Chronic Obstructive Pulmonary DiseasePhase 3SAVENCT01694732
Efficacy of Varenicline on Smoking Cessation at the Acute Phase of an Exacerbation of Chronic Obstructive Pulmonary Disease
A Phase 3 study testing Varenicline in people with Chronic Obstructive Pulmonary Disease and COPD Exacerbation, run by University Hospital, Brest at 13 sites in France.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the bronchi with an increasing prevalence. By 2020, the mortality related to COPD is expected to become the 3rd leading death worldwide. COPD is caused by smoking in approximately 90 % of the cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD Exacerbation, Smoking
- What is being tested?
- Varenicline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 13 sitesFrance
- Study dates
- Aug 2012to Nov 2015
- 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
- Patients smokers (= 10 cigarettes per day in the last year)
- Affected by a chronic obstructive pulmonary disease.
- Presenting a recent exacerbation having led to at least a 24-hour hospitalization in pneumology or intensive care unit.
- Motivated to quit smoking
- Able to understand the information and give a written consent.
- Available for a follow-up of 1 year.
Who cannot join
- Refusal or unable to consent.
- Unaffiliated or not entitled to the National Health Insurance Coverage.
- Absence of a chronic obstructive pulmonary disease according to the criteria ATS / ERS.
- presenting a contraindication to the pharmacotherapy (i.e. the active substance: tartrate of varénicline or one of the excipients)
- actively participating in other smoking cessation trials.
- Pregnancy: declared or planned in 14 months.
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- breastfeeding.
- Women old enough to procreate without reliable contraception.
- History of anorexia nervosa or bulimia.
- History of a severe depression and having required a medicinal treatment in 5 years.
- History of 2 or several episodes of severe depression and having required a medicinal treatment.
- Personal or family History of suicide attempt.
- History or current presence of dementia, a bipolar disease, a psychosis, a panic attack.
- Taken by psychotropic medicines in the inclusion excepted those prescribed to hypnotic aim and antidepressant medicine of the class of the inhibitors of the recapture of the sérotonine prescribed for a not severe depression
- Presence of a depression detected by means of the questionnaire HAD (not inclusion if the total of the sub-scale D is > 8 or if the total of scales A + D is > 16) and/or PHQ-9 (not inclusion if score > 9).
- SGOT or SGPT > 2 fold upper limit of normal, the hepatic cirrhosis, the acute hepatitis.
- Renal insufficiency (clearance of the creatinine < 30 ml / min according to the formula of Cockcroft).
- Excessive consumption of alcohol (more than 21 glasses a week for the men, more than 14 glasses of wines a week to them Women).
- Use of marijuana or other forms of tobacco during the study.
- Use of other stimulant drugs (ephedrine, phenylephrine) or appetite suppressants during the study.
- Life expectancy of ≤ 12-months (ex: patients affected by a chronic disease in terminal phase).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CHU Angers
Angers, France, 49933
Hôpital HIA Clermont Tonnerre
Brest, France, 29200
Cavale Blanche Hospital
Brest, France, 29609
CHRU Lille
Lille, 59037
Laennec Hospital
Nantes, France, 44093
Caremeau Hospital
Nîmes, France, 30029
Hotel Dieu Hospital
Paris, France, 75004
HEGP Hospital
Paris, France, 75015
Poitiers Hospital
Poitiers, France, 86021
Cornouaille Hospital
Quimper, France, 29107
Pontchaillou
Rennes, France, 35033
Saint Brieuc Hospital
Saint-Brieuc, France, 22027
Bretonneau Hospital
Tours, France, 37044
About this study
Official title: Efficacy of Varenicline Associated With Intensive Counselling Versus Placebo of Varenicline Associated With Intensive Counselling on Smoking Cessation at the Acute Phase of an Exacerbation of Chronic Obstructive Pulmonary Disease (COPD). A Multicenter Randomized Double-blind Trial
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the bronchi with an increasing prevalence. By 2020, the mortality related to COPD is expected to become the 3rd leading death worldwide. COPD is caused by smoking in approximately 90 % of the cases. Nevertheless, COPD remains under-diagnosed and more than half of patients remain active smokers. Brittany is the second region of France facing an abnormal high death rate related to COPD. Smoking cessation is the most effective therapeutic approach to reduce the evolution of the disease, the frequency of the exacerbations and the the mortality. Besides, smoking cessation is associated with a reduced risk of cardiovascular events and cancer. Given the COPD patients' strong addiction, smoking cessation is not easily obtained in such population. Furthermore, smoking cessation has been underestimated in several studies. Most of these studies evaluated various methods of smoking cessation in COPD patients performed after an exacerbation, which has a hospitalization related mortality of approximately 10%. Thus, there is an urgent need to find effective pharmacotherapies to help COPD patients to cease smoking. Varenicline, a partial agonist at a4ß2 nicotinic acetylcholine receptors is reported to be one of the most effective pharmacotherapies for smoking cessation. However, it has never been evaluated at the acute phase of an exacerbation of COPD requiring hospitalization.
- Being tested
- Varenicline, placebo
- Keywords
- Chronic obstructive pulmonary disease, Varenicline, Smoking cessation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| varenicline with counselling | Experimental | Active varenicline associated with intensive smoking cessation counselling Receives: Drug: Varenicline |
| Placebo with counselling | Placebo comparator | Placebo of varenicline associated with intensive smoking cessation counselling Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate an increase in smoking abstinence rate
To demonstrate that in smokers with COPD hospitalized for an exacerbation early initiation of a pharmacotherapy by varenicline during 12 weeks is associated with a higher rate of long-term smoking abstinence measured in 1 year compared to placebo.
Measured: 12 months
Secondary outcomes (1)
Estimate the tolerance of the varenicline
Evaluate the side effects of varenicline after 3 months of treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis COUTURAUD, Pr, Principal investigator, University hospital of Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694732
- Sponsor's protocol ID
- SAVE RB11-135
- Other IDs
- RB 11-135
- Acronym
- SAVE
- Status last verified
- Feb 2016
- First submitted
- 24 Sep 2012
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
PubMed 34611902Le Mao R, Tromeur C, Paleiron N, Sanchez O, Gagnadoux F, Jouneau S, Magnan A, Hayem-Vannimenus C, Dansou A, Proust A, Dion A, Larhantec G, Brestec AL, Dewitte JD, Roche N, Leroyer C, Couturaud F. Effect of Early Initiation of Varenicline on Smoking Cessation in COPD Patients Admitted for Exacerbation: The Save Randomized Clinical Trial. COPD. 2020 Feb;17(1):7-14. doi: 10.1080/15412555.2019.1703928. Epub 2019 Dec 19.
PubMed 31854207
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Varenicline Associated With Intensive Counselling Versus Placebo of Varenicline Associated With Intensive Counselling on Smoking Cessation at the Acute Phase of an Exacerbation of Chronic Obstructive Pulmonary Disease (COPD). A Multicenter Randomized Double-blind Trial
- ClinicalTrials.gov ID
- NCT01694732
- Acronym / sponsor ID
- SAVE / SAVE RB11-135
- Keywords
- Chronic obstructive pulmonary disease, Varenicline, Smoking cessation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Sep 2012 (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.
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the bronchi with an increasing prevalence. By 2020, the mortality related to COPD is expected to become the 3rd leading death worldwide. COPD is caused by smoking in approximately 90 % of the cases. Nevertheless, COPD remains under-diagnosed and more than half of patients remain active smokers. Brittany is the second region of France facing an abnormal high death rate related to COPD. Smoking cessation is the most effective therapeutic approach to reduce the evolution of the disease, the frequency of the exacerbations and the the mortality. Besides, smoking cessation is associated with a reduced risk of cardiovascular events and cancer. Given the COPD patients' strong addiction, smoking cessation is not easily obtained in such population. Furthermore, smoking cessation has been underestimated in several studies. Most of these studies evaluated various methods of smoking cessation in COPD patients performed after an exacerbation, which has a hospitalization related mortality of approximately 10%. Thus, there is an urgent need to find effective pharmacotherapies to help COPD patients to cease smoking. Varenicline, a partial agonist at a4ß2 nicotinic acetylcholine receptors is reported to be one of the most effective pharmacotherapies for smoking cessation. However, it has never been evaluated at the acute phase of an exacerbation of COPD requiring hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| varenicline with counselling | Experimental | Drug: VareniclineActive varenicline associated with intensive smoking cessation counselling |
| Placebo with counselling | Placebo comparator | Drug: placeboPlacebo of varenicline associated with intensive smoking cessation counselling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients smokers (= 10 cigarettes per day in the last year)
- Affected by a chronic obstructive pulmonary disease.
- Presenting a recent exacerbation having led to at least a 24-hour hospitalization in pneumology or intensive care unit.
- Motivated to quit smoking
- Able to understand the information and give a written consent.
Key exclusion criteria (21 listed)
- Refusal or unable to consent.
- Unaffiliated or not entitled to the National Health Insurance Coverage.
- Absence of a chronic obstructive pulmonary disease according to the criteria ATS / ERS.
- presenting a contraindication to the pharmacotherapy (i.e. the active substance: tartrate of varénicline or one of the excipients)
- actively participating in other smoking cessation trials.
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 |
|---|---|---|
| Varenicline | Drug | varenicline with counselling |
| placebo | Drug | Placebo with counselling |
Primary outcome
To demonstrate an increase in smoking abstinence rate
Time frame: 12 months
To demonstrate that in smokers with COPD hospitalized for an exacerbation early initiation of a pharmacotherapy by varenicline during 12 weeks is associated with a higher rate of long-term smoking abstinence measured in 1 year compared to placebo.
1 secondary outcome
Estimate the tolerance of the varenicline
Time frame: 3 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 11 Feb 2016.
- Derived from this study: PubMed 34611902Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
- Derived from this study: PubMed 31854207Le Mao R, Tromeur C, Paleiron N, Sanchez O, Gagnadoux F, Jouneau S, Magnan A, Hayem-Vannimenus C, Dansou A, Proust A, Dion A, Larhantec G, Brestec AL, Dewitte JD, Roche N, Leroyer C, Couturaud F. Effect of Early Initiation of Varenicline on Smoking Cessation in COPD Patients Admitted for Exacerbation: The Save Randomized Clinical Trial. COPD. 2020 Feb;17(1):7-14. doi: 10.1080/15412555.2019.1703928. Epub 2019 Dec 19.
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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.
Francis COUTURAUD, Pr principal investigator
University hospital of Brest
13 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 Varenicline in people with Chronic Obstructive Pulmonary Disease and COPD Exacerbation, run by University Hospital, Brest at 13 sites in France.
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 6 inclusion and 21 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 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. 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. Some participants in this study may receive a placebo. 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 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?
To demonstrate an increase in smoking abstinence rate (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 NCT01694732, which also lists 2 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 11 Feb 2016.