidepressants
6. Quit smoking attempt(s) using nortriptyline or bupropion during the preceding 6 months
7. Co-morbidity: hypersensitiveness towards nortriptyline, tuberculosis, porfyrine, epilepsy, Parkinson's disease, glaucoma, bronchial carcinoma or any other live threatening disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method