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

This study has been completed.
Sponsor:
Collaborators:
The Netherlands Asthma Foundation
Pharmacia
GlaxoSmithKline
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00628225
First received: February 25, 2008
Last updated: October 16, 2008
Last verified: February 2008

February 25, 2008
October 16, 2008
March 2000
December 2002   (final data collection date for primary outcome measure)
Smoking cessation (point prevalence, both self reported as biochemical verified) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00628225 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Smoking Cessation in Patients With COPD (SMOCC) in General Practice
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease (COPD)
  • Behavioral: Counseling 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.

  • Behavioral: Counseling, 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.

    Other Name: Bupropion-SR (Zyban)
  • No Intervention: 1
    Usual Care
  • Experimental: 2
    Multifacetted smoking cessation intervention (aimed at professional (training and education) and at patients (counseling + nicotine replacement)
    Intervention: Behavioral: Counseling and Nicotine replacement (CN)
  • Experimental: 3
    Multifacetted smoking cessation intervention (aimed at professional (training and education) and at patients (counseling + nicotine replacement + bupropion-SR)
    Intervention: Behavioral: Counseling, Nicotine replacement and Bupropion (CNB)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
667
December 2003
December 2002   (final data collection date for primary outcome measure)

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
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00628225
zonmw22000039, GlaxoSmithKline ZYB40023, Pharmacia HK/jh/00013, Dutch Asthma Found. 3.4.98.47
Yes
Dr. A. Jacobs, Radboud University Nijmegen Medical Centre
ZonMw: The Netherlands Organisation for Health Research and Development
  • The Netherlands Asthma Foundation
  • Pharmacia
  • GlaxoSmithKline
Study Chair: Annelies E Jacobs, PHD Radboud University
Radboud University
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP