Condition category
Respiratory
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
03/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J. van der Palen

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Netherlands Asthma Foundation (Netherlands)

Sponsor details

Speelkamp 28
Leusden
3831 PE
Netherlands

Sponsor type

Charity

Website

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

  1. 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.

Additional files

Editorial Notes