NCT00628225

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
667

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2000

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2008

Completed
Last Updated

October 17, 2008

Status Verified

February 1, 2008

Enrollment Period

2.8 years

First QC Date

February 25, 2008

Last Update Submit

October 16, 2008

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Smoking cessation

Outcome Measures

Primary Outcomes (1)

  • Smoking cessation (point prevalence, both self reported as biochemical verified)

    12 months

Study Arms (3)

1

NO INTERVENTION

Usual Care

2

EXPERIMENTAL

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

Behavioral: Counseling and Nicotine replacement (CN)

3

EXPERIMENTAL

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)

Interventions

Counseling and Nicotine replacement (CN)BEHAVIORAL

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.

2
Counseling, Nicotine replacement and Bupropion (CNB)BEHAVIORAL

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.

Also known as: Bupropion-SR (Zyban)
3

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Too ill
  • Under control of a chest physician
  • Serious physical or psychological comorbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500HB, Netherlands

Location

Related Publications (4)

  • Hilberink SR, Jacobs JE, Schlosser M, Grol RP, de Vries H. Characteristics of patients with COPD in three motivational stages related to smoking cessation. Patient Educ Couns. 2006 Jun;61(3):449-57. doi: 10.1016/j.pec.2005.05.012. Epub 2005 Sep 12.

    PMID: 16157462RESULT

  • Hilberink SR, Jacobs JE, Bottema BJ, de Vries H, Grol RP. Smoking cessation in patients with COPD in daily general practice (SMOCC): six months' results. Prev Med. 2005 Nov-Dec;41(5-6):822-7. doi: 10.1016/j.ypmed.2005.08.003. Epub 2005 Oct 3.

    PMID: 16203030RESULT

  • Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

    PMID: 37230961DERIVED

  • Hilberink SR, Jacobs JE, Breteler MH, de Vries H, Grol RP. General practice counseling for patients with chronic obstructive pulmonary disease to quit smoking: impact after 1 year of two complex interventions. Patient Educ Couns. 2011 Apr;83(1):120-4. doi: 10.1016/j.pec.2010.04.009. Epub 2010 Apr 28.

    PMID: 20430565DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveSmoking Cessation

Interventions

CounselingNicotine Replacement TherapyBupropion

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDrug TherapyTherapeuticsPropiophenonesKetonesOrganic Chemicals

Study Officials

  • Annelies E Jacobs, PHD

    Radboud University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 4, 2008

Study Start

March 1, 2000

Primary Completion

December 1, 2002

Study Completion

December 1, 2003

Last Updated

October 17, 2008

Record last verified: 2008-02

Locations

NL(1)