<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/NCT03302065</url>
  </required_header>
  <id_info>
    <org_study_id>CSP-07-000030</org_study_id>
    <nct_id>NCT03302065</nct_id>
  </id_info>
  <brief_title>Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Reference</brief_title>
  <official_title>Phase I Randomised, Four-period Balanced Incomplete Block Design Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Four Test pMDI Products With One Reference Product</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>3M</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </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 four different inhalation products&#xD;
      with the reference product in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthy subjects will be enrolled and will receive single doses of 4 test inhalation products&#xD;
      and two reference inhalation products according to a five-period cross-over design. Plasma&#xD;
      tiotropium levels will be measured pre-dose and over 48 hours post-dose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Cmax</measure>
    <time_frame>48 hours</time_frame>
    <description>maximum plasma concentration</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Test Product 1 Tiotropium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 inhalations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Product 2 Tiotropium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 inhalations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Product 3 Tiotropium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 inhalations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference Tiotropium</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 inhalations</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tiotropium</intervention_name>
    <arm_group_label>Reference Tiotropium</arm_group_label>
    <arm_group_label>Test Product 1 Tiotropium</arm_group_label>
    <arm_group_label>Test Product 2 Tiotropium</arm_group_label>
    <arm_group_label>Test Product 3 Tiotropium</arm_group_label>
    <other_name>Spiriva</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;
&#xD;
          -  Regular alcohol consumption in males &gt;21 units per week and females &gt;14 units per week&#xD;
             (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)&#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>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>October 2, 2017</last_update_submitted>
  <last_update_submitted_qc>October 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2017</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>results will be shared through publication</ipd_description>
  </patient_data>
  <!-- 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/NCT03302065
org study id: CSP-07-000030
nct id: NCT03302065
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the absorption of four different inhalation products
      with the reference product in healthy volunteers.
Healthy subjects will be enrolled and will receive single doses of 4 test inhalation products
      and two reference inhalation products according to a five-period cross-over design. Plasma
      tiotropium levels will be measured pre-dose and over 48 hours post-dose.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Cmax
time frame: 48 hours
description: maximum plasma concentration
arm group label: Test Product 1 Tiotropium
arm group type: Experimental
description: 4 inhalations
arm group label: Test Product 2 Tiotropium
arm group type: Experimental
description: 4 inhalations
arm group label: Test Product 3 Tiotropium
arm group type: Experimental
description: 4 inhalations
arm group label: Reference Tiotropium
arm group type: Active Comparator
description: 2 inhalations
intervention type: Drug
intervention name: Tiotropium
arm group label: Reference Tiotropium
arm group label: Test Product 1 Tiotropium
arm group label: Test Product 2 Tiotropium
arm group label: Test Product 3 Tiotropium
other name: Spiriva
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
responsible party type: Sponsor
mesh term: Tiotropium Bromide
sharing ipd: No
ipd description: results will be shared through publication