<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/NCT03246581</url>
  </required_header>
  <id_info>
    <org_study_id>CSP-07-000040</org_study_id>
    <nct_id>NCT03246581</nct_id>
  </id_info>
  <brief_title>Two-period 21 Day Cross-over Study to Compare the Pharmacokinetics of Tiotropium From Two Inhalers</brief_title>
  <official_title>Protocol With Amendments 1 and 2: Phase I Randomised, Two-period 21 Day Crossover Study in Healthy Male and Female Volunteers to Compare the Steadystate Pharmacokinetics of Tiotropium Delivered From a Test pMDI Product With Spiriva Respimat</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>3M</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Simbec Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>3M</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the absorption of a test inhalation product with the&#xD;
      reference product in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthy subjects will be enrolled and will receive doses of a test inhalation product and a&#xD;
      reference inhalation product for 28 days according to a crossover design. Plasma tiotropium&#xD;
      levels will be measured predose and over 24 hours postdose on days 1 and 28.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2017</start_date>
  <completion_date type="Actual">May 3, 2018</completion_date>
  <primary_completion_date type="Actual">January 21, 2018</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Plasma Concentration (Cmax)</measure>
    <time_frame>24 hours</time_frame>
    <description>noncompartmental analysis</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Test Product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tiotropium pMDI 2 inhalations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Commercial Product</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>tiotropium pMDI 2 inhalations</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tiotropium</intervention_name>
    <description>inhalation</description>
    <arm_group_label>Commercial Product</arm_group_label>
    <arm_group_label>Test Product</arm_group_label>
    <other_name>Spiriva Respimat</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Volunteer&#xD;
&#xD;
          -  Willing and able to give informed consent&#xD;
&#xD;
          -  Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing&#xD;
             foods and beverages for 24 hours prior to reporting to clinic&#xD;
&#xD;
          -  Subjects must agree to use an adequate method of contraception from admission through&#xD;
             12 weeks after last administration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence or history of clinically significant abnormalities or disease or chronic&#xD;
             respiratory disorders&#xD;
&#xD;
          -  Any presence or history of a clinically significant allergy including any adverse&#xD;
             reaction to study drug&#xD;
&#xD;
          -  History of drug or alcohol abuse within the past 2 years&#xD;
&#xD;
          -  Smoked tobacco within the past 6 months or have a history of more than 10- pack years&#xD;
             (number of packs smoked per day x number of years smoked)&#xD;
&#xD;
          -  Donation or loss of greater than 400 mL of blood within the previous 3 months&#xD;
&#xD;
          -  Have received any prescription medication within 4 weeks or investigational medication&#xD;
             within 12 weeks of study (exception: contraceptives are permitted)&#xD;
&#xD;
          -  Have received any non-prescription medication within 14 days prior to dosing&#xD;
             (exception: paracetamol use within 2 days)&#xD;
&#xD;
          -  Upper respiratory tract infection (excluding otitis media) within 14 days of the first&#xD;
             study day, or lower respiratory tract infection within the last 3 months&#xD;
&#xD;
          -  If female, nursing, lactating or pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Victoria Sessions, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>3M</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>3M Health Care</name>
      <address>
        <city>Loughborough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>July 2, 2018</last_update_submitted>
  <last_update_submitted_qc>July 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>inhalation</keyword>
  <keyword>anticholinergic</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tiotropium Bromide</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/NCT03246581
org study id: CSP-07-000040
nct id: NCT03246581
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the absorption of a test inhalation product with the
      reference product in healthy volunteers.
Healthy subjects will be enrolled and will receive doses of a test inhalation product and a
      reference inhalation product for 28 days according to a crossover design. Plasma tiotropium
      levels will be measured predose and over 24 hours postdose on days 1 and 28.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Peak Plasma Concentration (Cmax)
time frame: 24 hours
description: noncompartmental analysis
arm group label: Test Product
arm group type: Experimental
description: tiotropium pMDI 2 inhalations
arm group label: Commercial Product
arm group type: Active Comparator
description: tiotropium pMDI 2 inhalations
intervention type: Drug
intervention name: Tiotropium
description: inhalation
arm group label: Commercial Product
arm group label: Test Product
other name: Spiriva Respimat
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Victoria Sessions, PhD
role: Study Chair
affiliation: 3M
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Tiotropium Bromide