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
Scientific
Research Coordinator
Medisch Spectrum Twente
P.O. Box 50000
Enschede
7500 KA
Netherlands
Study information
| Study design | Multicentre, randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| 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 | 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 study start date | 15/02/2002 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
7500 KA
Netherlands
Sponsor information
Netherlands Asthma Foundation (Netherlands)
Charity
Charity
Speelkamp 28
Leusden
3831 PE
Netherlands
"ROR" |
https://ror.org/04gmab760 |
|---|
Funders
Funder type
Industry
Comprehensive Cancer Centre (Netherlands)
No information available
GlaxoSmithKline (Netherlands)
Government organisation / For-profit companies (industry)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
