<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01694732</url>
  </required_header>
  <id_info>
    <org_study_id>SAVE RB11-135</org_study_id>
    <secondary_id>RB 11-135</secondary_id>
    <nct_id>NCT01694732</nct_id>
  </id_info>
  <brief_title>Efficacy of Varenicline on Smoking Cessation at the Acute Phase of an Exacerbation of Chronic Obstructive Pulmonary Disease</brief_title>
  <acronym>SAVE</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the bronchi&#xD;
      with an increasing prevalence. By 2020, the mortality related to COPD is expected to become&#xD;
      the 3rd leading death worldwide. COPD is caused by smoking in approximately 90 % of the&#xD;
      cases. Nevertheless, COPD remains under-diagnosed and more than half of patients remain&#xD;
      active smokers. Brittany is the second region of France facing an abnormal high death rate&#xD;
      related to COPD. Smoking cessation is the most effective therapeutic approach to reduce the&#xD;
      evolution of the disease, the frequency of the exacerbations and the the mortality. Besides,&#xD;
      smoking cessation is associated with a reduced risk of cardiovascular events and cancer.&#xD;
      Given the COPD patients' strong addiction, smoking cessation is not easily obtained in such&#xD;
      population. Furthermore, smoking cessation has been underestimated in several studies. Most&#xD;
      of these studies evaluated various methods of smoking cessation in COPD patients performed&#xD;
      after an exacerbation, which has a hospitalization related mortality of approximately 10%.&#xD;
      Thus, there is an urgent need to find effective pharmacotherapies to help COPD patients to&#xD;
      cease smoking. Varenicline, a partial agonist at a4ß2 nicotinic acetylcholine receptors is&#xD;
      reported to be one of the most effective pharmacotherapies for smoking cessation. However, it&#xD;
      has never been evaluated at the acute phase of an exacerbation of COPD requiring&#xD;
      hospitalization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To demonstrate an increase in smoking abstinence rate</measure>
    <time_frame>12 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimate the tolerance of the varenicline</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluate the side effects of varenicline after 3 months of treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>COPD Exacerbation</condition>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>varenicline with counselling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active varenicline associated with intensive smoking cessation counselling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo with counselling</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo of varenicline associated with intensive smoking cessation counselling</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Varenicline</intervention_name>
    <arm_group_label>varenicline with counselling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Placebo with counselling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients smokers (= 10 cigarettes per day in the last year)&#xD;
&#xD;
          -  Affected by a chronic obstructive pulmonary disease.&#xD;
&#xD;
          -  Presenting a recent exacerbation having led to at least a 24-hour hospitalization in&#xD;
             pneumology or intensive care unit.&#xD;
&#xD;
          -  Inclusion during hospitalization.&#xD;
&#xD;
          -  Motivated to quit smoking&#xD;
&#xD;
          -  Able to understand the information and give a written consent.&#xD;
&#xD;
          -  Available for a follow-up of 1 year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal or unable to consent.&#xD;
&#xD;
          -  Unaffiliated or not entitled to the National Health Insurance Coverage.&#xD;
&#xD;
          -  Absence of a chronic obstructive pulmonary disease according to the criteria ATS /&#xD;
             ERS.&#xD;
&#xD;
          -  presenting a contraindication to the pharmacotherapy (i.e. the active substance:&#xD;
             tartrate of varénicline or one of the excipients)&#xD;
&#xD;
          -  actively participating in other smoking cessation trials.&#xD;
&#xD;
          -  Pregnancy: declared or planned in 14 months.&#xD;
&#xD;
          -  breastfeeding.&#xD;
&#xD;
          -  Women old enough to procreate without reliable contraception.&#xD;
&#xD;
          -  History of anorexia nervosa or bulimia.&#xD;
&#xD;
          -  History of a severe depression and having required a medicinal treatment in 5 years.&#xD;
&#xD;
          -  History of 2 or several episodes of severe depression and having required a medicinal&#xD;
             treatment.&#xD;
&#xD;
          -  Personal or family History of suicide attempt.&#xD;
&#xD;
          -  History or current presence of dementia, a bipolar disease, a psychosis, a panic&#xD;
             attack.&#xD;
&#xD;
          -  Taken by psychotropic medicines in the inclusion excepted those prescribed to hypnotic&#xD;
             aim and antidepressant medicine of the class of the inhibitors of the recapture of the&#xD;
             sérotonine prescribed for a not severe depression&#xD;
&#xD;
          -  Presence of a depression detected by means of the questionnaire HAD (not inclusion if&#xD;
             the total of the sub-scale D is &gt; 8 or if the total of scales A + D is &gt; 16) and/or&#xD;
             PHQ-9 (not inclusion if score &gt; 9).&#xD;
&#xD;
          -  SGOT or SGPT &gt; 2 fold upper limit of normal, the hepatic cirrhosis, the acute&#xD;
             hepatitis.&#xD;
&#xD;
          -  Renal insufficiency (clearance of the creatinine &lt; 30 ml / min according to the&#xD;
             formula of Cockcroft).&#xD;
&#xD;
          -  Excessive consumption of alcohol (more than 21 glasses a week for the men, more than&#xD;
             14 glasses of wines a week to them Women).&#xD;
&#xD;
          -  Use of marijuana or other forms of tobacco during the study.&#xD;
&#xD;
          -  Use of other stimulant drugs (ephedrine, phenylephrine) or appetite suppressants&#xD;
             during the study.&#xD;
&#xD;
          -  Life expectancy of ≤ 12-months (ex: patients affected by a chronic disease in terminal&#xD;
             phase).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francis COUTURAUD, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University hospital of Brest</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital HIA Clermont Tonnerre</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cavale Blanche Hospital</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laennec Hospital</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Caremeau Hospital</name>
      <address>
        <city>Nimes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hotel Dieu Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HEGP Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poitiers Hospital</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cornouaille Hospital</name>
      <address>
        <city>Quimper</city>
        <zip>29107</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Brieuc Hospital</name>
      <address>
        <city>Saint Brieuc</city>
        <zip>22027</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bretonneau Hospital</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>February 10, 2016</last_update_submitted>
  <last_update_submitted_qc>February 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic obstructive pulmonary disease</keyword>
  <keyword>Varenicline</keyword>
  <keyword>Smoking cessation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varenicline</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01694732
org study id: SAVE RB11-135
secondary id: RB 11-135
nct id: NCT01694732
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: To demonstrate an increase in smoking abstinence rate
time frame: 12 months
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.
measure: Estimate the tolerance of the varenicline
time frame: 3 months
description: Evaluate the side effects of varenicline after 3 months of treatment
arm group label: varenicline with counselling
arm group type: Experimental
description: Active varenicline associated with intensive smoking cessation counselling
arm group label: Placebo with counselling
arm group type: Placebo Comparator
description: Placebo of varenicline associated with intensive smoking cessation counselling
intervention type: Drug
intervention name: Varenicline
arm group label: varenicline with counselling
intervention type: Drug
intervention name: placebo
arm group label: Placebo with counselling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Francis COUTURAUD, Pr
role: Principal Investigator
affiliation: University hospital of Brest
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Varenicline