<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/NCT01714063</url>
  </required_header>
  <id_info>
    <org_study_id>RDD-2010-001</org_study_id>
    <nct_id>NCT01714063</nct_id>
  </id_info>
  <brief_title>Drug Delivery Via Pressurized Metered-dose Inhaler and Valved Holding Chamber in Asthmatic Children: Determination of Delivered Dose Following Coordinated and Uncoordinated Use</brief_title>
  <official_title>Drug Delivery Via Pressurized Metered-dose Inhaler and Valved Holding Chamber in Asthmatic Children: Determination of Delivered Dose Following Coordinated and Uncoordinated Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philips Respironics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philips Respironics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to determine ex vivo the amount of fluticasone&#xD;
      deposited onto a filter (delivered dose) interposed between the OptiChamber Diamond Valved&#xD;
      Holding Chamber (VHC) mouthpiece and the subject's mouth during coordinated and uncoordinated&#xD;
      actuation/inhalation maneuver.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Delivered Dose of Fluticasone (on the Filter)</measure>
    <time_frame>Day 1</time_frame>
    <description>This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Delivered Dose of Fluticasone (on the Filter) Comparing Coordinated and Uncoordinated Maneuvers</measure>
    <time_frame>Day 1</time_frame>
    <description>This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inspiratory Peak Flow</measure>
    <time_frame>Day 1</time_frame>
    <description>Inspiratory peak flow is a person's maximum speed of inspiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe in air.&#xD;
This study compared the inspiratory peak flows of all participants between the coordinated and uncoordinated maneuvers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inspiratory Tidal Volume</measure>
    <time_frame>Day 1</time_frame>
    <description>Inspiratory tidal volume is a person's lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied. In a healthy, young human adult, tidal volume is approximately 500 mL per inspiration or 7 mL/kg of body mass.&#xD;
This study compared the inspiratory tidal volume of all participants between the coordinated and uncoordinated maneuvers.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Measurement Residual Amount of Drug (Fluticasone) Deposited Within the OptiChamber Diamond VHC</measure>
    <time_frame>Day 1</time_frame>
    <description>Collect the residual amount of drug (fluticasone) deposited within the OptiChamber Diamond VHC by washing the internal surfaces of the VHC and the Pressurized Metered Dose Inhaler (pMDI) boot</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">34</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Age 5-6.5</arm_group_label>
    <description>Group 1 will consist of 16 children aged 5-6.5 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aged 6.6- 8 years</arm_group_label>
    <description>Group 2 will consist of 16 children aged 6.6- 8 years</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pressurized Metered-Dose Inhaler</intervention_name>
    <description>Pressurized Metered-Dose Inhaler</description>
    <arm_group_label>Age 5-6.5</arm_group_label>
    <arm_group_label>Aged 6.6- 8 years</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        40 subjects aged 5-8 diagnosed with asthma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Asthmatic children between the ages of 5 and 8 followed at Arkansas Children's&#xD;
             Hospital.&#xD;
&#xD;
               -  The subjects must be available to complete the study.&#xD;
&#xD;
               -  The subject's parent(s) and/or the subject's legal guardian must provide written&#xD;
                  informed consent to participate in the study.&#xD;
&#xD;
               -  The subject must provide assent when older than 7 years old.&#xD;
&#xD;
               -  The subjects should have used a pMDI VHC previously and be able to use a VHC with&#xD;
                  mouthpiece.&#xD;
&#xD;
               -  The subjects should have been prescribed fluticasone or another inhaled&#xD;
                  corticosteroid delivered via a pMDI VHC combination.&#xD;
&#xD;
               -  Clinically stable asthma.&#xD;
&#xD;
               -  Cooperative, i.e., subject should be able to follow and understand instructions.&#xD;
&#xD;
               -  The subject must satisfy the study investigator about his/her fitness to&#xD;
                  participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant respiratory disease in the previous 4 weeks.&#xD;
&#xD;
          -  Participation in any other clinical trial in the previous 4 weeks.&#xD;
&#xD;
          -  Lack of cooperation, subject cannot follow and understand instructions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ariel Berlinski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arkansas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arkansas Children's Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <results_first_submitted>January 9, 2019</results_first_submitted>
  <results_first_submitted_qc>April 23, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 24, 2019</results_first_posted>
  <last_update_submitted>April 23, 2019</last_update_submitted>
  <last_update_submitted_qc>April 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pediatric</keyword>
  <keyword>asthma</keyword>
  <keyword>metered dose inhaler</keyword>
  <keyword>valved holding chamber</keyword>
  <keyword>pMDI</keyword>
  <keyword>VHC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pressurized Metered-Dose Inhaler</title>
          <description>All participants that were consented to use the Pressurized Metered-Dose Inhaler in this study were considered.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Equipment malfunction</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>All participants that were consented to the study were considered.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="32"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.4" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="119.3" spread="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.4" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time Using Valved Holding Chamber</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous Mouthpiece Experience</title>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13" spread="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Delivered Dose of Fluticasone (on the Filter)</title>
        <description>This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient.</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Age 5-6.5</title>
            <description>Group 1 will consist of 16 children aged 5-6.5 years&#xD;
Pressurized Metered-Dose Inhaler: Pressurized Metered-Dose Inhaler</description>
          </group>
          <group group_id="O2">
            <title>Aged 6.6- 8 Years</title>
            <description>Group 2 will consist of 16 children aged 6.6- 8 years&#xD;
Pressurized Metered-Dose Inhaler: Pressurized Metered-Dose Inhaler</description>
          </group>
        </group_list>
        <measure>
          <title>Delivered Dose of Fluticasone (on the Filter)</title>
          <description>This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient.</description>
          <units>Percent filter dose of fluticasone</units>
          <param>Mean</param>
          <dispersion>99% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Coordinated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48" lower_limit="44" upper_limit="52"/>
                    <measurement group_id="O2" value="45" lower_limit="39" upper_limit="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uncoordinated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41" lower_limit="36" upper_limit="47"/>
                    <measurement group_id="O2" value="40" lower_limit="35" upper_limit="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>We used a paired T-test for statistical analysis to compare the filter dose. Using the 1% significance level and assuming a between-subject standard deviation of 60 lg (27%) for the difference between coordinated and doses, 32 subjects are sufficient to detect a 45 lg (20%) difference with 95% confidence.uncoordinated filter</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>paired t-test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Delivered Dose of Fluticasone (on the Filter) Comparing Coordinated and Uncoordinated Maneuvers</title>
        <description>This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient.</description>
        <time_frame>Day 1</time_frame>
        <population>1 participant was excluded from the filter data because they were an outlier</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Data among all participants were compared for the coordinated and uncoordinated effort</description>
          </group>
        </group_list>
        <measure>
          <title>Delivered Dose of Fluticasone (on the Filter) Comparing Coordinated and Uncoordinated Maneuvers</title>
          <description>This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient.</description>
          <population>1 participant was excluded from the filter data because they were an outlier</population>
          <units>Percent filter dose of fluticasone</units>
          <param>Mean</param>
          <dispersion>99% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Coordinated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46" lower_limit="43" upper_limit="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uncoordinated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41" lower_limit="37" upper_limit="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Inspiratory Peak Flow</title>
        <description>Inspiratory peak flow is a person's maximum speed of inspiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe in air.&#xD;
This study compared the inspiratory peak flows of all participants between the coordinated and uncoordinated maneuvers.</description>
        <time_frame>Day 1</time_frame>
        <population>participant was excluded from both the coordinated because of their breathing profile&#xD;
participants were excluded from the uncoordinated effort because of their breathing profile</population>
        <group_list>
          <group group_id="O1">
            <title>Coordinated Effort</title>
            <description>Data among all participants were compared for the coordinated maneuver.</description>
          </group>
          <group group_id="O2">
            <title>Uncoordinated Effort</title>
            <description>Data among all participants were compared for the uncoordinated maneuver.</description>
          </group>
        </group_list>
        <measure>
          <title>Inspiratory Peak Flow</title>
          <description>Inspiratory peak flow is a person's maximum speed of inspiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe in air.&#xD;
This study compared the inspiratory peak flows of all participants between the coordinated and uncoordinated maneuvers.</description>
          <population>participant was excluded from both the coordinated because of their breathing profile&#xD;
participants were excluded from the uncoordinated effort because of their breathing profile</population>
          <units>L/min</units>
          <param>Mean</param>
          <dispersion>99% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1st Breath</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.2" lower_limit="20.5" upper_limit="30"/>
                    <measurement group_id="O2" value="22.8" lower_limit="17.6" upper_limit="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2nd Breath</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.3" lower_limit="18.5" upper_limit="28.1"/>
                    <measurement group_id="O2" value="22" lower_limit="17.3" upper_limit="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3rd Breath</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.2" lower_limit="18.3" upper_limit="28"/>
                    <measurement group_id="O2" value="22.5" lower_limit="17.1" upper_limit="27.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All Breaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.9" lower_limit="21.3" upper_limit="26.5"/>
                    <measurement group_id="O2" value="22.4" lower_limit="19.6" upper_limit="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Inspiratory Tidal Volume</title>
        <description>Inspiratory tidal volume is a person's lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied. In a healthy, young human adult, tidal volume is approximately 500 mL per inspiration or 7 mL/kg of body mass.&#xD;
This study compared the inspiratory tidal volume of all participants between the coordinated and uncoordinated maneuvers.</description>
        <time_frame>Day 1</time_frame>
        <population>participant was excluded from both the coordinated because of their breathing profile&#xD;
participants were excluded from the uncoordinated effort because of their breathing profile</population>
        <group_list>
          <group group_id="O1">
            <title>Coordinated Effort</title>
            <description>Data among all participants were compared for the coordinated maneuver.</description>
          </group>
          <group group_id="O2">
            <title>Uncoordinated Effort</title>
            <description>Data among all participants were compared for the uncoordinated maneuver.</description>
          </group>
        </group_list>
        <measure>
          <title>Inspiratory Tidal Volume</title>
          <description>Inspiratory tidal volume is a person's lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied. In a healthy, young human adult, tidal volume is approximately 500 mL per inspiration or 7 mL/kg of body mass.&#xD;
This study compared the inspiratory tidal volume of all participants between the coordinated and uncoordinated maneuvers.</description>
          <population>participant was excluded from both the coordinated because of their breathing profile&#xD;
participants were excluded from the uncoordinated effort because of their breathing profile</population>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>99% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1st Breath</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="286" lower_limit="209" upper_limit="363"/>
                    <measurement group_id="O2" value="269" lower_limit="212" upper_limit="362"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2nd Breath</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="281" lower_limit="215" upper_limit="363"/>
                    <measurement group_id="O2" value="259" lower_limit="186" upper_limit="333"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3rd Breath</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="302" lower_limit="227" upper_limit="378"/>
                    <measurement group_id="O2" value="266" lower_limit="201" upper_limit="331"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="291" lower_limit="250" upper_limit="332"/>
                    <measurement group_id="O2" value="271" lower_limit="228" upper_limit="314"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Measurement Residual Amount of Drug (Fluticasone) Deposited Within the OptiChamber Diamond VHC</title>
        <description>Collect the residual amount of drug (fluticasone) deposited within the OptiChamber Diamond VHC by washing the internal surfaces of the VHC and the Pressurized Metered Dose Inhaler (pMDI) boot</description>
        <time_frame>Day 1</time_frame>
        <population>This is a measure of an inhaler study, not a nebulizer study. Therefore this data was not collected or analyzed as it would not be applicable to this type of study.</population>
        <group_list>
          <group group_id="O1">
            <title>Coordinated Effort</title>
            <description>Data among all participants were compared for the coordinated maneuver.</description>
          </group>
          <group group_id="O2">
            <title>Uncoordinated Effort</title>
            <description>Data among all participants were compared for the uncoordinated maneuver.</description>
          </group>
        </group_list>
        <measure>
          <title>Measurement Residual Amount of Drug (Fluticasone) Deposited Within the OptiChamber Diamond VHC</title>
          <description>Collect the residual amount of drug (fluticasone) deposited within the OptiChamber Diamond VHC by washing the internal surfaces of the VHC and the Pressurized Metered Dose Inhaler (pMDI) boot</description>
          <population>This is a measure of an inhaler study, not a nebulizer study. Therefore this data was not collected or analyzed as it would not be applicable to this type of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 day</time_frame>
      <group_list>
        <group group_id="E1">
          <title>All Study Participants</title>
          <description>All participants that were consented to the study were considered.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ariel Perlinkski MT</name_or_title>
      <organization>Department of Pediatrics UAMS/COM</organization>
      <email>berlinskiariel@uams.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01714063
org study id: RDD-2010-001
nct id: NCT01714063
lead sponsor: 
has dmc: No
The primary objective of this study is to determine ex vivo the amount of fluticasone
      deposited onto a filter (delivered dose) interposed between the OptiChamber Diamond Valved
      Holding Chamber (VHC) mouthpiece and the subject's mouth during coordinated and uncoordinated
      actuation/inhalation maneuver.
observational model: Case-Only
time perspective: Prospective
measure: Delivered Dose of Fluticasone (on the Filter)
time frame: Day 1
description: This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient.
measure: Delivered Dose of Fluticasone (on the Filter) Comparing Coordinated and Uncoordinated Maneuvers
time frame: Day 1
description: This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient.
measure: Inspiratory Peak Flow
time frame: Day 1
description: Inspiratory peak flow is a person's maximum speed of inspiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe in air.
This study compared the inspiratory peak flows of all participants between the coordinated and uncoordinated maneuvers.
measure: Inspiratory Tidal Volume
time frame: Day 1
description: Inspiratory tidal volume is a person's lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied. In a healthy, young human adult, tidal volume is approximately 500 mL per inspiration or 7 mL/kg of body mass.
This study compared the inspiratory tidal volume of all participants between the coordinated and uncoordinated maneuvers.
measure: Measurement Residual Amount of Drug (Fluticasone) Deposited Within the OptiChamber Diamond VHC
time frame: Day 1
description: Collect the residual amount of drug (fluticasone) deposited within the OptiChamber Diamond VHC by washing the internal surfaces of the VHC and the Pressurized Metered Dose Inhaler (pMDI) boot
arm group label: Age 5-6.5
description: Group 1 will consist of 16 children aged 5-6.5 years
arm group label: Aged 6.6- 8 years
description: Group 2 will consist of 16 children aged 6.6- 8 years
intervention type: Device
intervention name: Pressurized Metered-Dose Inhaler
description: Pressurized Metered-Dose Inhaler
arm group label: Age 5-6.5
arm group label: Aged 6.6- 8 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 8 Years
healthy volunteers: No
last name: Ariel Berlinski, MD
role: Principal Investigator
affiliation: University of Arkansas
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 