Smoking Cessation in Patients With COPD (SMOCC) in General Practice - Tabular View

Tracking Information

First Received Date ^ICMJE

February 25, 2008

Last Updated Date

October 16, 2008

Start Date ^ICMJE

March 2000

Primary Completion Date

December 2002 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00628225 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Subject), Parallel Assignment

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease (COPD)

Intervention ^ICMJE

Behavioral: Counseling and Nicotine replacement (CN)
Behavioral: Counseling, Nicotine replacement and Bupropion (CNB)

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

667

Completion Date

December 2003

Primary Completion Date

December 2002 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

35 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00628225

Responsible Party

Dr. A. Jacobs, Radboud University Nijmegen Medical Centre

Study ID Numbers ^ICMJE

zonmw22000039, GlaxoSmithKline ZYB40023, Pharmacia HK/jh/00013, Dutch Asthma Found. 3.4.98.47

Study Sponsor ^ICMJE

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborators ^ICMJE

Dutch Asthma Foundation
Pharmacia
GlaxoSmithKline

Investigators ^ICMJE

Study Chair:

Annelies E Jacobs, PHD

Radboud University

Information Provided By

Radboud University

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP