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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Brest
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01694732
First received: September 24, 2012
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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
Smoking
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: September 2016
Estimated Primary Completion Date: September 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694732

Contacts
Contact: Francis COUTURAUD, Pr +33298347347 francis.couturaud@chu-brest.fr

Locations
France
CHU Angers Not yet recruiting
Angers, France, 49933
Contact: Frédéric GAGNADOUX, PU-PH         
Cavale Blanche Hospital Recruiting
Brest, France, 29609
Contact: Francis COUTURAUD, Pr         
Hôpital HIA Clermont Tonnerre Recruiting
Brest, France, 29200
Contact: Nicolas PALEIRON, MD         
Laennec Hospital Recruiting
Nantes, France, 44093
Contact: Antoine MAGNAN, Pr         
Caremeau Hospital Recruiting
Nimes, France, 30029
Contact: Alain PROUST, Dr         
HEGP Hospital Active, not recruiting
Paris, France, 75015
Hotel Dieu Hospital Not yet recruiting
Paris, France, 75004
Contact: Nicolas ROCHE, Pr         
Poitiers Hospital Active, not recruiting
Poitiers, France, 86021
Cornouaille Hospital Not yet recruiting
Quimper, France, 29107
Contact: Pierre JEZEQUEL, Dr         
Pontchaillou Recruiting
Rennes, France, 35033
Contact: Stephane JOUNEAU, Dr         
Saint Brieuc Hospital Not yet recruiting
Saint Brieuc, France, 22027
Contact: Myriam NIEL-DURIEZ, Dr         
Bretonneau Hospital Recruiting
Tours, France, 37044
Contact: Anne DANSOU, Dr         
Sponsors and Collaborators
University Hospital, Brest
Investigators
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: July 29, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Varenicline
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 30, 2014