<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/NCT03270332</url>
  </required_header>
  <id_info>
    <org_study_id>20170552</org_study_id>
    <nct_id>NCT03270332</nct_id>
  </id_info>
  <brief_title>Effect of Inhaled Albuterol in Pulmonary Hypertension</brief_title>
  <official_title>Effect of Inhaled Albuterol on Pulmonary Hemodynamics in Patients With Group 1 Pulmonary Arterial Hypertension on Oral Pulmonary Vasodilator Therapy: A Proof of Concept Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the present pilot study is to test the hypothesis that in patients with group&#xD;
      1 pulmonary arterial hypertension (PAH) who are on regular oral pulmonary vasodilator&#xD;
      therapy, inhaled albuterol causes transient pulmonary vasodilation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2017</start_date>
  <completion_date type="Actual">July 2, 2020</completion_date>
  <primary_completion_date type="Actual">July 2, 2020</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Mean Pulmonary Artery Pressure (MPAP)</measure>
    <time_frame>Baseline, up to 30 minutes after inhalation</time_frame>
    <description>Change in MPAP will be measured using echocardiogram</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pulmonary Vascular Resistance (PVR)</measure>
    <time_frame>Baseline, up to 30 minutes after inhalation</time_frame>
    <description>Change in PVR will be measured using echocardiogram</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Pulmonary Hypertension</condition>
  <arm_group>
    <arm_group_label>Albuterol followed by placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive albuterol first followed by Placebo on the next visit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo followed by albuterol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive placebo first followed by albuterol on the next visit</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albuterol</intervention_name>
    <description>inhalation of 270μg albuterol through a spacer</description>
    <arm_group_label>Albuterol followed by placebo</arm_group_label>
    <arm_group_label>Placebo followed by albuterol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>inhalation of placebo through a spacer</description>
    <arm_group_label>Albuterol followed by placebo</arm_group_label>
    <arm_group_label>Placebo followed by albuterol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A Mean Pulmonary Artery Pressure &gt;25mmHg, Pulmonary Vascular Resistance &gt;3 wood/units&#xD;
             and pulmonary arterial wedge pressure &lt;15mmHg, as documented by right heart&#xD;
             catheterization within the last 3 years&#xD;
&#xD;
          -  Regular use of oral pulmonary vasodilators&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of chronic respiratory disease (as documented by prior lung imaging and&#xD;
             pulmonary function tests), cardiovascular disease (as documented by prior&#xD;
             echocardiography and/or left heart catheterization), thromboembolic PAH (as documented&#xD;
             by pulmonary angiography)&#xD;
&#xD;
          -  women of childbearing potential who do not use accepted birth- control measures&#xD;
&#xD;
          -  pregnant and breast-feeding women&#xD;
&#xD;
          -  respiratory infection within 4 weeks of testing&#xD;
&#xD;
          -  A systemic systolic arterial BP&gt; 150 and/or diastolic arterial BP&gt;100 on the&#xD;
             experiment day&#xD;
&#xD;
          -  A resting O2 saturation of &lt; 90%&#xD;
&#xD;
          -  Current smoking&#xD;
&#xD;
          -  BMI &gt;35 kg/m2 and/or a diagnosis of obstructive sleep apnea&#xD;
&#xD;
          -  Use of inhaled or intravenous pulmonary vasodilators&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adam Wanner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <results_first_submitted>August 4, 2021</results_first_submitted>
  <results_first_submitted_qc>August 4, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 30, 2021</results_first_posted>
  <last_update_submitted>August 4, 2021</last_update_submitted>
  <last_update_submitted_qc>August 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Adam Wanner</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Albuterol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 4, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT03270332/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Albuterol Followed by Placebo</title>
          <description>Participants in this group will receive albuterol first followed by Placebo on the next visit&#xD;
Albuterol: inhalation of 270μg albuterol through a spacer&#xD;
Placebo: inhalation of placebo through a spacer</description>
        </group>
        <group group_id="P2">
          <title>Placebo Followed by Albuterol</title>
          <description>Participants in this group will receive placebo first followed by albuterol on the next visit&#xD;
Albuterol: inhalation of 270μg albuterol through a spacer&#xD;
Placebo: inhalation of placebo through a spacer</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Albuterol Followed by Placebo</title>
          <description>Participants in this group will receive albuterol first followed by Placebo on the next visit&#xD;
Albuterol: inhalation of 270μg albuterol through a spacer&#xD;
Placebo: inhalation of placebo through a spacer</description>
        </group>
        <group group_id="B2">
          <title>Placebo Followed by Albuterol</title>
          <description>Participants in this group will receive placebo first followed by albuterol on the next visit&#xD;
Albuterol: inhalation of 270μg albuterol through a spacer&#xD;
Placebo: inhalation of placebo through a spacer</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Mean Pulmonary Artery Pressure (MPAP)</title>
        <description>Change in MPAP will be measured using echocardiogram</description>
        <time_frame>Baseline, up to 30 minutes after inhalation</time_frame>
        <population>This is a cross-over study design. All enrolled participants received both the albuterol and placebo intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Albuterol Group</title>
            <description>This is a cross-over study design. All participants received albuterol</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>This is a cross-over design. All participants received placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Pulmonary Artery Pressure (MPAP)</title>
          <description>Change in MPAP will be measured using echocardiogram</description>
          <population>This is a cross-over study design. All enrolled participants received both the albuterol and placebo intervention.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="2.8"/>
                    <measurement group_id="O2" value="4.3" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pulmonary Vascular Resistance (PVR)</title>
        <description>Change in PVR will be measured using echocardiogram</description>
        <time_frame>Baseline, up to 30 minutes after inhalation</time_frame>
        <population>This is a cross-over study design. All enrolled participants received both the albuterol and placebo intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Albuterol Group</title>
            <description>This is a cross-over study. All participants received albuterol.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>This is a cross-over study. All participants received placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pulmonary Vascular Resistance (PVR)</title>
          <description>Change in PVR will be measured using echocardiogram</description>
          <population>This is a cross-over study design. All enrolled participants received both the albuterol and placebo intervention.</population>
          <units>dyn.s.cm-5</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="217" spread="92"/>
                    <measurement group_id="O2" value="108" spread="153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 day</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Albuterol Group</title>
          <description>This is a cross-over study. All participants received albuterol.</description>
        </group>
        <group group_id="E2">
          <title>Placebo Group</title>
          <description>This is a cross-over study. All participants received placebo.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Adam Wanner</name_or_title>
      <organization>University of Miami</organization>
      <phone>3053010563</phone>
      <email>awanner@miami.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/NCT03270332
org study id: 20170552
nct id: NCT03270332
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of the present pilot study is to test the hypothesis that in patients with group
      1 pulmonary arterial hypertension (PAH) who are on regular oral pulmonary vasodilator
      therapy, inhaled albuterol causes transient pulmonary vasodilation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in Mean Pulmonary Artery Pressure (MPAP)
time frame: Baseline, up to 30 minutes after inhalation
description: Change in MPAP will be measured using echocardiogram
measure: Change in Pulmonary Vascular Resistance (PVR)
time frame: Baseline, up to 30 minutes after inhalation
description: Change in PVR will be measured using echocardiogram
arm group label: Albuterol followed by placebo
arm group type: Experimental
description: Participants in this group will receive albuterol first followed by Placebo on the next visit
arm group label: Placebo followed by albuterol
arm group type: Experimental
description: Participants in this group will receive placebo first followed by albuterol on the next visit
intervention type: Drug
intervention name: Albuterol
description: inhalation of 270μg albuterol through a spacer
arm group label: Albuterol followed by placebo
arm group label: Placebo followed by albuterol
intervention type: Drug
intervention name: Placebo
description: inhalation of placebo through a spacer
arm group label: Albuterol followed by placebo
arm group label: Placebo followed by albuterol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adam Wanner, MD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Adam Wanner
investigator title: Professor of Medicine
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
mesh term: Albuterol
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 