<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT03029156</url>
  </required_header>
  <id_info>
    <org_study_id>11643</org_study_id>
    <nct_id>NCT03029156</nct_id>
  </id_info>
  <brief_title>Effectiveness of the Aeroneb in Acute Severe Asthma</brief_title>
  <official_title>Effectiveness of the Aeroneb Compared to a Jet Nebulizer Fort the Delivery of Bronchodilator Therapy of Acute Severe Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tufts Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tufts Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: The bronchodilator therapy is an essential component of the management of asthma&#xD;
      exacerbation. The delivery of bronchodilators to the lungs in asthma exacerbations is usually&#xD;
      achieved through nebulization (creating small particles to be inhaled). The commonly used&#xD;
      nebulizer device is a small volume jet nebulizer which has not been consistently reliable in&#xD;
      delivering bronchodilator therapy. The Aeroneb nebulizer device is a FDA approved device&#xD;
      which produces consistently respirable sized particles which could potentially result in&#xD;
      better bronchodilator effect than the standard jet nebulizer.&#xD;
&#xD;
      Aim: To study whether the Aeroneb nebulizer is more effective than a small volume jet&#xD;
      nebulizer in delivering bronchodilators during a severe asthma exacerbation.&#xD;
&#xD;
      Experimental design: Patients will be randomized (like a flip of a coin) to receive&#xD;
      bronchodilator therapy as per the emergency room protocol either via small volume jet&#xD;
      nebulizer or Aeroneb nebulizer.&#xD;
&#xD;
      Subjects: Adult patients between age of 18 and 55 years who present to the emergency room&#xD;
      with severe asthma exacerbation with peak expiratory flow rate &lt;50% of predicted.&#xD;
&#xD;
      Study procedure: When enrolled in the study and after randomization, we will then collect&#xD;
      data that is standard for the hospital like heart rate, blood pressure and breathing indices&#xD;
      and also some non-routine things like some scoring scales for shortness of breath and serial&#xD;
      measurements of peak expiratory flow rate. We anticipate that the Aeroneb device will be more&#xD;
      effective in delivering bronchodilator medication and thus more effective in managing asthma&#xD;
      exacerbations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Patients presenting with acute severe asthma exacerbations to the emergency room will be&#xD;
           screened by the PI, co-investigator or research coordinator to determine their&#xD;
           eligibility based on the inclusion and exclusion criteria.&#xD;
&#xD;
        -  Clinically indicated treatment must not be delayed for a research-related reason so&#xD;
           patients will still be eligible for enrollment after receiving initial bronchodilator&#xD;
           therapy as long as their PEFR remains &lt;50% of predicted and enrollment occurs within 90&#xD;
           minutes of the ER arrival time.&#xD;
&#xD;
        -  The initial part of the consent process will cover the essential elements of the&#xD;
           informed consent in a concise manner to ensure a timely process&#xD;
&#xD;
        -  Eligible patients will be randomized using the concealed envelope method to either the&#xD;
           intervention arm or the control arm. The randomization should take place within 90&#xD;
           minutes of ER arrival, however, every effort will be made to enroll the patient as soon&#xD;
           as possible; patients will be enrolled as long as their PEFR is less than 50% of&#xD;
           predicted regardless of the number of bronchodilator treatments they received prior to&#xD;
           randomization.&#xD;
&#xD;
        -  The assignment will be blinded to the recording investigator and the treating physician&#xD;
           but not to the patient or the nurse or respiratory therapist who is administering the&#xD;
           nebulization. In order to avoid any delay in administering the treatments, the sets of&#xD;
           Aeroneb nebulizer and small volume jet nebulizer will be stored in identical boxes and&#xD;
           will be readily available in the ER.&#xD;
&#xD;
      In order to blind the treating physician and the recording investigator, a sign &quot;treatment in&#xD;
      progress&quot; will be displayed at the outdoor of the ER room when the patient is getting the&#xD;
      bronchodilator treatment. The nebulizer devices will be placed in the box between the&#xD;
      bronchodilator treatment sessions. The physician and the recording investigator will be asked&#xD;
      if possible to see the patients only when the sign is taken off the outdoor.&#xD;
&#xD;
        -  Once assigned, all the bronchodilator treatments in the ER will be administered using&#xD;
           the nebulizer device assigned to that patient.&#xD;
&#xD;
        -  The Peak flow and FEV1 will be measured using Spirometer (micro I). Both values will be&#xD;
           obtained through the same exhalation maneuver.&#xD;
&#xD;
        -  Patient will be treated and managed according to the asthma ER adult protocol or as&#xD;
           directed by the ER physician who is in charge of patient's care&#xD;
&#xD;
        -  After the study procedures have been performed and the subject is determined to be in&#xD;
           stable condition and have the capacity to make medical decisions, the investigator will&#xD;
           approach the subject again and review all the elements of the ICF again with the&#xD;
