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

ZonMw: The Netherlands Organisation for Health Research and Development

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Behavioral: Counseling and Nicotine replacement (CN); Behavioral: Counseling, Nicotine replacement and Bupropion (CNB)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00628225

GlaxoSmithKline ZYB40023

zonmw22000039

Dutch Asthma Found. 3.4.98.47

Pharmacia HK/jh/00013

Details and patient eligibility

About

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.

Enrollment: 667 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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667 participants in 3 patient groups

1

No Intervention group

Description:

Usual Care

2

Experimental group

Description:

Multifacetted smoking cessation intervention (aimed at professional (training and education) and at patients (counseling + nicotine replacement)

Treatment:

Behavioral: Counseling and Nicotine replacement (CN)

3

Experimental group

Description:

Multifacetted smoking cessation intervention (aimed at professional (training and education) and at patients (counseling + nicotine replacement + bupropion-SR)

Treatment:

Behavioral: Counseling, Nicotine replacement and Bupropion (CNB)