Official Title: “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.

Results: Baseline analyses revealed the 22.5% was willing to quit smoking within 1 month, another 31.4% was willing to quit within six months. Greater motivation to quit smoking was positively associated with greater COPD symptom severity. After six months' follow-up more patients in the intervention group (CN: 16.0%, CNB: 13.3%) self-reported to have stopped smoking compared to patients receiving UC (8.8%) (bivariate comparison between UC-CN and UC-CNB yielded significant differences in these quit rates (p's<.05)). After twelve months these figures hardly changed (CN: 14.4%; CNB: 14.5%; UC: 7.4%). Biochemical verification (urine cotinine) of the self-reports dramatically lowered the quit rates (CN: 8.6%; CNB:

8.3%; UC: 4.1%). Thus, addition of bupropion-SR to the program did not increase the effectiveness of the intervention, therefore in subsequent analysis the two intervention groups were treated as one. The self-reported 12 months' quit rates were 7.4% in usual care versus 14.5% in the intervention (p<.05); after biochemical verification quit rates decreased to 4.1% and 8.5% respectively (p>.05). Less severe dyspnoea complaints and having had telephone counseling by the practice assistant predicted success.

Conclusion: A great part of smoking patients with COPD is willing to quit smoking withing six months. Patients suffering from more severe COPD symptoms had greater motivation than patients experiencing less burden from the disease. Application of the moderate intensive intervention in routine general practice doubled the quit rates but yielded small effects.

The program has potential to improve the treatment for patients with COPD and might be more successful if the quit attempt is supported by extra symptom medication. As the addition of bupropion-SR was only used by a minority its effectiveness in routine care could not be proven. Telephone follow-up counseling seems a useful support aid.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment

Study Primary Completion Date: December 2002

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: 1
  • Usual Care
• Experimental: 2
  • Multifacetted smoking cessation intervention (aimed at professional (training and education) and at patients (counseling + nicotine replacement)
• Experimental: 3
  • Multifacetted smoking cessation intervention (aimed at professional (training and education) and at patients (counseling + nicotine replacement + bupropion-SR)

Primary Measures

• Smoking cessation (point prevalence, both self reported as biochemical verified)
  • Time Frame: 12 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: ZonMw: The Netherlands Organisation for Health Research and Development

Overall Clinical Trial Officials and Contacts

Annelies E Jacobs, PHD Study Chair Radboud University  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00628225

Study ID Number: zonmw22000039

ClinicalTrials.gov Identifier: NCT00628225

Health Authority: The Netherlands: Maastricht University