SMOKE study.

Evaluation of the effectiveness of an intensive SmokeStopTherapy in an outpatient clinic setting for patients with Chronic Obstructive Pulmonary Disease.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23457

Enrollment

234

Registered

2005-04-05

Start date

2002-02-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Minimal Intervention Strategy for Lung patients (LMIS) -> Control group SmokeStopTherapy (SST) -> Experimental group.

Eligibility

Inclusion criteria

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. 40-75 years (1961-1826); 5. Clinically treated COPD. Moderate COPD (% predicted FEV1=50-69) or severe COPD (% predicted FEV1=<50 as defined by the ATS criteria.

Exclusion criteria

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. Tumor 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.

Design outcomes

Primary

Measure	Time frame
Biochemically validated (salivary cotinine) continuous abstinence rate (defined as validated abstinence at six months and twelve months after the start of the intervention); biochemically validated point prevalence abstinence rate at 12 months after the start of SmokeStopTherapy (point prevalence).	—

Secondary

Measure	Time frame
1. Quality of life, measured by the St.Georges’s Respiratory Questionnaire; 2. Lung function (FEV1, IVC, FEV1/IVC, FEV1% predicted); 3. The frequency and severity of exacerbations. The following severity-scale will be used: 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. Moderately severe exacerbation: a. Treatment with antibiotics and/or oral steroids. b. Evidence of a chest infection. c. 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. 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): a. Number of visits at the outpatient clinic; b. Number of hospital-admissions and admission-days; c. Number of visits to the emergency room; d. Days lost of work; e. Medication costs (from pharmacy records); f. Euroqol 5D.	—

Measure

Time frame

1. Quality of life, measured by the St.Georges’s Respiratory Questionnaire; 2. Lung function (FEV1, IVC, FEV1/IVC, FEV1% predicted); 3. The frequency and severity of exacerbations. The following severity-scale will be used: 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. Moderately severe exacerbation: a. Treatment with antibiotics and/or oral steroids. b. Evidence of a chest infection. c. 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. 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): a. Number of visits at the outpatient clinic; b. Number of hospital-admissions and admission-days; c. Number of visits to the emergency room; d. Days lost of work; e. Medication costs (from pharmacy records); f. Euroqol 5D.

—

Contacts

Public ContactJ. Palen, van der

Medisch Spectrum Twente, P.O. Box 50000

+31 (0)53 4872023

Outcome results