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Efficacy of Varenicline on Smoking Cessation at the Acute Phase of an Exacerbation of Chronic Obstructive Pulmonary Disease (SAVE)

Primary Purpose

Chronic Obstructive Pulmonary Disease, COPD Exacerbation, Smoking

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Varenicline
placebo
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic obstructive pulmonary disease, Varenicline, Smoking cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • Inclusion during hospitalization.
  • Motivated to quit smoking
  • Able to understand the information and give a written consent.
  • Available for a follow-up of 1 year.

Exclusion Criteria:

  • 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.
  • 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).

Sites / Locations

  • CHU Angers
  • Hôpital HIA Clermont Tonnerre
  • Cavale Blanche Hospital
  • CHRU Lille
  • Laennec Hospital
  • Caremeau Hospital
  • Hotel Dieu Hospital
  • HEGP Hospital
  • Poitiers Hospital
  • Cornouaille Hospital
  • Pontchaillou
  • Saint Brieuc Hospital
  • Bretonneau Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

varenicline with counselling

Placebo with counselling

Arm Description

Active varenicline associated with intensive smoking cessation counselling

Placebo of varenicline associated with intensive smoking cessation counselling

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Estimate the tolerance of the varenicline
Evaluate the side effects of varenicline after 3 months of treatment

Full Information

First Posted
September 24, 2012
Last Updated
February 10, 2016
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT01694732
Brief Title
Efficacy of Varenicline on Smoking Cessation at the Acute Phase of an Exacerbation of Chronic Obstructive Pulmonary Disease
Acronym
SAVE
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, COPD Exacerbation, Smoking
Keywords
Chronic obstructive pulmonary disease, Varenicline, Smoking cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
varenicline with counselling
Arm Type
Experimental
Arm Description
Active varenicline associated with intensive smoking cessation counselling
Arm Title
Placebo with counselling
Arm Type
Placebo Comparator
Arm Description
Placebo of varenicline associated with intensive smoking cessation counselling
Intervention Type
Drug
Intervention Name(s)
Varenicline
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
To demonstrate an increase in smoking abstinence rate
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Estimate the tolerance of the varenicline
Description
Evaluate the side effects of varenicline after 3 months of treatment
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Inclusion during hospitalization. Motivated to quit smoking Able to understand the information and give a written consent. Available for a follow-up of 1 year. Exclusion Criteria: 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. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis COUTURAUD, Pr
Organizational Affiliation
University hospital of Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Hôpital HIA Clermont Tonnerre
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Cavale Blanche Hospital
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Laennec Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Caremeau Hospital
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Hotel Dieu Hospital
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Name
HEGP Hospital
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Poitiers Hospital
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Cornouaille Hospital
City
Quimper
ZIP/Postal Code
29107
Country
France
Facility Name
Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Saint Brieuc Hospital
City
Saint Brieuc
ZIP/Postal Code
22027
Country
France
Facility Name
Bretonneau Hospital
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34611902
Citation
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.
Results Reference
derived
PubMed Identifier
31854207
Citation
Le 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.
Results Reference
derived

Learn more about this trial

Efficacy of Varenicline on Smoking Cessation at the Acute Phase of an Exacerbation of Chronic Obstructive Pulmonary Disease

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