<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/NCT01705964</url>
  </required_header>
  <id_info>
    <org_study_id>Caperell-Epi-001</org_study_id>
    <nct_id>NCT01705964</nct_id>
  </id_info>
  <brief_title>Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation</brief_title>
  <official_title>Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Louisville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Louisville</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Project Aim: To determine if intramuscular epinephrine is an effective adjunct to inhaled&#xD;
      bronchodilators (β2 agonists) for children with severe asthma exacerbation.&#xD;
&#xD;
      Hypothesis: IM epinephrine is an efficacious adjunct to inhaled bronchodilators (β2 agonists)&#xD;
      for children with severe asthma exacerbation.&#xD;
&#xD;
      Intervention: Subjects will be randomly assigned (50% chance) to receive a weight based dose&#xD;
      of IM epinephrine 1:1000 or no adjunctive medication. The dose will be 0.2 mg for subjects&#xD;
      20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by&#xD;
      an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23&#xD;
      gauge one inch needle.&#xD;
&#xD;
      In addition to the study intervention, the standardized treatment pathway based on the&#xD;
      current asthma guidelines in use at the investigator's center will be utilized. This pathway&#xD;
      includes nebulized albuterol, ipratropium bromide, and systemic corticosteroids. The duration&#xD;
      and dosages of these other interventions will be administered at the discretion of the&#xD;
      treating provider.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15</measure>
    <time_frame>15 minutes after the study intervention</time_frame>
    <description>Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 15 minutes after the study intervention (t15).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disposition</measure>
    <time_frame>At the time a dispostion from the ED is completed (usually within 4 hours of the study intervention)</time_frame>
    <description>Disposition from the ED or rates of discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Percent of Predicted PEFR at t120</measure>
    <time_frame>120 minutes after the study intervention</time_frame>
    <description>Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 120 minutes after study intervention compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breaths Per Minute at t120</measure>
    <time_frame>breaths per minute 120 minutes after the study intervention</time_frame>
    <description>breaths per minute at t120 minutes compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate at t120</measure>
    <time_frame>up to 120 minutes after the study intervention</time_frame>
    <description>Heart rate at t120 minutes in beats per minute (BPM)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>IM epinephrine 1:1000</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IM epinephrine 1:1000</intervention_name>
    <description>IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.</description>
    <arm_group_label>IM epinephrine 1:1000</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.</description>
    <arm_group_label>No intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age greater than 6 years and less than 18 years&#xD;
&#xD;
          2. Pre-existing diagnosis of asthma&#xD;
&#xD;
          3. Presenting to the ED with an asthma exacerbation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of chronic lung or upper airway disease other than asthma&#xD;
&#xD;
          2. History significant, uncorrected congenital heart disease or cardiac arrhythmia&#xD;
&#xD;
          3. History of thyroid disease&#xD;
&#xD;
          4. Impending respiratory failure&#xD;
&#xD;
          5. Allergy to epinephrine&#xD;
&#xD;
          6. Pregnancy&#xD;
&#xD;
          7. PEFR&gt;60% of predicted and clinical asthma score less than 8&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kerry Caperell, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Louisville</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kosair Children's Hospital</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <results_first_submitted>May 6, 2020</results_first_submitted>
  <results_first_submitted_qc>June 12, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 6, 2021</results_first_posted>
  <last_update_submitted>June 12, 2021</last_update_submitted>
  <last_update_submitted_qc>June 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Louisville</investigator_affiliation>
    <investigator_full_name>Kerry Caperell</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Status asthmaticus</keyword>
  <keyword>Asthma exacerbation</keyword>
  <keyword>Epinephrine</keyword>
  <keyword>Adjunctive therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epinephrine</mesh_term>
  </intervention_browse>
  <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>October 16, 2012</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT01705964/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>IM Epinephrine 1:1000</title>
          <description>IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.&#xD;
IM epinephrine 1:1000: IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.</description>
        </group>
        <group group_id="P2">
          <title>No Intervention</title>
          <description>A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.&#xD;
No intervention: A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>IM Epinephrine 1:1000</title>
          <description>IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.&#xD;
IM epinephrine 1:1000: IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.</description>
        </group>
        <group group_id="B2">
          <title>No Intervention</title>
          <description>A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.&#xD;
No intervention: A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.</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="25"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="49"/>
          </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="25"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 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>
                  <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>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="10.00" spread="3.42"/>
                    <measurement group_id="B2" value="10.58" spread="2.76"/>
                    <measurement group_id="B3" value="10.29" spread="3.10"/>
                  </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="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="27"/>
                  </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="17"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </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="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15</title>
        <description>Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 15 minutes after the study intervention (t15).</description>
        <time_frame>15 minutes after the study intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IM Epinephrine 1:1000</title>
            <description>IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.&#xD;
IM epinephrine 1:1000: IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.</description>
          </group>
          <group group_id="O2">
            <title>No Intervention</title>
            <description>A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.&#xD;
No intervention: A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15</title>
          <description>Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 15 minutes after the study intervention (t15).</description>
          <units>percentage of predicted</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.56" spread="17.11"/>
                    <measurement group_id="O2" value="52.45" spread="13.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disposition</title>
        <description>Disposition from the ED or rates of discharge.</description>
        <time_frame>At the time a dispostion from the ED is completed (usually within 4 hours of the study intervention)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IM Epinephrine 1:1000</title>
            <description>IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.&#xD;
IM epinephrine 1:1000: IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.</description>
          </group>
          <group group_id="O2">
            <title>No Intervention</title>
            <description>A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.&#xD;
No intervention: A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.</description>
          </group>
        </group_list>
        <measure>
          <title>Disposition</title>
          <description>Disposition from the ED or rates of discharge.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Percent of Predicted PEFR at t120</title>
        <description>Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 120 minutes after study intervention compared to baseline</description>
        <time_frame>120 minutes after the study intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IM Epinephrine 1:1000</title>
            <description>IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.&#xD;
IM epinephrine 1:1000: IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.</description>
          </group>
          <group group_id="O2">
            <title>No Intervention</title>
            <description>A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.&#xD;
No intervention: A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Percent of Predicted PEFR at t120</title>
          <description>Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 120 minutes after study intervention compared to baseline</description>
          <units>percentage of PEFR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.51" spread="21.68"/>
                    <measurement group_id="O2" value="56.18" spread="13.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Breaths Per Minute at t120</title>
        <description>breaths per minute at t120 minutes compared to baseline</description>
        <time_frame>breaths per minute 120 minutes after the study intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IM Epinephrine 1:1000</title>
            <description>IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.&#xD;
IM epinephrine 1:1000: IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.</description>
          </group>
          <group group_id="O2">
            <title>No Intervention</title>
            <description>A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.&#xD;
No intervention: A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.</description>
          </group>
        </group_list>
        <measure>
          <title>Breaths Per Minute at t120</title>
          <description>breaths per minute at t120 minutes compared to baseline</description>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.29" spread="5.99"/>
                    <measurement group_id="O2" value="29.29" spread="7.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Heart Rate at t120</title>
        <description>Heart rate at t120 minutes in beats per minute (BPM)</description>
        <time_frame>up to 120 minutes after the study intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IM Epinephrine 1:1000</title>
            <description>IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.&#xD;
IM epinephrine 1:1000: IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.</description>
          </group>
          <group group_id="O2">
            <title>No Intervention</title>
            <description>A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.&#xD;
No intervention: A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate at t120</title>
          <description>Heart rate at t120 minutes in beats per minute (BPM)</description>
          <units>Beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="147.65" spread="13.91"/>
                    <measurement group_id="O2" value="142.29" spread="16.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 years 10 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>IM Epinephrine 1:1000</title>
          <description>IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.&#xD;
IM epinephrine 1:1000: IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.</description>
        </group>
        <group group_id="E2">
          <title>No Intervention</title>
          <description>A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.&#xD;
No intervention: A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.</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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </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>Dr. Kerry Caperell</name_or_title>
      <organization>University of Louisville</organization>
      <phone>502-629-7212</phone>
      <email>k0cape01@louisville.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/NCT01705964
org study id: Caperell-Epi-001
nct id: NCT01705964
lead sponsor: 
has dmc: No
Project Aim: To determine if intramuscular epinephrine is an effective adjunct to inhaled
      bronchodilators (β2 agonists) for children with severe asthma exacerbation.

      Hypothesis: IM epinephrine is an efficacious adjunct to inhaled bronchodilators (β2 agonists)
      for children with severe asthma exacerbation.

      Intervention: Subjects will be randomly assigned (50% chance) to receive a weight based dose
      of IM epinephrine 1:1000 or no adjunctive medication. The dose will be 0.2 mg for subjects
      20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by
      an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23
      gauge one inch needle.

      In addition to the study intervention, the standardized treatment pathway based on the
      current asthma guidelines in use at the investigator's center will be utilized. This pathway
      includes nebulized albuterol, ipratropium bromide, and systemic corticosteroids. The duration
      and dosages of these other interventions will be administered at the discretion of the
      treating provider.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15
time frame: 15 minutes after the study intervention
description: Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 15 minutes after the study intervention (t15).
measure: Disposition
time frame: At the time a dispostion from the ED is completed (usually within 4 hours of the study intervention)
description: Disposition from the ED or rates of discharge.
measure: Change in Percent of Predicted PEFR at t120
time frame: 120 minutes after the study intervention
description: Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 120 minutes after study intervention compared to baseline
measure: Breaths Per Minute at t120
time frame: breaths per minute 120 minutes after the study intervention
description: breaths per minute at t120 minutes compared to baseline
measure: Heart Rate at t120
time frame: up to 120 minutes after the study intervention
description: Heart rate at t120 minutes in beats per minute (BPM)
arm group label: IM epinephrine 1:1000
arm group type: Experimental
description: IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.
arm group label: No intervention
arm group type: Sham Comparator
description: A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.
intervention type: Drug
intervention name: IM epinephrine 1:1000
description: IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.
arm group label: IM epinephrine 1:1000
intervention type: Other
intervention name: No intervention
description: A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.
arm group label: No intervention
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: Kerry Caperell, MD
role: Principal Investigator
affiliation: University of Louisville
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Louisville
investigator full name: Kerry Caperell
investigator title: Assistant Professor of Pediatrics
mesh term: Asthma
mesh term: Epinephrine
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 