SmokingPhase 3NCT00132236
Nurse Smoking Cessation of Patients With Chronic Obstructive Pulmonary Disease (COPD) With Nicotine Replacement Therapy (NRT) and Behavioral Support
A Phase 3 study testing nicotine sublingual tablets and low and high behavior support in people with Smoking and COPD, run by University Hospital, Gentofte, Copenhagen at 7 sites in Denmark.
Trial summary
This is a smoking cessation study with COPD patients where the researchers wanted to evaluate if nicotine sublingual tablets or placebo combined with low or high individual support could increase ½ and 1 year quit rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- nicotine sublingual tablets and low and high behavior support
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 7 sitesDenmark
- Study dates
- Feb 2002to Jun 2004
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients (FEV1/FVC<70% and FEV1<90 % predicted)
- Smoking 1 cigarette daily or more
- Willing to follow the protocol
Who cannot join
- Used NRT or bupropion the last week
- Not able or willing to adhere to the protocol
- Estimated survival < 1 year
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Dept. pulm. medicine, Århus kommunehospital
Aarhus
Dept. pulm. medicine, Bispebjerg Hospital
Copenhagen
Dept of Pulm. medicine, Helsingør Sygehus
Elsinore
Pulm. Dept., Frederiksberg Hospital
Frederiksberg, Copenhagen
Pulm. Dept, Gentofte University Hospital
Hellerup, 2900
Dept. pulm. medicine, Nykøbing Falster Sygehus
Nykøbing Falster
Pulm. dept, Odense University Hospital
Odense
About this study
Official title: Smoking Cessation of Patients With COPD: A Multi-Center, Randomized, Placebo Controlled Nurse Conducted Smoking Cessation Trial
This is a smoking cessation study with COPD patients where the researchers wanted to evaluate if nicotine sublingual tablets or placebo combined with low or high individual support could increase ½ and 1 year quit rates.
Read the detailed description
Placebo, controlled, randomized, double-blind trial with 400-1000 smoking COPD patients with FEV-1 < 90 % predicted normal with the use of nicotine sublingual nicotine tablets or placebo for 12 weeks combined with individual clinic visits with low or high intensity conducted by trained nurses in several centres in pulmonary clinics in Denmark. Outcome was smoking cessation and smoking reduction after ½ and 1 year as self declared smoking status confirmed by carbon monoxide in expired air< 10 ppm. Secondary outcomes were change in body-weight, quality of life (SF-36 and SGRQ), symptoms, lung function, adverse events.
- Being tested
- nicotine sublingual tablets, low and high behavior support
- Keywords
- smoking cessation, nicotine sublingual tablets, behaviour support, smoking reduction, quality of life, COPD, weight
- Medical subject headings
- Smoking, Pulmonary Disease, Chronic Obstructive, Smoking Cessation, Smoking Reduction, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nicotine sublingual tabletsDrug
low and high behavior supportBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
smoking cessation after 6 and 12 months
Secondary outcomes (2)
smoking reduction after 12 months
change in quality of life (St. George Respiratory Questionnaire)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startFeb 2002
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Philip Tønnesen, M.D., Ph.D., Study chair, Pulm. dept. Gentofte University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132236
- Sponsor's protocol ID
- KA01096gms
- Other IDs
- CTN980-CHC-9015-027
- Status last verified
- Jul 2005
- First submitted
- 17 Aug 2005
- Last updated
- 21 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation of Patients With COPD: A Multi-Center, Randomized, Placebo Controlled Nurse Conducted Smoking Cessation Trial
- ClinicalTrials.gov ID
- NCT00132236
- Acronym / sponsor ID
- KA01096gms
- Keywords
- smoking cessation, nicotine sublingual tablets, behaviour support, smoking reduction, quality of life, COPD, weight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 300 participants
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Feb 2002
- Study completion
- Jun 2004
- First posted
- 19 Aug 2005 (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.
This is a smoking cessation study with COPD patients where the researchers wanted to evaluate if nicotine sublingual tablets or placebo combined with low or high individual support could increase ½ and 1 year quit rates.
Detailed description
Placebo, controlled, randomized, double-blind trial with 400-1000 smoking COPD patients with FEV-1 < 90 % predicted normal with the use of nicotine sublingual nicotine tablets or placebo for 12 weeks combined with individual clinic visits with low or high intensity conducted by trained nurses in several centres in pulmonary clinics in Denmark. Outcome was smoking cessation and smoking reduction after ½ and 1 year as self declared smoking status confirmed by carbon monoxide in expired air< 10 ppm. Secondary outcomes were change in body-weight, quality of life (SF-36 and SGRQ), symptoms, lung function, adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD patients (FEV1/FVC<70% and FEV1<90 % predicted)
- Smoking 1 cigarette daily or more
- Willing to follow the protocol
Key exclusion criteria (3 listed)
- Used NRT or bupropion the last week
- Not able or willing to adhere to the protocol
- Estimated survival < 1 year
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 |
|---|---|---|
| nicotine sublingual tablets | Drug | – |
| low and high behavior support | Behavioural | – |
Primary outcome
smoking cessation after 6 and 12 months
2 secondary outcomes
smoking reduction after 12 months
change in quality of life (St. George Respiratory Questionnaire)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2005.
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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.
Philip Tønnesen, M.D., Ph.D. study chair
Pulm. dept. Gentofte University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nicotine sublingual tablets and low and high behavior support in people with Smoking and COPD, run by University Hospital, Gentofte, Copenhagen at 7 sites in Denmark.
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 3 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: stopped early, as of the sponsor's last update on 21 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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 after 6 and 12 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2005.