SMOKE study: evaluation of the effectiveness of an intensive SmokeStopTherapy in an outpatient clinic setting for patients with chronic obstructive pulmonary disease

INTERVENTION: 1. Control group: minimal intervention strategy for lung patients (LMIS) ‐ the LMIS consists of individual counselling and telephone contacts which could be combined with pharmacological support at the patients? own expense 2. Experimental group: SmokeStopTherapy (SST) ‐ the SST consists of both individual and group counselling, telephone contacts and bupropion free of charge. Additionally, patients can re‐enter the individual sessions after they experienced a lapse within three months after the start of the intervention (?recycling?) to prevent a total relapse. Other sponsor's for this trial are: 1. Medisch Spectrum Twente, P.O. Box 50000, 7500 KA, Enschede, The Netherlands 2. Slotervaart Hospital, P.O. Box 90440, 1006 BK, Amsterdam, The Netherlands 3. Catharina Hospital, P.O. Box 1350, 5602 ZA, Eindhoven, The Netherlands CONDITION: Chronic obstructive pulmonary disease (COPD) ; Respiratory ; Other chronic obstructive pulmonary disease PRIMARY OUTCOME: 1. Biochemically validated (salivary cotinine) continuous abstinence rate (defined as validated abstinence at six months and twelve months after the start of the intervention); 2. Biochemically validated point prevalence abstinence rate at 12 months after the start of SmokeStopTherapy (point prevalence) SECONDARY OUTCOME: 1. Quality of life, measured by the St. Georges's Respiratory Questionnaire; 2. Lung function (FEV1, inspired vital capacity [IVC], FEV1/IVC, FEV1% predicted); 3. The frequency and severity of exacerbations. The following severity‐scale will be used:; 3.1. Mild exacerbation: increased use of pulmonary medication by more than two occasions within a 24 hour period on three or more consecutive days, compared to the stable situation; 3.2. Moderately severe exacerbation: ; 3.2.1. Treatment with antibiotics and/or oral steroids; 3.2.2. Evidence of a chest infection; 3.2.3. An increase in symptoms and increased use of pulmonary medication by more than four occasions within a 24 hour period on three or more consecutive days, compared to the stable situation; 3.3. Severe exacerbation: requirement of emergency hospital treatment/hospital admission; 4. Disease‐specific symptoms: breathlessness, coughing, sputum production and sputum colour. Symptom scores will be used to indicate the severity of the symptoms; 5. Additional secondary data for economic evaluation (cost‐effectiveness):; 5.1. Number of visits at the outpatient clinic; 5.2. Number of hospital‐admissions and admission‐days; 5.3. Number of visits to the emergency room; 5.4. Days lost of work; 5.5. Medication costs (from pharmacy records); 5.6. Euroqol 5D INCLUSION CRITERIA: 1. Outpatients of Medisch Spectrum Twente (Enschede), Slotervaart hospital (Amsterdam), or Catharina hospital (Eindhoven) 2. Current smoker 3. Motivated to quit smoking 4. Aged 40 ‐ 75 years (1961‐1826) 5. Clinically treated COPD. Moderate COPD (% predicted forced expiratory volume in one second [FEV1] = 50 ‐ 69) or severe COPD (% predicted FEV1 less than or equal to 50 as defined by the American Thoracic Society (ATS) criteria