Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR103; Dutch Asthma Foundation: 3.4.01.67.
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Multicentre, randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
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
Overall trial start date
15/02/2002
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
234
Participant 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
Recruitment start date
15/02/2002
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Research Coordinator
Enschede
7500 KA
Netherlands
Funders
Funder type
Industry
Funder name
Comprehensive Cancer Centre (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
GlaxoSmithKline (Netherlands)
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Funder name
Stedendriehoek Twente (IKST) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Netherlands Asthma Foundation (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17196359
Publication citations
-
Results
Christenhusz L, Pieterse M, Seydel E, van der Palen J, Prospective determinants of smoking cessation in COPD patients within a high intensity or a brief counseling intervention., Patient Educ Couns, 2007, 66, 2, 162-166, doi: 10.1016/j.pec.2006.11.006.