Chronic Obstructive Pulmonary Disease COPD Lung emphysema and chronic bronchitis Smoking Tobacco addiction Nicotine dependence Smoking cessation Smoking reduction
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. COPD, GOLD stage I-IV; 2. Age 40-80 years; 3. Smoking 10 or more cigarettes daily; 4. Motivated to reduce smoking; 5. 2 failed lifetime quit attempts (abstinence > 24 hours)
Exclusion criteria
Exclusion criteria: 1. Motivated to quit smoking within 1 month from baseline (= ready to quit); 2. Not able to speak, read and write Dutch; 3. Contra-indication for the use of NRT; 4. Serious psychiatric morbidity (not only depressive symptoms); 5. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter is the percentage of patients with continuous cotinine-validated abstinence after two years from baseline, for at least the last full year. Continuous abstinence is defined as having salivary cotinine levels < 20ng/mL at measurements at 12 and 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Smoking reduction / decrease of the daily cigarette consumption; 2. Behavioural prognostic determinants of smoking reduction and cessation (e.g. attitude, self-efficacy, nicotine dependence); 3. Point prevalence abstinence rates at 12, 18, and 24 months; 4. Disease-specific QoL; 5. Lung function (FEV1, IVC, FEV1/IVC, FEV1% predicted); 6. Frequency and severity of exacerbations; 7. Disease-specific symptoms (breathlessness, coughing, sputum production); 8. Motivation/readiness to quit smoking; 9. Cost-effectiveness data. | — |
Contacts
University of Twente, building citadel, P.O.Box 217