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

Z

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

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)

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems