<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/NCT01661374</url>
  </required_header>
  <id_info>
    <org_study_id>HM14433</org_study_id>
    <nct_id>NCT01661374</nct_id>
  </id_info>
  <brief_title>The Effect of Humidification on Mucus Rheology</brief_title>
  <official_title>The Effect of Humidification on Mucus Rheology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fisher and Paykel Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Virginia Commonwealth University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study the investigators will collect mucus from mechanical ventilated patients and&#xD;
      patients with COPD to study the effect of temperature and humidity, on the biophysical&#xD;
      properties of the airway mucus. It is hypothesised that changes in inspired gas temperature&#xD;
      and humidity (over time) may affect the biophysical properties of the airway mucus and reduce&#xD;
      the airway's ability to clear mucus, resulting in deleterious clinical affects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Expectorated sputum samples are collected and used to measure the biophysical properties of&#xD;
      mucus secretions. The samples are later exposed to different temperatures and humidity levels&#xD;
      during bench experiments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sputum Collection</measure>
    <time_frame>10 minutes</time_frame>
    <description>Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of sputum.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">18</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease(COPD)</condition>
  <arm_group>
    <arm_group_label>Mechanically Ventilated</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic obstructive pulmonary disease (COPD).</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Sputum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Primary Care Clinic,ICU, Pulmonary Clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Mechanically Ventilated Patients&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        Any Subject Mechanically Ventilated and producing sputum.&#xD;
&#xD;
        Exclusion&#xD;
&#xD;
          -  None&#xD;
&#xD;
        COPD Group&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  40 to 90 years of age suffering from COPD&#xD;
&#xD;
          -  History of mucus production&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruce K Rubin, MEngr, MD, MBA, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23284</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>December 9, 2014</last_update_submitted>
  <last_update_submitted_qc>December 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  </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/NCT01661374
org study id: HM14433
nct id: NCT01661374
lead sponsor: 
collaborator: 
has dmc: No
In this study the investigators will collect mucus from mechanical ventilated patients and
      patients with COPD to study the effect of temperature and humidity, on the biophysical
      properties of the airway mucus. It is hypothesised that changes in inspired gas temperature
      and humidity (over time) may affect the biophysical properties of the airway mucus and reduce
      the airway's ability to clear mucus, resulting in deleterious clinical affects.
Expectorated sputum samples are collected and used to measure the biophysical properties of
      mucus secretions. The samples are later exposed to different temperatures and humidity levels
      during bench experiments.
observational model: Case-Control
time perspective: Prospective
measure: Sputum Collection
time frame: 10 minutes
description: Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of sputum.
arm group label: Mechanically Ventilated
arm group label: Chronic obstructive pulmonary disease (COPD).
Sputum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: No
last name: Bruce K Rubin, MEngr, MD, MBA, FRCPC
role: Principal Investigator
affiliation: Virginia Commonwealth University School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive