<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/NCT02233231</url>
  </required_header>
  <id_info>
    <org_study_id>Young smoking asthmatics</org_study_id>
    <nct_id>NCT02233231</nct_id>
  </id_info>
  <brief_title>Smoking Young Asthmatics: Change of Inflammation During Tobacco Cessation and Steroid Treatment</brief_title>
  <official_title>Smoking Young Asthmatics: Change of Inflammation During Tobacco Cessation and Steroid Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vibeke Backer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bispebjerg Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study describing changes in inflammation of the airways in asthmatics before and&#xD;
      after smoking cessation and steroid treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      84 smoking asthmatics will be included. 50% will be treated with varenicline and 50% with&#xD;
      placebo tablets for 12 weeks. All will be treated with inhaled steroid for 12 weeks.&#xD;
&#xD;
      Study period: About 26 weeks including asthma screening. 4 visits will be performed.&#xD;
      Inflammation will be described through sputum induction, and several other pulmonary medical&#xD;
      tests will be performed, including NO, methacholine, spirometry, CO, blood samples, skin&#xD;
      prick test and asthma questionaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in sputum eosinophile-% from &gt;1% to normal or neutrophile-% from &gt;61% to normal, from baseline (week 0) to week 12.</measure>
    <time_frame>Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks)</time_frame>
    <description>Power calculations are based on changes during 0-12 weeks.&#xD;
The total study includes primary outcome measurements at:&#xD;
Visit 1: Week 0, Visit 2: Week 6, Visit 3: Week 12, Visit 4: Week 24</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in methacholine hyperresponsiveness by two dosis steps, from baseline (week 0) to week 12.</measure>
    <time_frame>Time frame for secondary outcome: 0-12 weeks</time_frame>
    <description>The secondary outcome are measured at:&#xD;
Visit 1: Week 0, Visit 2: Week 6, Visit 3: Week 12, Visit 4: Week 24</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Varenicline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Varenicline 0,5 mg x 1 day 1-3 Varenicline 0,5 mg x 2 day 4-6 Varenicline 2 mg x 1 day 7 to week 12</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo tablets equivalent to IMP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Varenicline</intervention_name>
    <description>Varenicline 2 mg x 1 day 7 to week 12</description>
    <arm_group_label>Varenicline</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>similar tabl</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Varenicline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Asthmatic symptoms during the last year and at least one criterion of the below:&#xD;
&#xD;
          1. current FEV1-increase of minimum 12% after b2-agonist,&#xD;
&#xD;
          2. positiv Methacholintest,&#xD;
&#xD;
          3. Day-to-day FEV1-variation of at least 20% during a two-week period.&#xD;
&#xD;
          4. Positive mannitol test.&#xD;
&#xD;
        Furthermore, all of the below inclusion criteria:&#xD;
&#xD;
          -  At least 10 packyears&#xD;
&#xD;
          -  At least 10 cigarettes per day within the last year&#xD;
&#xD;
          -  Age 18-40 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Asthmatics who have been treated with inhaled corticosteroids (ICS), systemic&#xD;
             corticosteroids, leukotrien-antagonists (LTA), long-lasting b2-agonists,&#xD;
             anticholinergic medicine or varenicline within the last 3 months&#xD;
&#xD;
          2. Lower respiratory tract infections, including pneumonia, within the last 6 weeks.&#xD;
&#xD;
          3. Patients suffering from other chronic respiratory disease than asthma, such as&#xD;
             sarcoidosis and COPD will also be excluded.&#xD;
&#xD;
          4. Pregnant and nursing women will be excluded as well as women planning pregnancy during&#xD;
             the study period.&#xD;
&#xD;
          5. A history of allergy towards study drugs will lead to exclusion.&#xD;
&#xD;
        Patients who during the study period develop lower respiratory infections or due to severe&#xD;
        uncontrolled asthma receive treatment with any of the above listed types of medicine will&#xD;
        be excluded. Patients who are diagnosed with other chronic respiratory disease than asthma&#xD;
        during the study period will also be excluded, as well as patients who during the study&#xD;
        period require more asthma medicine than the planned study medication.&#xD;
&#xD;
        Any participant who wishes to leave the study, for any reason, including unacceptable&#xD;
        side-effects, during the study period will be excluded, as well as anyone who wants to&#xD;
        withdraw their recorded data from the project after the study period has ended.&#xD;
&#xD;
        In case of unacceptable side-effects to varenicline resulting in immediate cessation of&#xD;
        treatment with this drug, the participant will continue visits unchanged, but he/she will&#xD;
        be excluded from the calculations of tobacco cessation succes-rate. However, varenicline&#xD;
        cessation up to 4 weeks after treatment start with varenicline will result in exclusion and&#xD;
        replacement of the participant.&#xD;
&#xD;
        Cessation of treatment with budesonide will result in exclusion from the rest the study.&#xD;
        The person will not be replaced. The data recorded from the participant until the last&#xD;
        visit before cessation will be used.&#xD;
&#xD;
        Allergic reactions towards study drugs will result in immediate cessation of the drug, and&#xD;
        possible exclusion, as described in the above.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>March 18, 2013</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>January 31, 2020</last_update_submitted>
  <last_update_submitted_qc>January 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Vibeke Backer</investigator_full_name>
    <investigator_title>MD, DMSCI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</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/NCT02233231
org study id: Young smoking asthmatics
nct id: NCT02233231
lead sponsor: 
has dmc: Yes
This is a study describing changes in inflammation of the airways in asthmatics before and
      after smoking cessation and steroid treatment.
84 smoking asthmatics will be included. 50% will be treated with varenicline and 50% with
      placebo tablets for 12 weeks. All will be treated with inhaled steroid for 12 weeks.

      Study period: About 26 weeks including asthma screening. 4 visits will be performed.
      Inflammation will be described through sputum induction, and several other pulmonary medical
      tests will be performed, including NO, methacholine, spirometry, CO, blood samples, skin
      prick test and asthma questionaires.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12.
time frame: Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks)
description: Power calculations are based on changes during 0-12 weeks.
The total study includes primary outcome measurements at:
Visit 1: Week 0, Visit 2: Week 6, Visit 3: Week 12, Visit 4: Week 24
measure: Change in methacholine hyperresponsiveness by two dosis steps, from baseline (week 0) to week 12.
time frame: Time frame for secondary outcome: 0-12 weeks
description: The secondary outcome are measured at:
Visit 1: Week 0, Visit 2: Week 6, Visit 3: Week 12, Visit 4: Week 24
arm group label: Varenicline
arm group type: Active Comparator
description: Varenicline 0,5 mg x 1 day 1-3 Varenicline 0,5 mg x 2 day 4-6 Varenicline 2 mg x 1 day 7 to week 12
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo tablets equivalent to IMP.
intervention type: Drug
intervention name: Varenicline
description: Varenicline 2 mg x 1 day 7 to week 12
arm group label: Varenicline
other name: Placebo
intervention type: Drug
intervention name: Placebo
description: similar tabl
arm group label: Placebo
other name: Varenicline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Vibeke Backer
investigator title: MD, DMSCI
mesh term: Inflammation
mesh term: Varenicline