           subject. The collected data will be used only if the subject signs both parts of the&#xD;
           informed consent.&#xD;
&#xD;
        -  Within two weeks of the subject participation, the research team will conduct a phone&#xD;
           interview with the subject to obtain their feedback on the study procedures and mainly&#xD;
           on the informed consent process. The phone interview questionnaire is included in the&#xD;
           supplement&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2015</start_date>
  <completion_date type="Actual">August 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <phase>N/A</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>Percentage Change in Mean of Peak Expiratory Flow Rate (PEFR) Percentage of Predicted Baseline at 30 Minutes After the Initial Bronchodilator Treatment</measure>
    <time_frame>30 minutes</time_frame>
    <description>Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage Change in the PEFR Percentage of Predicted Baseline to Disposition</measure>
    <time_frame>Initial bronchodilator treatment to disposition, an average of 4 hours</time_frame>
    <description>Change in the PEFR percent predicted from the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Change in the Forced Expiratory Volume (FEV1) Percentage of Predicted Baseline to Disposition</measure>
    <time_frame>initial bronchodilator treatment to disposition, an average of 4 hours</time_frame>
    <description>Forced expiratory volume refers to the volume of air that an individual can exhale during a forced breath in 1 second.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Borg-Dyspnea Score From Baseline to Disposition</measure>
    <time_frame>initial bronchodilator treatment to disposition, an average of 4 hours</time_frame>
    <description>The Borg-Dyspnea score measures an individual's effort, exertion, breathlessness and fatigue during physical work. This scale ranges from 6-20 with 6 representing no exertion at all and 20 representing maximal exertion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Heart Rate Baseline to Disposition</measure>
    <time_frame>The initial bronchodilator treatment to to disposition, an average of 4 hours</time_frame>
    <description>Change in the heart rate at baseline after the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay in the ER</measure>
    <time_frame>Length of stay in the ER - up to one day</time_frame>
    <description>Total length from admission to discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Requiring Hospitalization</measure>
    <time_frame>Length of stay in the ER - up to one day</time_frame>
    <description>Total amount of patients requiring hospitalization after ER admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Total Dose of Albuterol Used in Each Group During ED Stay</measure>
    <time_frame>Length of stay in the ER - up to one day</time_frame>
    <description>Albuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The Total Dose of Ipratropium Used in Each Group During ED Stay</measure>
    <time_frame>Length of stay in the ER - up to one day</time_frame>
    <description>Ipratropium is used to prevent wheezing, shortness of breath, coughing and chest tightness in people with chronic obstructive pulmonary disease, chronic bronchitis, and emphysema. It is a bronchodilator which relaxes and opens the air passages to the lungs to make breathing easier.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Asthma Exacerbation</condition>
  <arm_group>
    <arm_group_label>Small volume jet nebulizer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aeroneb nebulizer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aeroneb nebulizer</intervention_name>
    <description>The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.&#xD;
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).</description>
    <arm_group_label>Aeroneb nebulizer</arm_group_label>
    <other_name>Vibrating mesh nebulizer</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Small volume jet nebulizer</intervention_name>
    <description>The bronchodilators will be administered via small volume jet nebulizer</description>
    <arm_group_label>Small volume jet nebulizer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute asthma exacerbations presenting to the emergency room&#xD;
&#xD;
          -  Peak expiratory flow rate at presentation &lt;40% of predicted&#xD;
&#xD;
          -  Enrolment within 90 minutes of the arrival to the ER&#xD;
&#xD;
          -  Age 18-55 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Clinical evidence to suggest a non-asthmatic cause of bronchospasm as determined by&#xD;
             the treating physician&#xD;
&#xD;
          -  Clinical evidence of acute coronary syndrome&#xD;
&#xD;
          -  Respiratory failure requiring mechanical ventilation either invasive or non-invasive&#xD;
&#xD;
          -  Tachyarrhythmia other than sinus&#xD;
&#xD;
          -  Agitated or uncooperative&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicholas S Hill, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tufts Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>McFadden ER Jr. Acute severe asthma. Am J Respir Crit Care Med. 2003 Oct 1;168(7):740-59. doi: 10.1164/rccm.200208-902SO.</citation>
    <PMID>14522812</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>Rodrigo G, Rodrigo C. A new index for early prediction of hospitalization in patients with acute asthma. Am J Emerg Med. 1997 Jan;15(1):8-13. doi: 10.1016/s0735-6757(97)90039-5.</citation>
    <PMID>9002561</PMID>
  </reference>
  <reference>
    <citation>Rodrigo G, Rodrigo C. Early prediction of poor response in acute asthma patients in the emergency department. Chest. 1998 Oct;114(4):1016-21. doi: 10.1378/chest.114.4.1016.</citation>
    <PMID>9792570</PMID>
  </reference>
  <reference>
    <citation>Piovesan DM, Menegotto DM, Kang S, Franciscatto E, Millan T, Hoffmann C, Pasin LR, Fischer J, Barreto SS, Dalcin Pde T. Early prognosis of acute asthma in the emergency room. J Bras Pneumol. 2006 Jan-Feb;32(1):1-9. doi: 10.1590/s1806-37132006000100004. English, Portuguese.</citation>
    <PMID>17273562</PMID>
  </reference>
  <reference>
    <citation>Ari A, Atalay OT, Harwood R, Sheard MM, Aljamhan EA, Fink JB. Influence of nebulizer type, position, and bias flow on aerosol drug delivery in simulated pediatric and adult lung models during mechanical ventilation. Respir Care. 2010 Jul;55(7):845-51.</citation>
    <PMID>20587095</PMID>
  </reference>
  <reference>
    <citation>Galindo-Filho VC, Ramos ME, Rattes CS, Barbosa AK, Brandao DC, Brandao SC, Fink JB, de Andrade AD. Radioaerosol Pulmonary Deposition Using Mesh and Jet Nebulizers During Noninvasive Ventilation in Healthy Subjects. Respir Care. 2015 Sep;60(9):1238-46. doi: 10.4187/respcare.03667. Epub 2015 Jun 23.</citation>
    <PMID>26106207</PMID>
  </reference>
  <reference>
    <citation>Alvine GF, Rodgers P, Fitzsimmons KM, Ahrens RC. Disposable jet nebulizers. How reliable are they? Chest. 1992 Feb;101(2):316-9. doi: 10.1378/chest.101.2.316.</citation>
    <PMID>1735247</PMID>
  </reference>
  <reference>
    <citation>Borg G. Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med. 1970;2(2):92-8. No abstract available.</citation>
    <PMID>5523831</PMID>
  </reference>
  <reference>
    <citation>Patrick W, Webster K, Ludwig L, Roberts D, Wiebe P, Younes M. Noninvasive positive-pressure ventilation in acute respiratory distress without prior chronic respiratory failure. Am J Respir Crit Care Med. 1996 Mar;153(3):1005-11. doi: 10.1164/ajrccm.153.3.8630538.</citation>
    <PMID>8630538</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 18, 2016</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <results_first_submitted>February 2, 2023</results_first_submitted>
  <results_first_submitted_qc>May 18, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 19, 2023</results_first_posted>
  <last_update_submitted>May 18, 2023</last_update_submitted>
  <last_update_submitted_qc>May 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Asthma</keyword>
  <keyword>Aeroneb</keyword>
  <keyword>Aerogen</keyword>
  <keyword>Bronchodilator</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Status Asthmaticus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 20, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03029156/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Small Volume Jet Nebulizer</title>
          <description>Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The bronchodilators will be administered via small volume jet nebulizer</description>
        </group>
        <group group_id="P2">
          <title>Aeroneb Nebulizer</title>
          <description>Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.&#xD;
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="16"/>
              </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>Small Volume Jet Nebulizer</title>
          <description>Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The bronchodilators will be administered via small volume jet nebulizer</description>
        </group>
        <group group_id="B2">
          <title>Aeroneb Nebulizer</title>
          <description>Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.&#xD;
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).</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="15"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="31"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.4" spread="8.46"/>
                    <measurement group_id="B2" value="39.9" spread="9.05"/>
                    <measurement group_id="B3" value="36" spread="8.75"/>
                  </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="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/Ethnicity</title>
              <category_list>
                <category>
                  <title>African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage Change in Mean of Peak Expiratory Flow Rate (PEFR) Percentage of Predicted Baseline at 30 Minutes After the Initial Bronchodilator Treatment</title>
        <description>Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration.</description>
        <time_frame>30 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Small Volume Jet Nebulizer</title>
            <description>Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The bronchodilators will be administered via small volume jet nebulizer</description>
          </group>
          <group group_id="O2">
            <title>Aeroneb Nebulizer</title>
            <description>Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.&#xD;
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change in Mean of Peak Expiratory Flow Rate (PEFR) Percentage of Predicted Baseline at 30 Minutes After the Initial Bronchodilator Treatment</title>
          <description>Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration.</description>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1" spread="18.01"/>
                    <measurement group_id="O2" value="12.9" spread="13.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change in the PEFR Percentage of Predicted Baseline to Disposition</title>
        <description>Change in the PEFR percent predicted from the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group.</description>
        <time_frame>Initial bronchodilator treatment to disposition, an average of 4 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Small Volume Jet Nebulizer</title>
            <description>Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The bronchodilators will be administered via small volume jet nebulizer</description>
          </group>
          <group group_id="O2">
            <title>Aeroneb Nebulizer</title>
            <description>Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.&#xD;
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change in the PEFR Percentage of Predicted Baseline to Disposition</title>
          <description>Change in the PEFR percent predicted from the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group.</description>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.3" spread="15.15"/>
                    <measurement group_id="O2" value="14.4" spread="14.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change in the Forced Expiratory Volume (FEV1) Percentage of Predicted Baseline to Disposition</title>
        <description>Forced expiratory volume refers to the volume of air that an individual can exhale during a forced breath in 1 second.</description>
        <time_frame>initial bronchodilator treatment to disposition, an average of 4 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Small Volume Jet Nebulizer</title>
            <description>Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The bronchodilators will be administered via small volume jet nebulizer</description>
          </group>
          <group group_id="O2">
            <title>Aeroneb Nebulizer</title>
            <description>Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.&#xD;
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change in the Forced Expiratory Volume (FEV1) Percentage of Predicted Baseline to Disposition</title>
          <description>Forced expiratory volume refers to the volume of air that an individual can exhale during a forced breath in 1 second.</description>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.1" spread="13.05"/>
                    <measurement group_id="O2" value="8.0" spread="8.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Borg-Dyspnea Score From Baseline to Disposition</title>
        <description>The Borg-Dyspnea score measures an individual's effort, exertion, breathlessness and fatigue during physical work. This scale ranges from 6-20 with 6 representing no exertion at all and 20 representing maximal exertion.</description>
        <time_frame>initial bronchodilator treatment to disposition, an average of 4 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Small Volume Jet Nebulizer</title>
            <description>Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The bronchodilators will be administered via small volume jet nebulizer</description>
          </group>
          <group group_id="O2">
            <title>Aeroneb Nebulizer</title>
            <description>Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.&#xD;
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Borg-Dyspnea Score From Baseline to Disposition</title>
          <description>The Borg-Dyspnea score measures an individual's effort, exertion, breathlessness and fatigue during physical work. This scale ranges from 6-20 with 6 representing no exertion at all and 20 representing maximal exertion.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.44" spread="0.12"/>
                    <measurement group_id="O2" value="3.15" spread="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Heart Rate Baseline to Disposition</title>
        <description>Change in the heart rate at baseline after the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group.</description>
        <time_frame>The initial bronchodilator treatment to to disposition, an average of 4 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Small Volume Jet Nebulizer</title>
            <description>Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The bronchodilators will be administered via small volume jet nebulizer</description>
          </group>
          <group group_id="O2">
            <title>Aeroneb Nebulizer</title>
            <description>Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.&#xD;
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Heart Rate Baseline to Disposition</title>
          <description>Change in the heart rate at baseline after the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group.</description>
          <units>Change in heart rate (beats/min)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="3"/>
                    <measurement group_id="O2" value="1" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Stay in the ER</title>
        <description>Total length from admission to discharge.</description>
        <time_frame>Length of stay in the ER - up to one day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Small Volume Jet Nebulizer</title>
            <description>Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The bronchodilators will be administered via small volume jet nebulizer</description>
          </group>
          <group group_id="O2">
            <title>Aeroneb Nebulizer</title>
            <description>Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.&#xD;
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Stay in the ER</title>
          <description>Total length from admission to discharge.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="272.3" spread="123.74"/>
                    <measurement group_id="O2" value="245.3" spread="139.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Requiring Hospitalization</title>
        <description>Total amount of patients requiring hospitalization after ER admission.</description>
        <time_frame>Length of stay in the ER - up to one day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Small Volume Jet Nebulizer</title>
            <description>Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The bronchodilators will be administered via small volume jet nebulizer</description>
          </group>
          <group group_id="O2">
            <title>Aeroneb Nebulizer</title>
            <description>Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.&#xD;
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Requiring Hospitalization</title>
          <description>Total amount of patients requiring hospitalization after ER admission.</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="15"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Total Dose of Albuterol Used in Each Group During ED Stay</title>
        <description>Albuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease.</description>
        <time_frame>Length of stay in the ER - up to one day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Small Volume Jet Nebulizer</title>
            <description>Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The bronchodilators will be administered via small volume jet nebulizer</description>
          </group>
          <group group_id="O2">
            <title>Aeroneb Nebulizer</title>
            <description>Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.&#xD;
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).</description>
          </group>
        </group_list>
        <measure>
          <title>The Total Dose of Albuterol Used in Each Group During ED Stay</title>
          <description>Albuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease.</description>
          <units>dosage (mg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" spread="2.97"/>
                    <measurement group_id="O2" value="7.2" spread="4.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>The Total Dose of Ipratropium Used in Each Group During ED Stay</title>
        <description>Ipratropium is used to prevent wheezing, shortness of breath, coughing and chest tightness in people with chronic obstructive pulmonary disease, chronic bronchitis, and emphysema. It is a bronchodilator which relaxes and opens the air passages to the lungs to make breathing easier.</description>
        <time_frame>Length of stay in the ER - up to one day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Small Volume Jet Nebulizer</title>
            <description>Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The bronchodilators will be administered via small volume jet nebulizer</description>
          </group>
          <group group_id="O2">
            <title>Aeroneb Nebulizer</title>
            <description>Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.&#xD;
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).</description>
          </group>
        </group_list>
        <measure>
          <title>The Total Dose of Ipratropium Used in Each Group During ED Stay</title>
          <description>Ipratropium is used to prevent wheezing, shortness of breath, coughing and chest tightness in people with chronic obstructive pulmonary disease, chronic bronchitis, and emphysema. It is a bronchodilator which relaxes and opens the air passages to the lungs to make breathing easier.</description>
          <units>dosage (mg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="0.44"/>
                    <measurement group_id="O2" value="1.1" spread="0.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events data was collected for 2 years, the duration of the study.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Small Volume Jet Nebulizer</title>
          <description>Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The bronchodilators will be administered via small volume jet nebulizer</description>
        </group>
        <group group_id="E2">
          <title>Aeroneb Nebulizer</title>
          <description>Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.&#xD;
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.&#xD;
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).</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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </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>Nicholas S. Hill</name_or_title>
      <organization>Tufts Medical Center</organization>
      <phone>617-636-0688</phone>
      <email>nhill@tuftsmedicalcenter.org</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/NCT03029156
org study id: 11643
nct id: NCT03029156
lead sponsor: 
has dmc: No
Background: The bronchodilator therapy is an essential component of the management of asthma
      exacerbation. The delivery of bronchodilators to the lungs in asthma exacerbations is usually
      achieved through nebulization (creating small particles to be inhaled). The commonly used
      nebulizer device is a small volume jet nebulizer which has not been consistently reliable in
      delivering bronchodilator therapy. The Aeroneb nebulizer device is a FDA approved device
      which produces consistently respirable sized particles which could potentially result in
      better bronchodilator effect than the standard jet nebulizer.

      Aim: To study whether the Aeroneb nebulizer is more effective than a small volume jet
      nebulizer in delivering bronchodilators during a severe asthma exacerbation.

      Experimental design: Patients will be randomized (like a flip of a coin) to receive
      bronchodilator therapy as per the emergency room protocol either via small volume jet
      nebulizer or Aeroneb nebulizer.

      Subjects: Adult patients between age of 18 and 55 years who present to the emergency room
      with severe asthma exacerbation with peak expiratory flow rate <50% of predicted.

      Study procedure: When enrolled in the study and after randomization, we will then collect
      data that is standard for the hospital like heart rate, blood pressure and breathing indices
      and also some non-routine things like some scoring scales for shortness of breath and serial
      measurements of peak expiratory flow rate. We anticipate that the Aeroneb device will be more
      effective in delivering bronchodilator medication and thus more effective in managing asthma
      exacerbations.
-  Patients presenting with acute severe asthma exacerbations to the emergency room will be
           screened by the PI, co-investigator or research coordinator to determine their
           eligibility based on the inclusion and exclusion criteria.

        -  Clinically indicated treatment must not be delayed for a research-related reason so
           patients will still be eligible for enrollment after receiving initial bronchodilator
           therapy as long as their PEFR remains <50% of predicted and enrollment occurs within 90
           minutes of the ER arrival time.

        -  The initial part of the consent process will cover the essential elements of the
           informed consent in a concise manner to ensure a timely process

        -  Eligible patients will be randomized using the concealed envelope method to either the
           intervention arm or the control arm. The randomization should take place within 90
           minutes of ER arrival, however, every effort will be made to enroll the patient as soon
           as possible; patients will be enrolled as long as their PEFR is less than 50% of
           predicted regardless of the number of bronchodilator treatments they received prior to
           randomization.

        -  The assignment will be blinded to the recording investigator and the treating physician
           but not to the patient or the nurse or respiratory therapist who is administering the
           nebulization. In order to avoid any delay in administering the treatments, the sets of
           Aeroneb nebulizer and small volume jet nebulizer will be stored in identical boxes and
           will be readily available in the ER.

      In order to blind the treating physician and the recording investigator, a sign "treatment in
      progress" will be displayed at the outdoor of the ER room when the patient is getting the
      bronchodilator treatment. The nebulizer devices will be placed in the box between the
      bronchodilator treatment sessions. The physician and the recording investigator will be asked
      if possible to see the patients only when the sign is taken off the outdoor.

        -  Once assigned, all the bronchodilator treatments in the ER will be administered using
           the nebulizer device assigned to that patient.

        -  The Peak flow and FEV1 will be measured using Spirometer (micro I). Both values will be
           obtained through the same exhalation maneuver.

        -  Patient will be treated and managed according to the asthma ER adult protocol or as
           directed by the ER physician who is in charge of patient's care

        -  After the study procedures have been performed and the subject is determined to be in
           stable condition and have the capacity to make medical decisions, the investigator will
           approach the subject again and review all the elements of the ICF again with the
           subject. The collected data will be used only if the subject signs both parts of the
           informed consent.

        -  Within two weeks of the subject participation, the research team will conduct a phone
           interview with the subject to obtain their feedback on the study procedures and mainly
           on the informed consent process. The phone interview questionnaire is included in the
           supplement
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Percentage Change in Mean of Peak Expiratory Flow Rate (PEFR) Percentage of Predicted Baseline at 30 Minutes After the Initial Bronchodilator Treatment
time frame: 30 minutes
description: Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration.
measure: Percentage Change in the PEFR Percentage of Predicted Baseline to Disposition
time frame: Initial bronchodilator treatment to disposition, an average of 4 hours
description: Change in the PEFR percent predicted from the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group.
measure: Percentage Change in the Forced Expiratory Volume (FEV1) Percentage of Predicted Baseline to Disposition
time frame: initial bronchodilator treatment to disposition, an average of 4 hours
description: Forced expiratory volume refers to the volume of air that an individual can exhale during a forced breath in 1 second.
measure: Change in the Borg-Dyspnea Score From Baseline to Disposition
time frame: initial bronchodilator treatment to disposition, an average of 4 hours
description: The Borg-Dyspnea score measures an individual's effort, exertion, breathlessness and fatigue during physical work. This scale ranges from 6-20 with 6 representing no exertion at all and 20 representing maximal exertion.
measure: Change in Heart Rate Baseline to Disposition
time frame: The initial bronchodilator treatment to to disposition, an average of 4 hours
description: Change in the heart rate at baseline after the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group.
measure: Length of Stay in the ER
time frame: Length of stay in the ER - up to one day
description: Total length from admission to discharge.
measure: Percentage of Patients Requiring Hospitalization
time frame: Length of stay in the ER - up to one day
description: Total amount of patients requiring hospitalization after ER admission.
measure: The Total Dose of Albuterol Used in Each Group During ED Stay
time frame: Length of stay in the ER - up to one day
description: Albuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease.
measure: The Total Dose of Ipratropium Used in Each Group During ED Stay
time frame: Length of stay in the ER - up to one day
description: Ipratropium is used to prevent wheezing, shortness of breath, coughing and chest tightness in people with chronic obstructive pulmonary disease, chronic bronchitis, and emphysema. It is a bronchodilator which relaxes and opens the air passages to the lungs to make breathing easier.
arm group label: Small volume jet nebulizer
arm group type: Active Comparator
description: Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.
arm group label: Aeroneb nebulizer
arm group type: Experimental
description: Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.
intervention type: Device
intervention name: Aeroneb nebulizer
description: The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).
arm group label: Aeroneb nebulizer
other name: Vibrating mesh nebulizer
intervention type: Device
intervention name: Small volume jet nebulizer
description: The bronchodilators will be administered via small volume jet nebulizer
arm group label: Small volume jet nebulizer
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Nicholas S Hill, MD
role: Principal Investigator
affiliation: Tufts Medical Center
facility: 
country: United States
citation: McFadden ER Jr. Acute severe asthma. Am J Respir Crit Care Med. 2003 Oct 1;168(7):740-59. doi: 10.1164/rccm.200208-902SO.
PMID: 14522812
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: Rodrigo G, Rodrigo C. A new index for early prediction of hospitalization in patients with acute asthma. Am J Emerg Med. 1997 Jan;15(1):8-13. doi: 10.1016/s0735-6757(97)90039-5.
PMID: 9002561
citation: Rodrigo G, Rodrigo C. Early prediction of poor response in acute asthma patients in the emergency department. Chest. 1998 Oct;114(4):1016-21. doi: 10.1378/chest.114.4.1016.
PMID: 9792570
citation: Piovesan DM, Menegotto DM, Kang S, Franciscatto E, Millan T, Hoffmann C, Pasin LR, Fischer J, Barreto SS, Dalcin Pde T. Early prognosis of acute asthma in the emergency room. J Bras Pneumol. 2006 Jan-Feb;32(1):1-9. doi: 10.1590/s1806-37132006000100004. English, Portuguese.
PMID: 17273562
citation: Ari A, Atalay OT, Harwood R, Sheard MM, Aljamhan EA, Fink JB. Influence of nebulizer type, position, and bias flow on aerosol drug delivery in simulated pediatric and adult lung models during mechanical ventilation. Respir Care. 2010 Jul;55(7):845-51.
PMID: 20587095
citation: Galindo-Filho VC, Ramos ME, Rattes CS, Barbosa AK, Brandao DC, Brandao SC, Fink JB, de Andrade AD. Radioaerosol Pulmonary Deposition Using Mesh and Jet Nebulizers During Noninvasive Ventilation in Healthy Subjects. Respir Care. 2015 Sep;60(9):1238-46. doi: 10.4187/respcare.03667. Epub 2015 Jun 23.
PMID: 26106207
citation: Alvine GF, Rodgers P, Fitzsimmons KM, Ahrens RC. Disposable jet nebulizers. How reliable are they? Chest. 1992 Feb;101(2):316-9. doi: 10.1378/chest.101.2.316.
PMID: 1735247
citation: Borg G. Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med. 1970;2(2):92-8. No abstract available.
PMID: 5523831
citation: Patrick W, Webster K, Ludwig L, Roberts D, Wiebe P, Younes M. Noninvasive positive-pressure ventilation in acute respiratory distress without prior chronic respiratory failure. Am J Respir Crit Care Med. 1996 Mar;153(3):1005-11. doi: 10.1164/ajrccm.153.3.8630538.
PMID: 8630538
responsible party type: Sponsor
mesh term: Asthma
mesh term: Status Asthmaticus
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 