Chronic Obstructive Pulmonary Disease (COPD)Phase 4SMOCCNCT00628225
Smoking Cessation in Patients With COPD (SMOCC) in General Practice
A Phase 4 study testing Counseling and Nicotine replacement (CN) and Counseling, Nicotine replacement and Bupropion (CNB) in people with Chronic Obstructive Pulmonary Disease (COPD), run by ZonMw: The Netherlands Organisation for Health Research and Development at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Counseling and Nicotine replacement (CN) and Counseling, Nicotine replacement and Bupropion (CNB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 667 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2000to Dec 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Too ill
- Under control of a chest physician
- Serious physical or psychological comorbidity
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500HB
About this study
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.
- Being tested
- Counseling and Nicotine replacement (CN), Counseling, Nicotine replacement and Bupropion (CNB)
- Keywords
- Smoking cessation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling and Nicotine replacement (CN)Behavioural
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)Behavioural
Also called Bupropion-SR (Zyban)
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Usual Care |
| 2 | Experimental | Multifacetted smoking cessation intervention (aimed at professional (training and education) and at patients (counseling + nicotine replacement) Receives: Behavioral: Counseling and Nicotine replacement (CN) |
| 3 | Experimental | Multifacetted smoking cessation intervention (aimed at professional (training and education) and at patients (counseling + nicotine replacement + bupropion-SR) Receives: Behavioral: Counseling, Nicotine replacement and Bupropion (CNB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation (point prevalence, both self reported as biochemical verified)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2008 (estimated)
- Study startMar 2000
- Primary completionDec 2002
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZonMw: The Netherlands Organisation for Health Research and Development
- Sponsor type
- University, hospital or other
- Collaborators
- The Netherlands Asthma Foundation, Pharmacia, GlaxoSmithKline
- Investigators
- Annelies E Jacobs, PHD, Study chair, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628225
- Sponsor's protocol ID
- zonmw22000039
- Other IDs
- GlaxoSmithKline ZYB40023, Pharmacia HK/jh/00013, Dutch Asthma Found. 3.4.98.47
- Acronym
- SMOCC
- Status last verified
- Feb 2008
- First submitted
- 25 Feb 2008
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16157462Hilberink 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.
PubMed 16203030Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
PubMed 37230961Hilberink 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.
PubMed 20430565
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation in Patients With COPD (SMOCC) in General Practice
- ClinicalTrials.gov ID
- NCT00628225
- Acronym / sponsor ID
- SMOCC / zonmw22000039
- Keywords
- Smoking cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- ZonMw: The Netherlands Organisation for Health Research and DevelopmentUniversity, hospital or other
- Collaborators
- The Netherlands Asthma Foundation, Pharmacia, GlaxoSmithKline
- Study start
- Mar 2000
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 4 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Usual Care |
| 2 | Experimental | Behavioral: Counseling and Nicotine replacement (CN)Multifacetted smoking cessation intervention (aimed at professional (training and education) and at patients (counseling + nicotine replacement) |
| 3 | Experimental | Behavioral: Counseling, Nicotine replacement and Bupropion (CNB)Multifacetted smoking cessation intervention (aimed at professional (training and education) and at patients (counseling + nicotine replacement + bupropion-SR) |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Too ill
- Under control of a chest physician
- Serious physical or psychological comorbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | 2 |
| Counseling, Nicotine replacement and Bupropion (CNB)Also: Bupropion-SR (Zyban)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. | Behavioural | 3 |
Primary outcome
Smoking cessation (point prevalence, both self reported as biochemical verified)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2008.
- Results publication: PubMed 16157462Hilberink 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.
- Results publication: PubMed 16203030Hilberink 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.
- Derived from this study: PubMed 37230961Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
- Derived from this study: PubMed 20430565Hilberink 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annelies E Jacobs, PHD study chair
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Counseling and Nicotine replacement (CN) and Counseling, Nicotine replacement and Bupropion (CNB) in people with Chronic Obstructive Pulmonary Disease (COPD), run by ZonMw: The Netherlands Organisation for Health Research and Development at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation (point prevalence, both self reported as biochemical verified) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00628225, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2008.