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

ISRCTN	ISRCTN43240264
DOI	https://doi.org/10.1186/ISRCTN43240264
Protocol serial number	NTR103; Dutch Asthma Foundation: 3.4.01.67.
Sponsor	Netherlands Asthma Foundation (Netherlands)
Funders	Comprehensive Cancer Centre (Netherlands), GlaxoSmithKline (Netherlands), Stedendriehoek Twente (IKST) (Netherlands), Netherlands Asthma Foundation (Netherlands)

Submission date: 12/09/2005
Registration date: 12/09/2005
Last edited: 03/07/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J. van der Palen
Scientific

Research Coordinator
Medisch Spectrum Twente
P.O. Box 50000
Enschede
7500 KA
Netherlands

Study information

Primary study design	Interventional
Study design	Multicentre, randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	1. The SmokeStopTherapy (SST) is twice as effective than the minimal intervention strategy for lung patients (LMIS) 12 months after the start of the intervention based on validated continuous abstinence rates in patients with chronic obstructive pulmonary disease (COPD) 2. After one year the SST is more cost-effective than the LMIS 3. The secondary aim was to investigate the prospective determinants of smoking cessation in patients with COPD within the two separate smoking cessation programmes. Based on the ASE model, it was expected that Attitude, Social Support and Self-efficacy would be important predictors within both interventions.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Chronic obstructive pulmonary disease (COPD)
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
Intervention type	Other
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	234
Key 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
Key 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
Date of first enrolment	15/02/2002
Date of final enrolment	31/12/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Research Coordinator

Enschede
7500 KA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2007		Yes	No