<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/NCT01712854</url>
  </required_header>
  <id_info>
    <org_study_id>AAAI1932</org_study_id>
    <nct_id>NCT01712854</nct_id>
  </id_info>
  <brief_title>Effects of Symbicort on the Ventilatory Kinematics</brief_title>
  <official_title>Investigating the Effects of Symbicort on the Ventilatory Kinematics in Patients With Obstructive Disease With Optoelectronic Plethysmography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate how budesonide/formoterol fumarate dihydrate&#xD;
      (Symbicort ©) affects dynamic hyperinflation in patients with obstructive disease using&#xD;
      Optoelectronic Plethysmography (OEP). This study is unique as it will be the first&#xD;
      randomized, doubleblind, crossover study with a placebo inhaler and budesonide/formoterol&#xD;
      fumarate dihydrate as the intervention which will evaluate the effects on ventilatory&#xD;
      mechanics through the use of OEP. The investigators plan to demonstrate that&#xD;
      budesonide/formoterol fumarate dihydrate impacts dynamic hyperinflation which can be detected&#xD;
      with OEP, and that budesonide/formoterol fumarate dihydrate may have an effect in the short&#xD;
      term on exercise capacity during a constant load exercise test. The changes in ventilatory&#xD;
      mechanics measured after budesonide/formoterol fumarate dihydrate by OEP will provide a&#xD;
      unique evaluation of budesonide/formoterol fumarate dihydrate in a controlled setting also&#xD;
      demonstrating the utility of OEP in evaluating of the effects of a medical treatment on&#xD;
      hyperinflation in individuals with chronic obstructive lung disease (COPD).&#xD;
&#xD;
        1. Primary Objective/Hypothesis: Our objective is to measure baseline, post treatment and&#xD;
           post exercise spirometry and evaluate exercise dynamic hyperinflation before and after&#xD;
           treatment using OEP. The investigators hypothesize that budesonide/formoterol fumarate&#xD;
           dihydrate will decrease dynamic hyperinflation as measured by OEP.&#xD;
&#xD;
        2. Primary Endpoint: Our primary endpoint is the change in dynamic hyperinflation,&#xD;
           specifically end expiratory volumes, dynamic lung volumes and diaphragmatic paradoxical&#xD;
           breathing as measured by OEP.&#xD;
&#xD;
        3. Secondary Objective: Our secondary objective is to evaluate duration of steady state&#xD;
           exercise and exercise capacity before and after treatment. Our secondary hypothesis is&#xD;
           that decreases in dynamic hyperinflation during exercise will lead to improvements in&#xD;
           dyspnea with exercise, and allow for increases in exercise capacity.&#xD;
&#xD;
        4. Secondary endpoint: Exercise time, change in Borg scale at rest vs. Borg scale at steady&#xD;
           state vs. Borg at end exercise.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a prospective, randomized, double blind, crossover interventional design.&#xD;
      The crossover allows for equality in number of subjects assigned to each treatment and for&#xD;
      subjects to be their own controls. Baseline spirometry will be taken prior to exercise test.&#xD;
      Subjects will be prepared for OEP. All exercise will take place on an electromagnetically&#xD;
      braked cycle ergometer. Throughout the protocol heart rate, blood pressure, O2 saturation,&#xD;
      ventilation, and metabolic data will be recorded. A modified exercise induced asthma protocol&#xD;
      will be used. Unlike prior studies, ventilatory kinematics (with isolated diaphragmatic&#xD;
      function) will be monitored throughout exercise using biomechanical motion analysis (OEP).&#xD;
      This OEP analysis involves compartmentalization of the chest into three sections; 1)&#xD;
      pulmonary rib cage, 2) diaphragmatic rib cage, and 3) abdomen to determine the contribution&#xD;
      of each component to total lung volume. By measuring the percent contribution of compartment,&#xD;
      we are able to better understand its impact on respiration. OEP will be able to quantify and&#xD;
      assess the distortion effects of dynamic hyperinflation and obstruction.&#xD;
&#xD;
      Twenty moderate to severe COPD patients will be recruited. Subjects will refrain from their&#xD;
      usual inhaled medications for 24 hours prior to the testing session. All subjects will be&#xD;
      asked to verify that this is acceptable with their pulmonologist prior to participation.&#xD;
      Subjects will also be asked to have their short acting bronchodilators and other regular&#xD;
      medications available to be taken if symptoms should occur. During the initial screening,&#xD;
      subjects will be familiarized with all procedures. Then baseline pulmonary function testing,&#xD;
      and baseline resting OEP measurements will be performed. The subjects will then be randomized&#xD;
      to receive either budesonide/formoterol fumarate dihydrate (Symbicort) or a placebo of&#xD;
      budesonide only (Entocort EC). At that time, they will receive treatment with either placebo&#xD;
      or budesonide/formoterol fumarate dihydrate and after 45 minutes, they will repeat spirometry&#xD;
      and OEP and submaximal exercise testing with OEP. After one week, subjects will be tested&#xD;
      again and switched to the opposite treatment (i.e. if on budesonide/formoterol fumarate&#xD;
      dihydrate initially then switch to placebo and vice versa). The one week washout period&#xD;
      between tests will include a resumption of the usual medications. The subjects will refrain&#xD;
      from their inhaled medications for 24 hours before the second testing session, but use all of&#xD;
      their other usual medications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Closed by study sponsor; PI left the institution; responsible party changed to Columbia&#xD;
  </why_stopped>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Change in Dynamic Hyperinflation Measured by End Expiratory Volumes Recorded by Optoelectronic Plethysmography (OEP).</measure>
    <time_frame>2 hours</time_frame>
    <description>Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. We hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exercise Time in Steady State Exercise</measure>
    <time_frame>2 hours</time_frame>
    <description>Our secondary objective is to evaluate duration of steady state exercise and exercise capacity before and after treatment. Our secondary hypothesis is that decreases in dynamic hyperinflation during exercise will lead to improvements in dyspnea with exercise, and allow for increases in exercise capacity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Chronic Obstructive Lung Disease</condition>
  <arm_group>
    <arm_group_label>Symbicort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A combination of budesonide + long acting beta agonist (Symbicort): Budesonide 80 mcg and formoterol fumarate dihydrate inhaler 4.5 mcg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Budesonide only</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Budesonide 80 mcg (Entocort EC) only</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Budesonide</intervention_name>
    <description>budesonide 80 mcg</description>
    <arm_group_label>Budesonide only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Symbicort</intervention_name>
    <description>A combination of budesonide and long acting beta agonist: Budesonide 80 mcg and formoterol fumarate dihydrate inhaler 4.5 mcg</description>
    <arm_group_label>Symbicort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderate to severe COPD by Global Initiative for Chronic Obstructive Lung Disease&#xD;
             (GOLD) criteria&#xD;
&#xD;
          -  Approval by pulmonologist&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Age 40 to 75&#xD;
&#xD;
          -  Males and females&#xD;
&#xD;
          -  All races&#xD;
&#xD;
          -  Ex smoker or non smoker&#xD;
&#xD;
          -  Prior therapy allowed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No active cardiac disease&#xD;
&#xD;
          -  Alpha1 Antitrypsin Deficiency&#xD;
&#xD;
          -  Active smoking&#xD;
&#xD;
          -  Reactive Airways Disease&#xD;
&#xD;
          -  Pulmonary Hypertension&#xD;
&#xD;
          -  Comorbid conditions preventing exercise (arthritic, neurologic, vascular, or other&#xD;
             conditions)&#xD;
&#xD;
          -  BMI&gt;30&#xD;
&#xD;
          -  Current enrollment in any other concurrent study at Columbia University Medical Center&#xD;
             or sponsored by AstraZeneca at any other sites&#xD;
&#xD;
          -  Participation in any pharmacologic studies in the last 6 months prior to enrollment in&#xD;
             this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Bartels, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>October 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <results_first_submitted>March 23, 2016</results_first_submitted>
  <results_first_submitted_qc>March 23, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 22, 2016</results_first_posted>
  <last_update_submitted>July 22, 2016</last_update_submitted>
  <last_update_submitted_qc>July 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Chronic Obstructive Lung Disease</keyword>
  <keyword>Long acting beta agonist</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Budesonide</mesh_term>
    <mesh_term>Budesonide, Formoterol Fumarate Drug Combination</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Active Medication or Placebo</title>
          <description>Data per arm is not available. Columbia will never have access to this data.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Active Medication or Placebo</title>
          <description>Data per arm is not available. Columbia will never have access to this data.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Between 40 and 75 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <description>Gender breakdown is not available. Columbia will never have access to this data.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Male and Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Change in Dynamic Hyperinflation Measured by End Expiratory Volumes Recorded by Optoelectronic Plethysmography (OEP).</title>
        <description>Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. We hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP.</description>
        <time_frame>2 hours</time_frame>
        <population>The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.</population>
        <group_list>
          <group group_id="O1">
            <title>Active Medication or Placebo</title>
            <description>Data per arm is not available. Columbia will never have access to this data.</description>
          </group>
        </group_list>
        <measure>
          <title>The Change in Dynamic Hyperinflation Measured by End Expiratory Volumes Recorded by Optoelectronic Plethysmography (OEP).</title>
          <description>Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. We hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP.</description>
          <population>The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Exercise Time in Steady State Exercise</title>
        <description>Our secondary objective is to evaluate duration of steady state exercise and exercise capacity before and after treatment. Our secondary hypothesis is that decreases in dynamic hyperinflation during exercise will lead to improvements in dyspnea with exercise, and allow for increases in exercise capacity.</description>
        <time_frame>2 hours</time_frame>
        <population>The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.</population>
        <group_list>
          <group group_id="O1">
            <title>Active Medication or Placebo</title>
            <description>Data per arm is not available. Columbia will never have access to this data.</description>
          </group>
        </group_list>
        <measure>
          <title>Exercise Time in Steady State Exercise</title>
          <description>Our secondary objective is to evaluate duration of steady state exercise and exercise capacity before and after treatment. Our secondary hypothesis is that decreases in dynamic hyperinflation during exercise will lead to improvements in dyspnea with exercise, and allow for increases in exercise capacity.</description>
          <population>The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.</desc>
      <group_list>
        <group group_id="E1">
          <title>Active Medication or Placebo</title>
          <description>Data per arm is not available. Columbia will never have access to this data.</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="0"/>
              </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="0"/>
              </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>CU PRS Administrator</name_or_title>
      <organization>Columbia University</organization>
      <phone>212-342-1643</phone>
      <email>crchelp@columbia.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/NCT01712854
org study id: AAAI1932
nct id: NCT01712854
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to investigate how budesonide/formoterol fumarate dihydrate
      (Symbicort ©) affects dynamic hyperinflation in patients with obstructive disease using
      Optoelectronic Plethysmography (OEP). This study is unique as it will be the first
      randomized, doubleblind, crossover study with a placebo inhaler and budesonide/formoterol
      fumarate dihydrate as the intervention which will evaluate the effects on ventilatory
      mechanics through the use of OEP. The investigators plan to demonstrate that
      budesonide/formoterol fumarate dihydrate impacts dynamic hyperinflation which can be detected
      with OEP, and that budesonide/formoterol fumarate dihydrate may have an effect in the short
      term on exercise capacity during a constant load exercise test. The changes in ventilatory
      mechanics measured after budesonide/formoterol fumarate dihydrate by OEP will provide a
      unique evaluation of budesonide/formoterol fumarate dihydrate in a controlled setting also
      demonstrating the utility of OEP in evaluating of the effects of a medical treatment on
      hyperinflation in individuals with chronic obstructive lung disease (COPD).

        1. Primary Objective/Hypothesis: Our objective is to measure baseline, post treatment and
           post exercise spirometry and evaluate exercise dynamic hyperinflation before and after
           treatment using OEP. The investigators hypothesize that budesonide/formoterol fumarate
           dihydrate will decrease dynamic hyperinflation as measured by OEP.

        2. Primary Endpoint: Our primary endpoint is the change in dynamic hyperinflation,
           specifically end expiratory volumes, dynamic lung volumes and diaphragmatic paradoxical
           breathing as measured by OEP.

        3. Secondary Objective: Our secondary objective is to evaluate duration of steady state
           exercise and exercise capacity before and after treatment. Our secondary hypothesis is
           that decreases in dynamic hyperinflation during exercise will lead to improvements in
           dyspnea with exercise, and allow for increases in exercise capacity.

        4. Secondary endpoint: Exercise time, change in Borg scale at rest vs. Borg scale at steady
           state vs. Borg at end exercise.
This study will be a prospective, randomized, double blind, crossover interventional design.
      The crossover allows for equality in number of subjects assigned to each treatment and for
      subjects to be their own controls. Baseline spirometry will be taken prior to exercise test.
      Subjects will be prepared for OEP. All exercise will take place on an electromagnetically
      braked cycle ergometer. Throughout the protocol heart rate, blood pressure, O2 saturation,
      ventilation, and metabolic data will be recorded. A modified exercise induced asthma protocol
      will be used. Unlike prior studies, ventilatory kinematics (with isolated diaphragmatic
      function) will be monitored throughout exercise using biomechanical motion analysis (OEP).
      This OEP analysis involves compartmentalization of the chest into three sections; 1)
      pulmonary rib cage, 2) diaphragmatic rib cage, and 3) abdomen to determine the contribution
      of each component to total lung volume. By measuring the percent contribution of compartment,
      we are able to better understand its impact on respiration. OEP will be able to quantify and
      assess the distortion effects of dynamic hyperinflation and obstruction.

      Twenty moderate to severe COPD patients will be recruited. Subjects will refrain from their
      usual inhaled medications for 24 hours prior to the testing session. All subjects will be
      asked to verify that this is acceptable with their pulmonologist prior to participation.
      Subjects will also be asked to have their short acting bronchodilators and other regular
      medications available to be taken if symptoms should occur. During the initial screening,
      subjects will be familiarized with all procedures. Then baseline pulmonary function testing,
      and baseline resting OEP measurements will be performed. The subjects will then be randomized
      to receive either budesonide/formoterol fumarate dihydrate (Symbicort) or a placebo of
      budesonide only (Entocort EC). At that time, they will receive treatment with either placebo
      or budesonide/formoterol fumarate dihydrate and after 45 minutes, they will repeat spirometry
      and OEP and submaximal exercise testing with OEP. After one week, subjects will be tested
      again and switched to the opposite treatment (i.e. if on budesonide/formoterol fumarate
      dihydrate initially then switch to placebo and vice versa). The one week washout period
      between tests will include a resumption of the usual medications. The subjects will refrain
      from their inhaled medications for 24 hours before the second testing session, but use all of
      their other usual medications.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The Change in Dynamic Hyperinflation Measured by End Expiratory Volumes Recorded by Optoelectronic Plethysmography (OEP).
time frame: 2 hours
description: Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. We hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP.
measure: Exercise Time in Steady State Exercise
time frame: 2 hours
description: Our secondary objective is to evaluate duration of steady state exercise and exercise capacity before and after treatment. Our secondary hypothesis is that decreases in dynamic hyperinflation during exercise will lead to improvements in dyspnea with exercise, and allow for increases in exercise capacity.
arm group label: Symbicort
arm group type: Experimental
description: A combination of budesonide + long acting beta agonist (Symbicort): Budesonide 80 mcg and formoterol fumarate dihydrate inhaler 4.5 mcg
arm group label: Budesonide only
arm group type: Placebo Comparator
description: Budesonide 80 mcg (Entocort EC) only
intervention type: Drug
intervention name: Budesonide
description: budesonide 80 mcg
arm group label: Budesonide only
intervention type: Drug
intervention name: Symbicort
description: A combination of budesonide and long acting beta agonist: Budesonide 80 mcg and formoterol fumarate dihydrate inhaler 4.5 mcg
arm group label: Symbicort
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Matthew Bartels, MD, MPH
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Budesonide
mesh term: Budesonide, Formoterol Fumarate Drug Combination
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 