<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/NCT02264145</url>
  </required_header>
  <id_info>
    <org_study_id>260.3171</org_study_id>
    <nct_id>NCT02264145</nct_id>
  </id_info>
  <brief_title>The Effect of Alcoholic-carrier Solutions Within Devices (HFA134a-MDI or Respimat®) on Breath Alcohol Measured by Ethylometer in Healthy Volunteers</brief_title>
  <official_title>The Effect of Alcoholic-carrier Solutions Within-devices (HFA134a-MDI or Respimat®) on Breath Alcohol Measured by Ethylometer in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The study objective is to determine the effect of the ethanolic solutions inhaled from the&#xD;
      Metered dose inhaler (MDI) (15.5 mg, 31.2 mg and 62.4 mg of ethanol) and from Respimat® (18.4&#xD;
      of ethanol) on the breath alcohol measurements in healthy volunteers.&#xD;
&#xD;
      Secondary aim is to determine the linear dose-effect for the HFA 134a-MDI doses. An open,&#xD;
      randomized, four-way-cross-over design is chosen. The randomization is balanced and&#xD;
      stratified in accordance with predicted values of the volunteers of Total Lung Capacity (TLC)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 1998</start_date>
  <primary_completion_date type="Actual">December 1998</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under curve (AUC) of blood alcohol level estimated from breath alcohol concentration after the four formulation inhalations</measure>
    <time_frame>up to 15 min after inhalation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Breath alcohol concentration profile within each formulation</measure>
    <time_frame>up to 15 min after inhalation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum duration of alcohol detection exhaled air (Td) for each formulation</measure>
    <time_frame>up to 15 min after inhalation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Highest breath alcohol concentration measured (Cmax)</measure>
    <time_frame>up to 15 min after inhalation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to highest breath concentration (Tmax)</measure>
    <time_frame>up to 15 min after inhalation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 5 days</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Ethanolic Solution From HFA134a-MDI - low</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ethanolic Solution From HFA134a-MDI - medium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ethanolic Solution From HFA134a-MDI - high</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ethanolic Solution From Respimat®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ethanolic Solution From HFA134a-MDI - low</intervention_name>
    <arm_group_label>Ethanolic Solution From HFA134a-MDI - low</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ethanolic Solution From HFA134a-MDI - medium</intervention_name>
    <arm_group_label>Ethanolic Solution From HFA134a-MDI - medium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ethanolic Solution From HFA134a-MDI - high</intervention_name>
    <arm_group_label>Ethanolic Solution From HFA134a-MDI - high</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ethanolic Solution From Respimat®</intervention_name>
    <arm_group_label>Ethanolic Solution From Respimat®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy non-smoker volunteers without dental prothesis&#xD;
&#xD;
          -  18 to 45 years old, male or female&#xD;
&#xD;
          -  No clinically significant abnormal conditions at the screening visit. A clinically&#xD;
             significant disease is defined as one, which in the opinion of the investigator, may&#xD;
             either put the subject at risk because of participation in the study, or a disease&#xD;
             which may influence the results of the study or the subjects ability to participate in&#xD;
             the study&#xD;
&#xD;
          -  Volunteer with gamma-glutamyl-transferase (GGT) level &lt; 32 IU/L&#xD;
&#xD;
          -  Volunteer is able to sign informed consent in accordance with Good Clinical Practice&#xD;
             and local legislation&#xD;
&#xD;
          -  Volunteers is able to be trained in the performance of technically satisfactory&#xD;
             pulmonary function tests&#xD;
&#xD;
          -  Volunteer is able to be trained in the correct use HFA-MDI, Respimat® and Ethylometer&#xD;
&#xD;
          -  Affiliated to the National Social Security System&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are already taking other investigational drugs or who have taken part in&#xD;
             another trial during the past month&#xD;
&#xD;
          -  Consumption of alcoholic beverage within 12 hours prior to observation period&#xD;
&#xD;
          -  Breast feeding or pregnant female or female with no medically approved contraception&#xD;
             method (oral contraceptive, intra uterine device)&#xD;
&#xD;
          -  Subjects who have a known intolerance or hypersensitivity to aerosolized containing&#xD;
             products and/or to any of the HFA-MDI or Respimat® excipient&#xD;
&#xD;
          -  Volunteer with history of drug abuse and/or alcoholism&#xD;
&#xD;
          -  Intensive exercise one week prior to the study&#xD;
&#xD;
          -  Major exposure to dust, smoke or pollution one week prior to the study&#xD;
&#xD;
          -  Subjects with an upper or lower respiratory tract infection within the previous four&#xD;
             weeks to screening. This is to insure no reduced alcohol absorption by mucus&#xD;
&#xD;
          -  Current psychiatric disorders&#xD;
&#xD;
          -  Previous inclusion in the randomized period of this study&#xD;
&#xD;
          -  Subjects on concomitant medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 14, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 14, 2014</last_update_submitted>
  <last_update_submitted_qc>October 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Norflurane</mesh_term>
    <mesh_term>Pharmaceutical Solutions</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/NCT02264145
org study id: 260.3171
nct id: NCT02264145
lead sponsor: 
The study objective is to determine the effect of the ethanolic solutions inhaled from the
      Metered dose inhaler (MDI) (15.5 mg, 31.2 mg and 62.4 mg of ethanol) and from Respimat® (18.4
      of ethanol) on the breath alcohol measurements in healthy volunteers.

      Secondary aim is to determine the linear dose-effect for the HFA 134a-MDI doses. An open,
      randomized, four-way-cross-over design is chosen. The randomization is balanced and
      stratified in accordance with predicted values of the volunteers of Total Lung Capacity (TLC)
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double
measure: Area under curve (AUC) of blood alcohol level estimated from breath alcohol concentration after the four formulation inhalations
time frame: up to 15 min after inhalation
measure: Breath alcohol concentration profile within each formulation
time frame: up to 15 min after inhalation
measure: Maximum duration of alcohol detection exhaled air (Td) for each formulation
time frame: up to 15 min after inhalation
measure: Highest breath alcohol concentration measured (Cmax)
time frame: up to 15 min after inhalation
measure: Time to highest breath concentration (Tmax)
time frame: up to 15 min after inhalation
measure: Number of patients with adverse events
time frame: up to 5 days
arm group label: Ethanolic Solution From HFA134a-MDI - low
arm group type: Experimental
arm group label: Ethanolic Solution From HFA134a-MDI - medium
arm group type: Experimental
arm group label: Ethanolic Solution From HFA134a-MDI - high
arm group type: Experimental
arm group label: Ethanolic Solution From Respimat®
arm group type: Experimental
intervention type: Drug
intervention name: Ethanolic Solution From HFA134a-MDI - low
arm group label: Ethanolic Solution From HFA134a-MDI - low
intervention type: Drug
intervention name: Ethanolic Solution From HFA134a-MDI - medium
arm group label: Ethanolic Solution From HFA134a-MDI - medium
intervention type: Drug
intervention name: Ethanolic Solution From HFA134a-MDI - high
arm group label: Ethanolic Solution From HFA134a-MDI - high
intervention type: Drug
intervention name: Ethanolic Solution From Respimat®
arm group label: Ethanolic Solution From Respimat®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Norflurane
mesh term: Pharmaceutical Solutions