<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/NCT02207426</url>
  </required_header>
  <id_info>
    <org_study_id>TobrAir - CT0040</org_study_id>
    <secondary_id>2013-005288-19</secondary_id>
    <nct_id>NCT02207426</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic and Pharmacoscintigraphic Comparison of TobrAir® 6.0 With TOBI® and TOBI® Podhaler™</brief_title>
  <official_title>A Phase 1 Study in Healthy Volunteers Investigating the Delivery of Tobramycin Using the TobrAir® 6.0 Device Compared With the Delivery of Marketed Tobramycin Nebuliser Solution (TOBI®) by PARI LC® PLUS and PARI TurboBoy® SX and With Delivery of Tobramycin by the TOBI® Podhaler™ Device, Using Pharmacokinetic and Pharmacoscintigraphic Methods.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pharmaero ApS</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pharmaero ApS</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares pharmacokinetic profiles of tobramycin delivered by TobrAir® 6.0 device&#xD;
      with TOBI® nebulizer system and the TOBI® Podhaler™ device. In addition, lung deposition of&#xD;
      tobramycin delivered by TobrAir® 6.0 device and by TOBI® nebulizer system will be determined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, randomized, single dose, cross-over study in healthy subjects. Each&#xD;
      subject receives tobramycin with 3 different inhalation devices:&#xD;
&#xD;
        -  75 mg tobramycin delivered to the airways via TobrAir® 6.0.&#xD;
&#xD;
        -  300 mg tobramycin (TOBI®) delivered to the airways via the PARI LC® PLUS/PARI TurboBoy®&#xD;
           SX.&#xD;
&#xD;
        -  112 mg tobramycin (4x28mg dry powder capsules) delivered to the airways via the TOBI®&#xD;
           Podhaler™.&#xD;
&#xD;
      Each dose is separated by a minimum washout of at least 68 h.&#xD;
&#xD;
      Blood samples for PK analysis of tobramycin will be collected at regular time intervals until&#xD;
      24 h post-dose. For TobrAir 6.0 and TOBI/PARI only, all dosed subjects will undergo&#xD;
      scintigraphic assessments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bioavailability of tobramycin</measure>
    <time_frame>3 days</time_frame>
    <description>Bioavailability of tobramycin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Scintigraphic measurement of lung deposition of radiolabelled tobramycin</measure>
    <time_frame>1 day</time_frame>
    <description>Scintigraphic measurement of lung deposition of radiolabelled tobramycin</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>TobrAir® 6.0</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tobramycin 75mg inhalation solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TOBI® / PARI LC® PLUS Nebulizer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tobramycin 300mg nebulizer solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TOBI® Podhaler™</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tobramycin 112mg (4x28mg) inhalation powder</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tobramycin</intervention_name>
    <arm_group_label>TOBI® / PARI LC® PLUS Nebulizer</arm_group_label>
    <arm_group_label>TOBI® Podhaler™</arm_group_label>
    <arm_group_label>TobrAir® 6.0</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males or non-pregnant, non-lactating healthy females&#xD;
&#xD;
          -  Aged 18 to 65 years&#xD;
&#xD;
          -  Body mass index of 18.0 to 29.0 kg/m2 or, if outside the range, considered not&#xD;
             clinically significant by the investigator&#xD;
&#xD;
          -  Must provide written informed consent&#xD;
&#xD;
          -  Must agree to use an adequate method of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in a clinical research study within the previous 3 months&#xD;
&#xD;
          -  Subjects who have previously been enrolled in this study&#xD;
&#xD;
          -  Females of childbearing potential who are pregnant or lactating (female subjects must&#xD;
             have a negative urine pregnancy test at admission and be using an appropriate method&#xD;
             of contraception)&#xD;
&#xD;
          -  Radiation exposure, including that from the present study, excluding background&#xD;
             radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv&#xD;
             in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker,&#xD;
             as defined in the Ionising Radiation Regulations 1999, shall participate in the study&#xD;
&#xD;
          -  History of chronic respiratory disorders (including asthma) as judged by the&#xD;
             investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pharmaero ApS Pharmaero ApS</last_name>
    <role>Study Director</role>
    <affiliation>Pharmaero ApS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quotient Clinical</name>
      <address>
        <city>Nottingham</city>
        <zip>NG11 6JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>April 7, 2017</last_update_submitted>
  <last_update_submitted_qc>April 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy volunteers</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobramycin</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>November 8, 2022</submitted>
    <returned>September 14, 2023</returned>
  </pending_results>
  <!-- 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/NCT02207426
org study id: TobrAir - CT0040
secondary id: 2013-005288-19
nct id: NCT02207426
lead sponsor: 
has dmc: No
This study compares pharmacokinetic profiles of tobramycin delivered by TobrAir® 6.0 device
      with TOBI® nebulizer system and the TOBI® Podhaler™ device. In addition, lung deposition of
      tobramycin delivered by TobrAir® 6.0 device and by TOBI® nebulizer system will be determined.
This is an open-label, randomized, single dose, cross-over study in healthy subjects. Each
      subject receives tobramycin with 3 different inhalation devices:

        -  75 mg tobramycin delivered to the airways via TobrAir® 6.0.

        -  300 mg tobramycin (TOBI®) delivered to the airways via the PARI LC® PLUS/PARI TurboBoy®
           SX.

        -  112 mg tobramycin (4x28mg dry powder capsules) delivered to the airways via the TOBI®
           Podhaler™.

      Each dose is separated by a minimum washout of at least 68 h.

      Blood samples for PK analysis of tobramycin will be collected at regular time intervals until
      24 h post-dose. For TobrAir 6.0 and TOBI/PARI only, all dosed subjects will undergo
      scintigraphic assessments.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Bioavailability of tobramycin
time frame: 3 days
description: Bioavailability of tobramycin
measure: Scintigraphic measurement of lung deposition of radiolabelled tobramycin
time frame: 1 day
description: Scintigraphic measurement of lung deposition of radiolabelled tobramycin
arm group label: TobrAir® 6.0
arm group type: Experimental
description: Tobramycin 75mg inhalation solution
arm group label: TOBI® / PARI LC® PLUS Nebulizer
arm group type: Experimental
description: Tobramycin 300mg nebulizer solution
arm group label: TOBI® Podhaler™
arm group type: Experimental
description: Tobramycin 112mg (4x28mg) inhalation powder
intervention type: Drug
intervention name: Tobramycin
arm group label: TOBI® / PARI LC® PLUS Nebulizer
arm group label: TOBI® Podhaler™
arm group label: TobrAir® 6.0
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pharmaero ApS Pharmaero ApS
role: Study Director
affiliation: Pharmaero ApS
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Tobramycin
submitted: November 8, 2022
returned: September 14, 2023