Clinical trial NCT00628225: Smoking Cessation in Patients With COPD (SMOCC) in General Practice
Official title: Smoking Cessation in Patients With COPD (SMOCC) in General Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Smoking cessation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: The Netherlands Asthma Foundation
name: Pharmacia
name: GlaxoSmithKline
First posted: 2008-03-04
Enrollment: 667
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Smoking cessation (point prevalence, both self reported as biochemical verified)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Annelies E Jacobs, PHD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.