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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— SMOCC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628225
• Other study ID #: zonmw22000039
• Secondary ID: GlaxoSmithKline
• Status: Completed
• Phase: Phase 4
• First received: February 25, 2008
• Last updated: October 16, 2008
• Start date: March 2000
• Est. completion date: December 2003

Study information

• Verified date: February 2008
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: Maastricht University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 667
• Est. completion date: December 2003
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (4)

Lead Sponsor	Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development	GlaxoSmithKline, Pharmacia, The Netherlands Asthma Foundation

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. Epub 2005 Oct 3. — View Citation

Hilberink SR, Jacobs JE, Schlösser 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. Epub 2005 Sep 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking cessation (point prevalence, both self reported as biochemical verified)		12 months	No