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

Completed

Conditions: Chronic obstructive pulmonary disease (COPD)
Respiratory
Other chronic obstructive pulmonary disease

Registration Number: ISRCTN43240264

Lead Sponsor: etherlands Asthma Foundation (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 234

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

Exclusion Criteria

1. Hypersensitivity for elements of Bupropion SR
2. (Past history of) serious psychiatric co-morbidity
3. Liver cirrhosis/alcoholism
4. (Past history of) epilepsy/fits
5. Tumour in the central nervous system
6. Quitting the use of alcohol and/or benzodiazepines during the course of the study
7. (Past history of) diabetes
8. Eating disorder(s)
9. Usage of monoamine oxidase inhibitors (MAO-inhibitors)
10. A serious other disease with a low survival rate
11. Not able to understand, read or write Dutch
12. Women who are pregnant, breastfeeding or intending to conceive during the course of the study
13. Participant of the COPE study in the Medisch Spectrum Twente

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Biochemically validated (salivary cotinine) continuous abstinence rate (defined as validated abstinence at six months and twelve months after the start of the intervention)<br>2. Biochemically validated point prevalence abstinence rate at 12 months after the start of SmokeStopTherapy (point prevalence)

Secondary Outcome Measures