<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/NCT01690949</url>
  </required_header>
  <id_info>
    <org_study_id>601-0005</org_study_id>
    <nct_id>NCT01690949</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers</brief_title>
  <official_title>Single-blind Evaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pulmatrix Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pulmatrix Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial in healthy subjects will assess PUR118's effect on attenuating ozone induced&#xD;
      airway inflammation. This trial will establish the tolerability of PUR118 in healthy normal&#xD;
      volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in sputum cell counts and inflammatory markers</measure>
    <time_frame>6 hours post-initiation of ozone challenge</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in white blood cell and inflammatory biomarker counts in blood</measure>
    <time_frame>7 and 24 hours post-initiation of ozone challenge</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in pulmonary function</measure>
    <time_frame>all post-dose timepoints up to 24 hours post-initiation of ozone challenge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in clinical signs and symptoms from physical examination at baseline</measure>
    <time_frame>Subjects will be followed for an expected average of 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in clinical safety laboratory tests from baseline</measure>
    <time_frame>Subjects will be followed for an expected average of 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in vital signs from baseline</measure>
    <time_frame>Subjects will be followed for an expected average of 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in ECG from baseline</measure>
    <time_frame>Subjects will be followed for an expected average of 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>Subjects will be followed for an expected average of 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease (COPD)</condition>
  <arm_group>
    <arm_group_label>PUR118 low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PUR118 mid dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PUR118 high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PUR118</intervention_name>
    <description>inhaled PUR118, BID</description>
    <arm_group_label>PUR118 high dose</arm_group_label>
    <arm_group_label>PUR118 low dose</arm_group_label>
    <arm_group_label>PUR118 mid dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males or non pregnant, non lactating healthy females age 18-50 years;&#xD;
&#xD;
          -  Must be able to produce acceptable sputum sample by induction;&#xD;
&#xD;
          -  Must respond to ozone inhalation with a &gt; 10% increase in the absolute percentage of&#xD;
             sputum neutrophils and the total neutrophils (neutrophils/gram sputum) must increase&#xD;
             by at least 50% from the sputum neutrophil count at screening;&#xD;
&#xD;
          -  Volunteer is a non-smoker or ex-smoker of at least 12 months' duration prior to&#xD;
             screening with a history of less than 1 pack per year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Volunteers receiving chronic medication other than oral contraceptives;&#xD;
&#xD;
          -  Screening forced expiratory volume FEV1 is &lt; 80% of the predicted value for their age,&#xD;
             gender, height and race and/or their FEV1/FVC ration is below 70%;&#xD;
&#xD;
          -  Volunteers with significant occupational exposure to respiratory irritants or toxins&#xD;
&#xD;
          -  Upper respiratory tract infection within 30 days of the first study day, or lower&#xD;
             respiratory tract infection within the last 3 months;&#xD;
&#xD;
          -  Volunteers taking any medication that may affect the respiratory tract within 30 days&#xD;
             of the first study day;&#xD;
&#xD;
          -  Volunteers with a history of asthma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Hanrahan, MD</last_name>
    <role>Study Director</role>
    <affiliation>Pulmatrix Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fraunhofer Institut fur Toxicologie und Experimentelle Medicine (ITEM)</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>July 18, 2013</last_update_submitted>
  <last_update_submitted_qc>July 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 19, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>inflammation</keyword>
  <keyword>COPD</keyword>
  <keyword>respiratory disease</keyword>
  <keyword>healthy volunteers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_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/NCT01690949
org study id: 601-0005
nct id: NCT01690949
lead sponsor: 
has dmc: No
This trial in healthy subjects will assess PUR118's effect on attenuating ozone induced
      airway inflammation. This trial will establish the tolerability of PUR118 in healthy normal
      volunteers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change from baseline in sputum cell counts and inflammatory markers
time frame: 6 hours post-initiation of ozone challenge
measure: Change from baseline in white blood cell and inflammatory biomarker counts in blood
time frame: 7 and 24 hours post-initiation of ozone challenge
measure: Change from baseline in pulmonary function
time frame: all post-dose timepoints up to 24 hours post-initiation of ozone challenge
measure: Changes in clinical signs and symptoms from physical examination at baseline
time frame: Subjects will be followed for an expected average of 12 weeks
measure: Changes in clinical safety laboratory tests from baseline
time frame: Subjects will be followed for an expected average of 12 weeks
measure: Changes in vital signs from baseline
time frame: Subjects will be followed for an expected average of 12 weeks
measure: Changes in ECG from baseline
time frame: Subjects will be followed for an expected average of 12 weeks
measure: Number of subjects with adverse events
time frame: Subjects will be followed for an expected average of 12 weeks
arm group label: PUR118 low dose
arm group type: Experimental
arm group label: PUR118 mid dose
arm group type: Experimental
arm group label: PUR118 high dose
arm group type: Experimental
intervention type: Drug
intervention name: PUR118
description: inhaled PUR118, BID
arm group label: PUR118 high dose
arm group label: PUR118 low dose
arm group label: PUR118 mid dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John Hanrahan, MD
role: Study Director
affiliation: Pulmatrix Inc.
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Inflammation