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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01694732
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : February 11, 2016
Information provided by (Responsible Party):
University Hospital, Brest

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease COPD Exacerbation Smoking Drug: Varenicline Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2012
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: varenicline with counselling
Active varenicline associated with intensive smoking cessation counselling
Drug: Varenicline
Placebo Comparator: Placebo with counselling
Placebo of varenicline associated with intensive smoking cessation counselling
Drug: placebo

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Estimate the tolerance of the varenicline [ Time Frame: 3 months ]
    Evaluate the side effects of varenicline after 3 months of treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01694732

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CHU Angers
Angers, France, 49933
Hôpital HIA Clermont Tonnerre
Brest, France, 29200
Cavale Blanche Hospital
Brest, France, 29609
CHRU Lille
Lille, France, 59037
Laennec Hospital
Nantes, France, 44093
Caremeau Hospital
Nimes, France, 30029
Hotel Dieu Hospital
Paris, France, 75004
HEGP Hospital
Paris, France, 75015
Poitiers Hospital
Poitiers, France, 86021
Cornouaille Hospital
Quimper, France, 29107
Rennes, France, 35033
Saint Brieuc Hospital
Saint Brieuc, France, 22027
Bretonneau Hospital
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Brest
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Principal Investigator: Francis COUTURAUD, Pr University hospital of Brest
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Brest Identifier: NCT01694732    
Other Study ID Numbers: SAVE RB11-135
RB 11-135 ( Registry Identifier: RB 11-135 )
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016
Keywords provided by University Hospital, Brest:
Chronic obstructive pulmonary disease
Smoking cessation
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs