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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00628225
Recruitment Status : Completed
First Posted : March 4, 2008
Last Update Posted : October 17, 2008
Sponsor:
Collaborators:
The Netherlands Asthma Foundation
Pharmacia
GlaxoSmithKline
Information provided by:
Radboud University

Tracking Information
First Submitted Date  ICMJE February 25, 2008
First Posted Date  ICMJE March 4, 2008
Last Update Posted Date October 17, 2008
Study Start Date  ICMJE March 2000
Actual Primary Completion Date December 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2008)
Smoking cessation (point prevalence, both self reported as biochemical verified) [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Smoking Cessation in Patients With COPD (SMOCC) in General Practice
Official Title  ICMJE Smoking Cessation in Patients With COPD (SMOCC) in General Practice
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2008)
667
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2003
Actual Primary Completion Date December 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00628225
Other Study ID Numbers  ICMJE zonmw22000039
GlaxoSmithKline ZYB40023
Pharmacia HK/jh/00013
Dutch Asthma Found. 3.4.98.47
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. A. Jacobs, Radboud University Nijmegen Medical Centre
Study Sponsor  ICMJE ZonMw: The Netherlands Organisation for Health Research and Development
Collaborators  ICMJE
  • The Netherlands Asthma Foundation
  • Pharmacia
  • GlaxoSmithKline
Investigators  ICMJE
Study Chair: Annelies E Jacobs, PHD Radboud University
PRS Account Radboud University
Verification Date February 2008

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