The efficacy and cost-effectiveness of confrontational counselling for smoking cessation in smokers with previously undiagnosed COPD: a randomised controlled trial.
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- 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 (c.q. 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 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 The primary outcome of this study is biochemically validated prolonged abstinence from smoking during a period of 12 months. A smoker is defined as prolonged abstinent if he/she is a non-smoker (no cigarette smoked during the preceding seven days), at the end of the intervention (day 50), and at the follow-up-visits after 6 months (day 197) and 12 months (day 380. Non-smoking is verified by urine cotinine. Participants with a cotinine-value of > 50ng/mL are regarded as smokers as well as participants who are lost to follow-up.
- Secondary Outcome Measures
Name Time Method