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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
First received: September 24, 2012
Last updated: March 3, 2015
Last verified: March 2015

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
COPD Exacerbation
Drug: Varenicline
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • To demonstrate an increase in smoking abstinence rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Evaluate the side effects of varenicline after 3 months of treatment

Estimated Enrollment: 276
Study Start Date: August 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01694732

CHU Angers
Angers, France, 49933
Cavale Blanche Hospital
Brest, France, 29609
Hôpital HIA Clermont Tonnerre
Brest, France, 29200
CHRU Lille
Lille, France, 59037
Laennec Hospital
Nantes, France, 44093
Caremeau Hospital
Nimes, France, 30029
HEGP Hospital
Paris, France, 75015
Hotel Dieu Hospital
Paris, France, 75004
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
Principal Investigator: Francis COUTURAUD, Pr University hospital of Brest
  More Information

No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01694732     History of Changes
Other Study ID Numbers: SAVE RB11-135, RB 11-135
Study First Received: September 24, 2012
Last Updated: March 3, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Brest:
Chronic obstructive pulmonary disease
Smoking cessation

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 07, 2015