<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/NCT02192827</url>
  </required_header>
  <id_info>
    <org_study_id>647430-4</org_study_id>
    <nct_id>NCT02192827</nct_id>
  </id_info>
  <brief_title>Use of Dexamethasone in Pediatric Asthma Exacerbations</brief_title>
  <official_title>Single Dose Dexamethasone is as Effective as Two Doses in Mild to Moderate Pediatric Asthma Exacerbations in the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University at Buffalo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University at Buffalo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the efficacy of a single dose of dexamethasone vs.&#xD;
      two doses of dexamethasone in mild and moderate asthma exacerbations pediatric patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The emergency department (ED) physician will follow the standard asthma care path to manage a&#xD;
      pediatric asthma patient whether the patient meets study criteria or not. Patients' legal&#xD;
      guardian will be approached for consent if patient meets the study criteria. Once the consent&#xD;
      is obtained, the patient will be randomized into one of the two study groups according to a&#xD;
      randomization table generated by a statistician. The first group will receive a single dose&#xD;
      of dexamethasone sodium phosphate injection (0.6 mg/kg with max of 16 mg) mixed with&#xD;
      equivalent volume of cherry syrup given orally in the ED. The second group will receive a&#xD;
      first dose of dexamethasone with cherry syrup (also 0.6 mg/kg with max of 16 mg) in the ED,&#xD;
      and a second dose will be prescribed to the patient at home on the day following the ED&#xD;
      visit. This dose will be the same dosage of dexamethasone, but may be a pill or liquid form.&#xD;
      Patients will continue their previously prescribed asthma regimen and albuterol as needed.&#xD;
      Children who vomit the steroids in the ED will be re-dosed. Children who vomit the steroid a&#xD;
      second time will be excluded from the study.&#xD;
&#xD;
      2. Data collection. Demographic information such as age, race, duration of asthma symptoms,&#xD;
      number of previous hospitalizations, and current medication will be collected on an ED data&#xD;
      collection form. Pertinent exam findings such as patient's vital signs, pulse oximetry,&#xD;
      Pediatric asthma severity score (PAS), patient asthma severity self-assessment sheets (PSAS),&#xD;
      and ED treatment will also be collected on an ED data collection form.&#xD;
&#xD;
      After discharge from the ED, patients will be instructed to complete the PSAS on a daily&#xD;
      basis for 5 days. The data will be documented on a home patient self-assessment sheet by the&#xD;
      legal guardian. The investigators will train the legal guardians on how to complete the PSAS&#xD;
      in the ED.&#xD;
&#xD;
      3. Phone follow-up All patients will be contacted by phone by a research assistant 5 days&#xD;
      after the ED visit. Information collected during the phone interview will include PSAS,&#xD;
      unexpected visits to medical providers (ED, primary care or urgent care) for asthma symptoms,&#xD;
      school days missed due to asthma exacerbation, length of time symptoms persisted, compliance&#xD;
      with the recommended steroid regimen, vomiting, other side effects or medication&#xD;
      administration problems caused by the steroids.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Returning to Care Following Discharge From the Emergency Department</measure>
    <time_frame>5 days</time_frame>
    <description>The investigators will determine if each patient had any unscheduled visits to the emergency room, urgent care or primary care physician.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reported Number of Days Until Symptom Resolution</measure>
    <time_frame>5 days</time_frame>
    <description>Will determine number of days to symptom resolution, including missed school days.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Reported Side Effects Experienced by Participants</measure>
    <time_frame>5 days</time_frame>
    <description>The investigators will determine during phone follow up if patient experienced any side effects related to the Dexamethasone, including vomiting, mood swings, behavior changes, appetite changes, sweating or headache.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">318</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Single Dose Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Two Dose Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once in the Emergency Department (ED), followed by another dose of dexamethasone at home, which will be prescribed from the ED. The second dose will be the same dosage, but will be prescribed and may be pill or liquid form.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone Sodium Phosphate Injection</intervention_name>
    <arm_group_label>Single Dose Dexamethasone</arm_group_label>
    <arm_group_label>Two Dose Dexamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 2 to 20 years, from all race and ethnicity groups, with a known history&#xD;
             of asthma who present to the Emergency Department of Women and Children's Hospital of&#xD;
             Buffalo with an acute exacerbation of mild or moderate asthma are potentially eligible&#xD;
             for the study. Patients with severe asthma exacerbations will require intravenous&#xD;
             steroid therapy, therefore, they will not be enrolled in the study. The investigators&#xD;
             plan to enroll patients from winter of 2014 to fall 2016.&#xD;
&#xD;
        History of asthma is defined by physician diagnosis of at least 1 prior episode of wheezing&#xD;
        which responded to beta agonist medication.&#xD;
&#xD;
        Mild asthma is defined as: Pediatric Asthma Score (PAS) of 5 to 7; Moderate asthma is&#xD;
        defined as: PAS of 8 to 11; Severe asthma is defined as: PAS of 12 or more.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who have one of the following conditions will be excluded from the study: are&#xD;
             less than 2 years of age, have signs of severe exacerbation (Pediatric Asthma Score of&#xD;
             more than 11), have used oral steroids in the last 2 weeks, have chronic lung disease&#xD;
             (e.g., cystic fibrosis), have been given IV solumedrol, or vomit two doses of&#xD;
             dexamethasone in emergency department.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meghan E Martin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins All Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Women and Children's Hospital Of Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Akinbami LJ, Simon AE, Rossen LM. Changing Trends in Asthma Prevalence Among Children. Pediatrics. 2016 Jan;137(1):1-7. doi: 10.1542/peds.2015-2354. Epub 2015 Dec 28.</citation>
    <PMID>26712860</PMID>
  </reference>
  <reference>
    <citation>National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043. Erratum In: J Allergy Clin Immunol. 2008 Jun;121(6):1330.</citation>
    <PMID>17983880</PMID>
  </reference>
  <reference>
    <citation>Chapman KR, Verbeek PR, White JG, Rebuck AS. Effect of a short course of prednisone in the prevention of early relapse after the emergency room treatment of acute asthma. N Engl J Med. 1991 Mar 21;324(12):788-94. doi: 10.1056/NEJM199103213241202.</citation>
    <PMID>1997850</PMID>
  </reference>
  <reference>
    <citation>Rachelefsky G. Treating exacerbations of asthma in children: the role of systemic corticosteroids. Pediatrics. 2003 Aug;112(2):382-97. doi: 10.1542/peds.112.2.382.</citation>
    <PMID>12897291</PMID>
  </reference>
  <reference>
    <citation>Scarfone RJ, Fuchs SM, Nager AL, Shane SA. Controlled trial of oral prednisone in the emergency department treatment of children with acute asthma. Pediatrics. 1993 Oct;92(4):513-8.</citation>
    <PMID>8414819</PMID>
  </reference>
  <reference>
    <citation>Zoorob RJ, Cender D. A different look at corticosteroids. Am Fam Physician. 1998 Aug;58(2):443-50.</citation>
    <PMID>9713398</PMID>
  </reference>
  <reference>
    <citation>Cronin J, Kennedy U, McCoy S, An Fhaili SN, Crispino-O'Connell G, Hayden J, Wakai A, Walsh S, O'Sullivan R. Single dose oral dexamethasone versus multi-dose prednisolone in the treatment of acute exacerbations of asthma in children who attend the emergency department: study protocol for a randomized controlled trial. Trials. 2012 Aug 21;13:141. doi: 10.1186/1745-6215-13-141.</citation>
    <PMID>22909281</PMID>
  </reference>
  <reference>
    <citation>Karaman M, Ilhan AE, Dereci G, Tek A. Determination of optimum dosage of intraoperative single dose dexamethasone in pediatric tonsillectomy and adenotonsillectomy. Int J Pediatr Otorhinolaryngol. 2009 Nov;73(11):1513-5. doi: 10.1016/j.ijporl.2009.06.001. Epub 2009 Jul 10.</citation>
    <PMID>19801100</PMID>
  </reference>
  <reference>
    <citation>Qureshi F, Zaritsky A, Poirier MP. Comparative efficacy of oral dexamethasone versus oral prednisone in acute pediatric asthma. J Pediatr. 2001 Jul;139(1):20-6. doi: 10.1067/mpd.2001.115021.</citation>
    <PMID>11445789</PMID>
  </reference>
  <reference>
    <citation>Greenberg RA, Kerby G, Roosevelt GE. A comparison of oral dexamethasone with oral prednisone in pediatric asthma exacerbations treated in the emergency department. Clin Pediatr (Phila). 2008 Oct;47(8):817-23. doi: 10.1177/0009922808316988. Epub 2008 May 8.</citation>
    <PMID>18467673</PMID>
  </reference>
  <reference>
    <citation>Keeney GE, Gray MP, Morrison AK, Levas MN, Kessler EA, Hill GD, Gorelick MH, Jackson JL. Dexamethasone for acute asthma exacerbations in children: a meta-analysis. Pediatrics. 2014 Mar;133(3):493-9. doi: 10.1542/peds.2013-2273. Epub 2014 Feb 10.</citation>
    <PMID>24515516</PMID>
  </reference>
  <reference>
    <citation>Kelly CS, Andersen CL, Pestian JP, Wenger AD, Finch AB, Strope GL, Luckstead EF. Improved outcomes for hospitalized asthmatic children using a clinical pathway. Ann Allergy Asthma Immunol. 2000 May;84(5):509-16. doi: 10.1016/S1081-1206(10)62514-8.</citation>
    <PMID>10831004</PMID>
  </reference>
  <reference>
    <citation>Chang AB, Clark R, Sloots TP, Stone DG, Petsky HL, Thearle D, Champion AA, Wheeler C, Acworth JP. A 5- versus 3-day course of oral corticosteroids for children with asthma exacerbations who are not hospitalised: a randomised controlled trial. Med J Aust. 2008 Sep 15;189(6):306-10. doi: 10.5694/j.1326-5377.2008.tb02046.x.</citation>
    <PMID>18803532</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <results_first_submitted>September 23, 2020</results_first_submitted>
  <results_first_submitted_qc>March 29, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 30, 2023</results_first_posted>
  <last_update_submitted>March 29, 2023</last_update_submitted>
  <last_update_submitted_qc>March 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University at Buffalo</investigator_affiliation>
    <investigator_full_name>Meghan Martin</investigator_full_name>
    <investigator_title>Pediatric Emergency Medicine Attending Physician</investigator_title>
  </responsible_party>
  <keyword>Pediatric</keyword>
  <keyword>Asthma</keyword>
  <keyword>Exacerbation</keyword>
  <keyword>Dexamethasone</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>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Dexamethasone 21-phosphate</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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>November 9, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT02192827/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 9, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT02192827/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients presenting with asthma symptoms to a single pediatric emergency department</recruitment_details>
      <pre_assignment_details>Excluded 10 Patients:&#xD;
Previously enrolled into the study: 2 Admitted to the PICU (pediatric intensive care unit): 5 Required IV steroids in the Emergency Dept: 1 Steroid use within the last 2 weeks: 1 Excessive vomiting in the Emergency Dept: 1</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Single Dose Dexamethasone</title>
          <description>0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once&#xD;
Dexamethasone Sodium Phosphate Injection</description>
        </group>
        <group group_id="P2">
          <title>Two Dose Dexamethasone</title>
          <description>0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once in the Emergency Department (ED), followed by another dose of dexamethasone at home, which will be prescribed from the ED. The second dose will be the same dosage, but will be prescribed and may be pill or liquid form.&#xD;
Dexamethasone Sodium Phosphate Injection</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="154"/>
                <participants group_id="P2" count="154"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="116"/>
                <participants group_id="P2" count="116"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Given additional steroids with admission</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Single Dose Dexamethasone</title>
          <description>0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once&#xD;
Dexamethasone Sodium Phosphate Injection</description>
        </group>
        <group group_id="B2">
          <title>Two Dose Dexamethasone</title>
          <description>0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once in the Emergency Department (ED), followed by another dose of dexamethasone at home, which will be prescribed from the ED. The second dose will be the same dosage, but will be prescribed and may be pill or liquid form.&#xD;
Dexamethasone Sodium Phosphate Injection</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="116"/>
            <count group_id="B2" value="116"/>
            <count group_id="B3" value="232"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="116"/>
                    <count group_id="B2" value="116"/>
                    <count group_id="B3" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.8" spread="3.9"/>
                    <measurement group_id="B2" value="8.2" spread="4.4"/>
                    <measurement group_id="B3" value="7.5" spread="4.2"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="116"/>
                    <count group_id="B2" value="116"/>
                    <count group_id="B3" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="140"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="116"/>
                    <count group_id="B2" value="116"/>
                    <count group_id="B3" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>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="61"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="61"/>
                  </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="21"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tobacco exposure in home</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="116"/>
                    <count group_id="B2" value="116"/>
                    <count group_id="B3" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of days with symptoms</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="116"/>
                    <count group_id="B2" value="116"/>
                    <count group_id="B3" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.6" spread="9.7"/>
                    <measurement group_id="B2" value="3.1" spread="7.5"/>
                    <measurement group_id="B3" value="3.3" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current use of asthma controller medication</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="116"/>
                    <count group_id="B2" value="116"/>
                    <count group_id="B3" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of previous hospital admissions</title>
          <units>admissions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="116"/>
                    <count group_id="B2" value="116"/>
                    <count group_id="B3" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.4" spread="1.9"/>
                    <measurement group_id="B2" value="1.2" spread="2.5"/>
                    <measurement group_id="B3" value="1.3" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pediatric Asthma Score before albuterol administered</title>
          <description>Pediatric asthma Scores (based on respiratory rate by age, oxygen requirements, auscultation, retractions, dyspnea):&#xD;
5-7 Mild exacerbation 8-11 Moderate exacerbation 12-15 Severe exacerbation</description>
          <population>PAS scores not available for all participants</population>
          <units>PAS score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="106"/>
                    <count group_id="B2" value="107"/>
                    <count group_id="B3" value="213"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.2" spread="1.8"/>
                    <measurement group_id="B2" value="6.9" spread="1.5"/>
                    <measurement group_id="B3" value="7.1" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Returning to Care Following Discharge From the Emergency Department</title>
        <description>The investigators will determine if each patient had any unscheduled visits to the emergency room, urgent care or primary care physician.</description>
        <time_frame>5 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Dose Dexamethasone</title>
            <description>0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once&#xD;
Dexamethasone Sodium Phosphate Injection</description>
          </group>
          <group group_id="O2">
            <title>Two Dose Dexamethasone</title>
            <description>0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once in the Emergency Department (ED), followed by another dose of dexamethasone at home, which will be prescribed from the ED. The second dose will be the same dosage, but will be prescribed and may be pill or liquid form.&#xD;
Dexamethasone Sodium Phosphate Injection</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Returning to Care Following Discharge From the Emergency Department</title>
          <description>The investigators will determine if each patient had any unscheduled visits to the emergency room, urgent care or primary care physician.</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="116"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reported Number of Days Until Symptom Resolution</title>
        <description>Will determine number of days to symptom resolution, including missed school days.</description>
        <time_frame>5 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Dose Dexamethasone</title>
            <description>0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once&#xD;
Dexamethasone Sodium Phosphate Injection</description>
          </group>
          <group group_id="O2">
            <title>Two Dose Dexamethasone</title>
            <description>0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once in the Emergency Department (ED), followed by another dose of dexamethasone at home, which will be prescribed from the ED. The second dose will be the same dosage, but will be prescribed and may be pill or liquid form.&#xD;
Dexamethasone Sodium Phosphate Injection</description>
          </group>
        </group_list>
        <measure>
          <title>Reported Number of Days Until Symptom Resolution</title>
          <description>Will determine number of days to symptom resolution, including missed school days.</description>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="3.5"/>
                    <measurement group_id="O2" value="2.5" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Reported Side Effects Experienced by Participants</title>
        <description>The investigators will determine during phone follow up if patient experienced any side effects related to the Dexamethasone, including vomiting, mood swings, behavior changes, appetite changes, sweating or headache.</description>
        <time_frame>5 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Dose Dexamethasone</title>
            <description>0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once&#xD;
Dexamethasone Sodium Phosphate Injection</description>
          </group>
          <group group_id="O2">
            <title>Two Dose Dexamethasone</title>
            <description>0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once in the Emergency Department (ED), followed by another dose of dexamethasone at home, which will be prescribed from the ED. The second dose will be the same dosage, but will be prescribed and may be pill or liquid form.&#xD;
Dexamethasone Sodium Phosphate Injection</description>
          </group>
        </group_list>
        <measure>
          <title>Reported Side Effects Experienced by Participants</title>
          <description>The investigators will determine during phone follow up if patient experienced any side effects related to the Dexamethasone, including vomiting, mood swings, behavior changes, appetite changes, sweating or headache.</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="116"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No side effects</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                    <measurement group_id="O2" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decreased Appetite</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difficulty Sleeping</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mood swings/Agitation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiple</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Single Dose Dexamethasone</title>
          <description>This group was the standard arm and received one single dose of dexamethasone in the Emergency department</description>
        </group>
        <group group_id="E2">
          <title>Two Doses of Dexamethasone</title>
          <description>This group was the intervention group and received a dose of dexma</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="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <description>Reported decrease in appetite</description>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Difficulty sleeping</sub_title>
                <description>Reported difficulty sleeping</description>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Moodswing/Agitation</sub_title>
                <description>Reported mood swings/agitation</description>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="116"/>
              </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>Meghan Martin</name_or_title>
      <organization>Johns Hopkins all childrens hospital</organization>
      <phone>9417373107</phone>
      <email>mmart163@jhmi.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/NCT02192827
org study id: 647430-4
nct id: NCT02192827
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to compare the efficacy of a single dose of dexamethasone vs.
      two doses of dexamethasone in mild and moderate asthma exacerbations pediatric patients.
The emergency department (ED) physician will follow the standard asthma care path to manage a
      pediatric asthma patient whether the patient meets study criteria or not. Patients' legal
      guardian will be approached for consent if patient meets the study criteria. Once the consent
      is obtained, the patient will be randomized into one of the two study groups according to a
      randomization table generated by a statistician. The first group will receive a single dose
      of dexamethasone sodium phosphate injection (0.6 mg/kg with max of 16 mg) mixed with
      equivalent volume of cherry syrup given orally in the ED. The second group will receive a
      first dose of dexamethasone with cherry syrup (also 0.6 mg/kg with max of 16 mg) in the ED,
      and a second dose will be prescribed to the patient at home on the day following the ED
      visit. This dose will be the same dosage of dexamethasone, but may be a pill or liquid form.
      Patients will continue their previously prescribed asthma regimen and albuterol as needed.
      Children who vomit the steroids in the ED will be re-dosed. Children who vomit the steroid a
      second time will be excluded from the study.

      2. Data collection. Demographic information such as age, race, duration of asthma symptoms,
      number of previous hospitalizations, and current medication will be collected on an ED data
      collection form. Pertinent exam findings such as patient's vital signs, pulse oximetry,
      Pediatric asthma severity score (PAS), patient asthma severity self-assessment sheets (PSAS),
      and ED treatment will also be collected on an ED data collection form.

      After discharge from the ED, patients will be instructed to complete the PSAS on a daily
      basis for 5 days. The data will be documented on a home patient self-assessment sheet by the
      legal guardian. The investigators will train the legal guardians on how to complete the PSAS
      in the ED.

      3. Phone follow-up All patients will be contacted by phone by a research assistant 5 days
      after the ED visit. Information collected during the phone interview will include PSAS,
      unexpected visits to medical providers (ED, primary care or urgent care) for asthma symptoms,
      school days missed due to asthma exacerbation, length of time symptoms persisted, compliance
      with the recommended steroid regimen, vomiting, other side effects or medication
      administration problems caused by the steroids.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Returning to Care Following Discharge From the Emergency Department
time frame: 5 days
description: The investigators will determine if each patient had any unscheduled visits to the emergency room, urgent care or primary care physician.
measure: Reported Number of Days Until Symptom Resolution
time frame: 5 days
description: Will determine number of days to symptom resolution, including missed school days.
measure: Reported Side Effects Experienced by Participants
time frame: 5 days
description: The investigators will determine during phone follow up if patient experienced any side effects related to the Dexamethasone, including vomiting, mood swings, behavior changes, appetite changes, sweating or headache.
arm group label: Single Dose Dexamethasone
arm group type: Experimental
description: 0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once
arm group label: Two Dose Dexamethasone
arm group type: Experimental
description: 0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once in the Emergency Department (ED), followed by another dose of dexamethasone at home, which will be prescribed from the ED. The second dose will be the same dosage, but will be prescribed and may be pill or liquid form.
intervention type: Drug
intervention name: Dexamethasone Sodium Phosphate Injection
arm group label: Single Dose Dexamethasone
arm group label: Two Dose Dexamethasone
criteria: 
gender: All
minimum age: 2 Years
maximum age: 20 Years
healthy volunteers: No
last name: Meghan E Martin, MD
role: Principal Investigator
affiliation: Johns Hopkins All Children's Hospital
facility: 
country: United States
citation: Akinbami LJ, Simon AE, Rossen LM. Changing Trends in Asthma Prevalence Among Children. Pediatrics. 2016 Jan;137(1):1-7. doi: 10.1542/peds.2015-2354. Epub 2015 Dec 28.
PMID: 26712860
citation: National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043. Erratum In: J Allergy Clin Immunol. 2008 Jun;121(6):1330.
PMID: 17983880
citation: Chapman KR, Verbeek PR, White JG, Rebuck AS. Effect of a short course of prednisone in the prevention of early relapse after the emergency room treatment of acute asthma. N Engl J Med. 1991 Mar 21;324(12):788-94. doi: 10.1056/NEJM199103213241202.
PMID: 1997850
citation: Rachelefsky G. Treating exacerbations of asthma in children: the role of systemic corticosteroids. Pediatrics. 2003 Aug;112(2):382-97. doi: 10.1542/peds.112.2.382.
PMID: 12897291
citation: Scarfone RJ, Fuchs SM, Nager AL, Shane SA. Controlled trial of oral prednisone in the emergency department treatment of children with acute asthma. Pediatrics. 1993 Oct;92(4):513-8.
PMID: 8414819
citation: Zoorob RJ, Cender D. A different look at corticosteroids. Am Fam Physician. 1998 Aug;58(2):443-50.
PMID: 9713398
citation: Cronin J, Kennedy U, McCoy S, An Fhaili SN, Crispino-O'Connell G, Hayden J, Wakai A, Walsh S, O'Sullivan R. Single dose oral dexamethasone versus multi-dose prednisolone in the treatment of acute exacerbations of asthma in children who attend the emergency department: study protocol for a randomized controlled trial. Trials. 2012 Aug 21;13:141. doi: 10.1186/1745-6215-13-141.
PMID: 22909281
citation: Karaman M, Ilhan AE, Dereci G, Tek A. Determination of optimum dosage of intraoperative single dose dexamethasone in pediatric tonsillectomy and adenotonsillectomy. Int J Pediatr Otorhinolaryngol. 2009 Nov;73(11):1513-5. doi: 10.1016/j.ijporl.2009.06.001. Epub 2009 Jul 10.
PMID: 19801100
citation: Qureshi F, Zaritsky A, Poirier MP. Comparative efficacy of oral dexamethasone versus oral prednisone in acute pediatric asthma. J Pediatr. 2001 Jul;139(1):20-6. doi: 10.1067/mpd.2001.115021.
PMID: 11445789
citation: Greenberg RA, Kerby G, Roosevelt GE. A comparison of oral dexamethasone with oral prednisone in pediatric asthma exacerbations treated in the emergency department. Clin Pediatr (Phila). 2008 Oct;47(8):817-23. doi: 10.1177/0009922808316988. Epub 2008 May 8.
PMID: 18467673
citation: Keeney GE, Gray MP, Morrison AK, Levas MN, Kessler EA, Hill GD, Gorelick MH, Jackson JL. Dexamethasone for acute asthma exacerbations in children: a meta-analysis. Pediatrics. 2014 Mar;133(3):493-9. doi: 10.1542/peds.2013-2273. Epub 2014 Feb 10.
PMID: 24515516
citation: Kelly CS, Andersen CL, Pestian JP, Wenger AD, Finch AB, Strope GL, Luckstead EF. Improved outcomes for hospitalized asthmatic children using a clinical pathway. Ann Allergy Asthma Immunol. 2000 May;84(5):509-16. doi: 10.1016/S1081-1206(10)62514-8.
PMID: 10831004
citation: Chang AB, Clark R, Sloots TP, Stone DG, Petsky HL, Thearle D, Champion AA, Wheeler C, Acworth JP. A 5- versus 3-day course of oral corticosteroids for children with asthma exacerbations who are not hospitalised: a randomised controlled trial. Med J Aust. 2008 Sep 15;189(6):306-10. doi: 10.5694/j.1326-5377.2008.tb02046.x.
PMID: 18803532
responsible party type: Principal Investigator
investigator affiliation: University at Buffalo
investigator full name: Meghan Martin
investigator title: Pediatric Emergency Medicine Attending Physician
mesh term: Asthma
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Dexamethasone 21-phosphate
mesh term: BB 1101
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 