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| Sponsor: | ZonMw: The Netherlands Organisation for Health Research and Development |
|---|---|
| Collaborators: |
Dutch Asthma Foundation Pharmacia GlaxoSmithKline |
| Information provided by: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT00628225 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment |
| Official Title: | Smoking Cessation in Patients With COPD (SMOCC) in General Practice |
| 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 |
|---|---|
|
1: No Intervention
Usual Care
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2: Experimental
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. |
|
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)
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. |
Eligibility| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | 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:
Exclusion Criteria:
Contacts and Locations| Netherlands | |
| Radboud University Nijmegen Medical Centre | |
| Nijmegen, Netherlands, 6500HB | |
| Study Chair: | Annelies E Jacobs, PHD | Radboud University |
More Information
| Responsible Party: | Radboud University Nijmegen Medical Centre ( Dr. A. Jacobs ) |
| 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 |
| ClinicalTrials.gov Identifier: | NCT00628225 History of Changes |
| Health Authority: | The Netherlands: Maastricht University |
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Smoking cessation |
|
Nicotine polacrilex Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Cholinergic Agonists Molecular Mechanisms of Pharmacological Action Nicotinic Agonists Physiological Effects of Drugs Psychotropic Drugs Cholinergic Agents Lung Diseases, Obstructive Respiratory Tract Diseases Nicotine |
Therapeutic Uses Ganglionic Stimulants Antidepressive Agents, Second-Generation Antidepressive Agents Central Nervous System Stimulants Pharmacologic Actions Autonomic Agents Lung Diseases Bupropion Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents Pulmonary Disease, Chronic Obstructive |
