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
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Behavioral: Counseling and Nicotine replacement (CN)
Behavioral: Counseling, Nicotine replacement and Bupropion (CNB)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Smoking Cessation in Patients With COPD (SMOCC) in General Practice

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Smoking cessation (point prevalence, both self reported as biochemical verified) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 667
Study Start Date: March 2000
Study Completion Date: December 2003
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Usual Care
Experimental: 2
Multifacetted smoking cessation intervention (aimed at professional (training and education) and at patients (counseling + nicotine replacement)
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.

Experimental: 3
Multifacetted smoking cessation intervention (aimed at professional (training and education) and at patients (counseling + nicotine replacement + bupropion-SR)
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)

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00628225

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500HB
Sponsors and Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
The Netherlands Asthma Foundation
Pharmacia
GlaxoSmithKline
Investigators
Study Chair: Annelies E Jacobs, PHD Radboud University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. A. Jacobs, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00628225     History of Changes
Other Study ID Numbers: zonmw22000039, GlaxoSmithKline ZYB40023, Pharmacia HK/jh/00013, Dutch Asthma Found. 3.4.98.47
Study First Received: February 25, 2008
Last Updated: October 16, 2008
Health Authority: The Netherlands: Maastricht University

Keywords provided by Radboud University:
Smoking cessation

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Nicotine
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014