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
Secondary identifying numbers NTR103; Dutch Asthma Foundation: 3.4.01.67.
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

Study designMulticentre, randomised, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study objectives1. 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) studiedChronic obstructive pulmonary disease (COPD)
Intervention1. 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 typeOther
Primary outcome measure1. 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 measures1. 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
Overall study start date15/02/2002
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants234
Key inclusion criteria1. 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 criteria1. 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 enrolment15/02/2002
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Research Coordinator
Enschede
7500 KA
Netherlands

Sponsor information

Netherlands Asthma Foundation (Netherlands)
Charity

Speelkamp 28
Leusden
3831 PE
Netherlands

ROR logo "ROR" https://ror.org/04gmab760

Funders

Funder type

Industry

Comprehensive Cancer Centre (Netherlands)

No information available

GlaxoSmithKline (Netherlands)
Government organisation / For-profit companies (industry)
Alternative name(s)
GlaxoSmithKline plc., GSK plc., GSK
Location
United Kingdom
Stedendriehoek Twente (IKST) (Netherlands)

No information available

Netherlands Asthma Foundation (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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