<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/NCT04417842</url>
  </required_header>
  <id_info>
    <org_study_id>V1 21APR2020</org_study_id>
    <nct_id>NCT04417842</nct_id>
  </id_info>
  <brief_title>Connect Lung Outcomes With Bronchodilator Use</brief_title>
  <acronym>CLOUD</acronym>
  <official_title>CLOUD Study: Connect Lung Outcomes With Bronchodilator Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pulmonary Critical Care Associates of Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pulmonary Critical Care Associates of Baltimore</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>
      To determine the accuracy of the Respimetrix flow-volume monitoring device in measuring the&#xD;
      patient's inspiratory capacity as compared to gold-standard measurements of inspiratory&#xD;
      capacity on pulmonary function testing. Accuracy will be assessed before and after (A)&#xD;
      pulmonary function testing and before and after (B) the administration of an inhaled&#xD;
      bronchodilator medication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Specific Aim #1: Compare the performance of the flow-volume test device to standard&#xD;
           pulmonary function measurements.&#xD;
&#xD;
           The investigators hypothesize that measurements of inspiratory capacity with the&#xD;
           Respimetrix test device will:&#xD;
&#xD;
           A. Accurately measure the inspiratory capacity as assessed on standard pulmonary&#xD;
           function tests, and will B. Correlate with other measures of pulmonary function&#xD;
           including spirometry (vital capacity, forced expiratory volume in 1 second) and lung&#xD;
           volumes (total lung capacity, functional residual capacity and residual volume).&#xD;
&#xD;
        2. Specific Aim #2: Examine the ability of the flow-volume test device to track changes in&#xD;
           standard pulmonary function measurements after the administration of an inhaled&#xD;
           bronchodilator.&#xD;
&#xD;
      The investigators hypothesize that the Respimetrix test device will:&#xD;
&#xD;
      A. Accurately measure changes in inspiratory capacity in response to a standard dose of a&#xD;
      short acting inhaled beta-agonist (4 puffs albuterol), B. Correlate with immediate changes in&#xD;
      pulmonary function parameters including spirometry (vital capacity, forced expiratory volume&#xD;
      in 1 second) and lung volumes (total lung capacity, functional residual capacity and residual&#xD;
      volume).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 27, 2020</start_date>
  <completion_date type="Actual">April 25, 2022</completion_date>
  <primary_completion_date type="Actual">April 25, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Validation</measure>
    <time_frame>1 year</time_frame>
    <description>Validate the Respimetrix device as compared to pulmonary function test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Validation</measure>
    <time_frame>1 year</time_frame>
    <description>Validate Forced Vital Capacity, Forced expired volume in 1 sec, Total lung capacity and residual volume</description>
  </secondary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Asthma</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Respimetrix flow-volume monitoring device</intervention_name>
    <description>The Respimetrix flow-volume monitoring device is being tested to validate its ability to measure Inspiratory Capacity</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        - Patients 18 years of age or older who are being seen in the pulmonary clinic including&#xD;
        Asthma and COPD patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18 years of age or older who are being seen in the pulmonary clinic including&#xD;
             Asthma and Chronic Obstructive Pulmonary Disease (COPD) patients.&#xD;
&#xD;
          -  Patients must be willing and able to provide informed consent to participate in the&#xD;
             study.&#xD;
&#xD;
          -  Patients must be able to use a metered dose inhaler.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to inhaler use&#xD;
&#xD;
          -  Tracheostomy&#xD;
&#xD;
          -  Incapacitating disability that interferes with the use of the inhaler or execution of&#xD;
             the protocol&#xD;
&#xD;
          -  Unable to understand informed consent (e.g., non-English speakers)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Pulmonary and Critical Care Associates Of Baltimore</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>21286</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>April 26, 2023</last_update_submitted>
  <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pulmonary Critical Care Associates of Baltimore</investigator_affiliation>
    <investigator_full_name>Alan Schwartz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Validating a device for Respimetrix, no immediate plan to share data.</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/NCT04417842
org study id: V1 21APR2020
nct id: NCT04417842
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To determine the accuracy of the Respimetrix flow-volume monitoring device in measuring the
      patient's inspiratory capacity as compared to gold-standard measurements of inspiratory
      capacity on pulmonary function testing. Accuracy will be assessed before and after (A)
      pulmonary function testing and before and after (B) the administration of an inhaled
      bronchodilator medication.
1. Specific Aim #1: Compare the performance of the flow-volume test device to standard
           pulmonary function measurements.

           The investigators hypothesize that measurements of inspiratory capacity with the
           Respimetrix test device will:

           A. Accurately measure the inspiratory capacity as assessed on standard pulmonary
           function tests, and will B. Correlate with other measures of pulmonary function
           including spirometry (vital capacity, forced expiratory volume in 1 second) and lung
           volumes (total lung capacity, functional residual capacity and residual volume).

        2. Specific Aim #2: Examine the ability of the flow-volume test device to track changes in
           standard pulmonary function measurements after the administration of an inhaled
           bronchodilator.

      The investigators hypothesize that the Respimetrix test device will:

      A. Accurately measure changes in inspiratory capacity in response to a standard dose of a
      short acting inhaled beta-agonist (4 puffs albuterol), B. Correlate with immediate changes in
      pulmonary function parameters including spirometry (vital capacity, forced expiratory volume
      in 1 second) and lung volumes (total lung capacity, functional residual capacity and residual
      volume).
observational model: Other
time perspective: Prospective
measure: Validation
time frame: 1 year
description: Validate the Respimetrix device as compared to pulmonary function test
measure: Validation
time frame: 1 year
description: Validate Forced Vital Capacity, Forced expired volume in 1 sec, Total lung capacity and residual volume
intervention type: Diagnostic Test
intervention name: Respimetrix flow-volume monitoring device
description: The Respimetrix flow-volume monitoring device is being tested to validate its ability to measure Inspiratory Capacity
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pulmonary Critical Care Associates of Baltimore
investigator full name: Alan Schwartz
investigator title: Principal Investigator
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No
ipd description: Validating a device for Respimetrix, no immediate plan to share data.