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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Behavior Chronic Disease Disease Attributes Health Behavior Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Smoking Cessation

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500HB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling and Nicotine replacement (CN)

Behavioral

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.

Counseling, Nicotine replacement and Bupropion (CNB)

Behavioral

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.

Other names: Bupropion-SR (Zyban)

Primary outcomes

Smoking cessation (point prevalence, both self reported as biochemical verified)

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Other

Collaborators

GlaxoSmithKline
Pharmacia
The Netherlands Asthma Foundation

Registry information

Acronym: SMOCC

Important dates

Study start: 2000
Primary completion: 2002
Study completion: 2003
First posted: Mar 4, 2008
Registry last updated: Oct 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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