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Smoking Cessation in Patients With COPD (SMOCC) in General Practice

Smoking Cessation in Patients With COPD (SMOCC) in General Practice

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00628225
Acronym
SMOCC
Enrollment
667
Registered
2008-03-04
Start date
2000-03-31
Completion date
2003-12-31
Last updated
2008-10-17

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Smoking cessation

Brief summary

Background: Smoking cessation is the key element in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these patients with successful quitting smoking was suboptimal. Therefore we evaluated the effectiveness of two smoking cessation programs (counseling and nicotine replacement) for smokers with COPD in routine general practice, one with (CNB) and one without (CN) the combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD symptoms in successful smoking cessation. Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The usual care group (UC) consisted of 148 patients (22 practices), the first intervention group (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second intervention group of 276 patients (25 practices. Main outcome measure was (biochemically verified) point prevalence.

Interventions

BEHAVIORALCounseling and Nicotine replacement (CN)

Professionals in general practice received a central training (4 hours) about smoking, smoking cessation and COPD. They received materials (leaflet, video, smoking cessation protocol and informationfolder). Moreover, professionals received a maximum of 4 practice visits from an outreach visitor. General practitioners were encouraged to advise nicotine replacement. Smoking COPD patients received smoking cessation counseling and were advised to use nicotine replacement.

BEHAVIORALCounseling, Nicotine replacement and Bupropion (CNB)

Professionals in general practice received a central training (4 hours) about smoking, smoking cessation and COPD. They received materials (leaflet, video, smoking cessation protocol and informationfolder). Moreover, professionals received a maximum of 4 practice visits from an outreach visitor. The general practitioner was encouraged to advice the patients to use both nicotine replacements and Bupropion-SR. Smoking COPD patients received smoking cessation counseling and were advised to use nicotine replacement and Bupropion-SR.

Sponsors

The Netherlands Asthma Foundation
CollaboratorOTHER
Pharmacia
CollaboratorINDUSTRY
GlaxoSmithKline
CollaboratorINDUSTRY
ZonMw: The Netherlands Organisation for Health Research and Development
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No

Inclusion criteria

A software program using Anatomical Therapeutical Chemical (ATC) prescription codes and International Classification of Primary Care (ICPC) diagnosis codes selected potential patients with COPD. Criteria: age \>35 years and a diagnosis recorded as COPD or as ICPC code R95/96, or a prescription of at least three times of bronchodilators (ATC code R03a/bc) and/or prescription of at least two times of inhaled anti-inflammatory medication in the past year (ATC code R03). General practitioners (GPs) had to confirm the diagnosis of the selection. Patients were eligible to participate if they met the following criteria: * Current smoking * Suffering from COPD according to the GP's diagnosis * In command of the Dutch language.

Exclusion criteria

* Too ill * Under control of a chest physician * Serious physical or psychological comorbidity

Design outcomes

Primary

MeasureTime frame
Smoking cessation (point prevalence, both self reported as biochemical verified)12 months

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026