<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/NCT03042065</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01276-45</org_study_id>
    <nct_id>NCT03042065</nct_id>
  </id_info>
  <brief_title>Salbutamol in the Pediatric Emergencies: Nebulization Estimated Via AerogeN or Jet</brief_title>
  <acronym>SIBILANT</acronym>
  <official_title>Salbutamol in the Pediatric Emergencies: Nebulization Estimated Via AerogeN or Jet</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre d'Investigation Clinique et Technologique 805</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre d'Investigation Clinique et Technologique 805</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Controlled trial of nebulized salbutamol using jet nebulizer or vibrating mesh technology in&#xD;
      children presenting with acute moderate to severe asthma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Asthma is a chronic (long-term) lung disease that inflames and narrows the airways. Asthma&#xD;
      causes recurring periods of wheezing (a whistling sound when you breathe), chest tightness,&#xD;
      shortness of breath, and coughing. The coughing often occurs at night or early in the&#xD;
      morning. Sometimes asthma symptoms are mild and go away on their own or after minimal&#xD;
      treatment with asthma medicine. Other times, symptoms continue to get worse. When symptoms&#xD;
      get more intense and/or more symptoms occur, it is called an asthma attack. Asthma attacks&#xD;
      also are called flare-ups or exacerbation.&#xD;
&#xD;
      International Study of Asthma and Allergies in Childhood (ISAAC) found that about 14% of the&#xD;
      world's children were likely to have had asthmatic symptoms in the last year and, crucially,&#xD;
      the prevalence of childhood asthma varies widely between countries, and between centers&#xD;
      within countries studied. These conclusions resulted from ISAAC's groundbreaking survey of a&#xD;
      representative sample of 798,685 children aged 13-14 years in 233 centers in 97 countries.&#xD;
      (ISAAC also studied a younger age group of children (6-7 years) and the findings were&#xD;
      generally similar to the older children). These adolescents were asked whether they had&#xD;
      experienced wheeze in the preceding 12 months. Prevalence of recent wheeze varied widely. The&#xD;
      highest prevalence (&gt;20%) was generally observed in Latin America and in English-speaking&#xD;
      countries of Australasia, Europe and North America as well as South Africa. The lowest&#xD;
      prevalence (&lt;5%) was observed in the Indian subcontinent, Asia-Pacific, Eastern&#xD;
      Mediterranean, and Northern and Eastern Europe. In Africa, 10-20% prevalence was mostly&#xD;
      observed .&#xD;
&#xD;
      The majority of children with asthma have stable disease, and only a minority experience&#xD;
      exacerbations needing hospitalization or emergency room visits. In older children, recent&#xD;
      advances in treatment seem to have reduced chronic morbidity as well as the number of acute&#xD;
      exacerbations. In infants and younger children, this goal may be more difficult to achieve,&#xD;
      given the heterogeneity of obstructive lung disease in this age group. Viral wheeze is a very&#xD;
      common clinical scenario in young children, and identification and proper treatment of&#xD;
      subjects with potential for development of asthma and future exacerbations is still an&#xD;
      unresolved challenge. Even if severe asthma exacerbations are relatively common, mortality&#xD;
      from asthma in children is rare and declining. In the United Kingdom the mortality rate for&#xD;
      children 0-14 years is less than one per 100.000 children per year. In contrast, there has&#xD;
      been a vast increase in the economic costs associated with asthma. However, the main economic&#xD;
      burden of childhood asthma is linked to indirect costs, long-term follow up and medication,&#xD;
      and not to hospitalization .&#xD;
&#xD;
      Acute severe asthma represents one of the most common medical emergency situations and the&#xD;
      most serious clinical presentation of asthma. Asthma is typically characterized by the&#xD;
      presence of severe respiratory distress due to an asthma episode that requires the use of&#xD;
      bronchodilators, oxygen and corticosteroids. Asthma attack can be severe and even life&#xD;
      threatening. Features of acute severe attack include; Peak expiratory flow (PEF) 33-50% of&#xD;
      best (use % predicted if recent best unknown), tachycardia and tachypnea. Life threatening&#xD;
      attack includes pulse oxymetry &lt;92%, Silent chest, cyanosis, or feeble respiratory effort,&#xD;
      Arrhythmia or hypotension Exhaustion, altered consciousness. A severe asthma exacerbation can&#xD;
      usually be presented clinically with dyspnea at rest; interferes with conversation and peak&#xD;
      expiratory flow rate (PEFR) &lt; 40%, usually requires hospitalization .&#xD;
&#xD;
      Acute severe asthma is one of the most common medical emergency situations in childhood, and&#xD;
      physicians caring for acutely ill children are regularly faced with this condition. The&#xD;
      cornerstones of the management of acute asthma in children are rapid administration of&#xD;
      oxygen, inhalations with bronchodilators and systemic corticosteroids. Inhaled&#xD;
      bronchodilators may include selective b2-agonists, adrenaline and anticholinergics.&#xD;
      Additional treatment in selected cases may involve intravenous administration of&#xD;
      theophylline, b2-agonists and magnesium sulphate. Both non-invasive and invasive ventilation&#xD;
      may be options when medical treatment fails to prevent respiratory failure. It is important&#xD;
      that relevant treatment algorithms exist, applicable to all levels of the treatment chain and&#xD;
      reflecting local considerations and circumstances .&#xD;
&#xD;
      Despite recent progress in the treatment of chronic asthma in childhood, acute exacerbations&#xD;
      will continue to occur. Physicians working within the field of pediatric emergency medicine&#xD;
      will therefore continue to be exposed to this clinical scenario. The cornerstones of acute&#xD;
      asthma management in childhood remain rapid onset of oxygen treatment, inhalation of&#xD;
      bronchodilators and systemic corticosteroids. Short-acting bronchodilators provide immediate&#xD;
      relief of asthma symptoms and effects last four to six hours. The most commonly used&#xD;
      short-acting bronchodilator for asthma is albuterol. These medications work quickly, and help&#xD;
      to control symptoms of severe asthma attack. The doses as well as the way of delivery are&#xD;
      important to reach the best bronchodilator effect. The amount of product that effectively&#xD;
      reaches the bronchi is relatively small as 0.1% to 11%, respectively using a lung simulator .&#xD;
      Despite this high variation of the amount of product delivery to the patient and the narrow&#xD;
      limits of dose between benefice and side effects, the aerosolized route remained the&#xD;
      preferred one even in severe cases .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2017</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The main analysis criteria is the Peak expiratory flow (PEF) value performed before the first aerosol of salbutamol aerosols using Jet or Aerogen spray.</measure>
    <time_frame>2 minutes</time_frame>
    <description>before the first nebulization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The main analysis criteria is the Peak expiratory flow (PEF) value performed after the first aerosol of salbutamol aerosols using Jet or Aerogen spray.</measure>
    <time_frame>2 minutes</time_frame>
    <description>after the first nebulization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The main analysis criteria is the Peak expiratory flow (PEF) value performed after the second aerosol of salbutamol aerosols using Jet or Aerogen spray.</measure>
    <time_frame>2 minutes</time_frame>
    <description>after the second nebulization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The main analysis criteria is the Peak expiratory flow (PEF) value performed after the third aerosol of salbutamol aerosols using Jet or Aerogen spray.</measure>
    <time_frame>2 minutes</time_frame>
    <description>after the third nebulization</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>vibrating Mesh nebulizer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive in the same aerosol solution 5 mg of Salbutamol (Ventolin, Glaxo, 5 mg / ml solution for nebulization) mixed with 0.5 mg Ipratropium Bromide (0.25 mg / ml) by nebulization every 20 min For 3 doses during the first hour of treatment, using vibrating Mesh nebulizer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>jet nebulizer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receive, in the same aerosol solution, 5 mg of Salbutamol (Ventolin, Glaxo, 5 mg / ml solution for nebulization) mixed with 0.5 mg Ipratropium Bromide (0.25 mg / ml) by nebulization every 20 min For 3 doses during the first hour of treatment, using a jet nebulizer</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>vibrating Mesh nebulizer</intervention_name>
    <description>Receive in the same aerosol solution 5 mg of Salbutamol (Ventolin, Glaxo, 5 mg / ml solution for nebulization) mixed with 0.5 mg Ipratropium Bromide (0.25 mg / ml) by nebulization every 20 min For 3 doses during the first hour of treatment, using vibrating Mesh nebulizer</description>
    <arm_group_label>vibrating Mesh nebulizer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>jet nebulizer</intervention_name>
    <description>Receive in the same aerosol solution 5 mg of Salbutamol (Ventolin, Glaxo, 5 mg / ml solution for nebulization) mixed with 0.5 mg Ipratropium Bromide (0.25 mg / ml) by nebulization every 20 min For 3 doses during the first hour of treatment, using jet nebulizer</description>
    <arm_group_label>jet nebulizer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 8-16 years.&#xD;
&#xD;
          -  Patient with severe asthma (maximum expiratory flow &lt;50%).&#xD;
&#xD;
          -  Patient admitted to pediatric emergency.&#xD;
&#xD;
          -  Patient who has agreed to participate, as well as the parents or legal guardian.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Chronic respiratory failure, infectious disease, heart disease.&#xD;
&#xD;
          -  Refusal to participate in the study.&#xD;
&#xD;
          -  No affiliation to a social security scheme (beneficiary or beneficiary).&#xD;
&#xD;
          -  Immediate intubation criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean BERGOUNIOUX, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>JEAN BERGOUNIOUX, MD</last_name>
    <phone>0033147101131</phone>
    <email>jean.bergounioux@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>sandra POTTIER, CRA</last_name>
    <phone>0033147104469</phone>
    <email>sandra.pottier@aphp.fr</email>
  </overall_contact_backup>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pediatrics</keyword>
  <keyword>asthma</keyword>
  <keyword>nebulization</keyword>
  <keyword>vibrating mesh</keyword>
  <keyword>salbutamol</keyword>
  <keyword>Efficiency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03042065
org study id: 2016-A01276-45
nct id: NCT03042065
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Controlled trial of nebulized salbutamol using jet nebulizer or vibrating mesh technology in
      children presenting with acute moderate to severe asthma.
Asthma is a chronic (long-term) lung disease that inflames and narrows the airways. Asthma
      causes recurring periods of wheezing (a whistling sound when you breathe), chest tightness,
      shortness of breath, and coughing. The coughing often occurs at night or early in the
      morning. Sometimes asthma symptoms are mild and go away on their own or after minimal
      treatment with asthma medicine. Other times, symptoms continue to get worse. When symptoms
      get more intense and/or more symptoms occur, it is called an asthma attack. Asthma attacks
      also are called flare-ups or exacerbation.

      International Study of Asthma and Allergies in Childhood (ISAAC) found that about 14% of the
      world's children were likely to have had asthmatic symptoms in the last year and, crucially,
      the prevalence of childhood asthma varies widely between countries, and between centers
      within countries studied. These conclusions resulted from ISAAC's groundbreaking survey of a
      representative sample of 798,685 children aged 13-14 years in 233 centers in 97 countries.
      (ISAAC also studied a younger age group of children (6-7 years) and the findings were
      generally similar to the older children). These adolescents were asked whether they had
      experienced wheeze in the preceding 12 months. Prevalence of recent wheeze varied widely. The
      highest prevalence (>20%) was generally observed in Latin America and in English-speaking
      countries of Australasia, Europe and North America as well as South Africa. The lowest
      prevalence (<5%) was observed in the Indian subcontinent, Asia-Pacific, Eastern
      Mediterranean, and Northern and Eastern Europe. In Africa, 10-20% prevalence was mostly
      observed .

      The majority of children with asthma have stable disease, and only a minority experience
      exacerbations needing hospitalization or emergency room visits. In older children, recent
      advances in treatment seem to have reduced chronic morbidity as well as the number of acute
      exacerbations. In infants and younger children, this goal may be more difficult to achieve,
      given the heterogeneity of obstructive lung disease in this age group. Viral wheeze is a very
      common clinical scenario in young children, and identification and proper treatment of
      subjects with potential for development of asthma and future exacerbations is still an
      unresolved challenge. Even if severe asthma exacerbations are relatively common, mortality
      from asthma in children is rare and declining. In the United Kingdom the mortality rate for
      children 0-14 years is less than one per 100.000 children per year. In contrast, there has
      been a vast increase in the economic costs associated with asthma. However, the main economic
      burden of childhood asthma is linked to indirect costs, long-term follow up and medication,
      and not to hospitalization .

      Acute severe asthma represents one of the most common medical emergency situations and the
      most serious clinical presentation of asthma. Asthma is typically characterized by the
      presence of severe respiratory distress due to an asthma episode that requires the use of
      bronchodilators, oxygen and corticosteroids. Asthma attack can be severe and even life
      threatening. Features of acute severe attack include; Peak expiratory flow (PEF) 33-50% of
      best (use % predicted if recent best unknown), tachycardia and tachypnea. Life threatening
      attack includes pulse oxymetry <92%, Silent chest, cyanosis, or feeble respiratory effort,
      Arrhythmia or hypotension Exhaustion, altered consciousness. A severe asthma exacerbation can
      usually be presented clinically with dyspnea at rest; interferes with conversation and peak
      expiratory flow rate (PEFR) < 40%, usually requires hospitalization .

      Acute severe asthma is one of the most common medical emergency situations in childhood, and
      physicians caring for acutely ill children are regularly faced with this condition. The
      cornerstones of the management of acute asthma in children are rapid administration of
      oxygen, inhalations with bronchodilators and systemic corticosteroids. Inhaled
      bronchodilators may include selective b2-agonists, adrenaline and anticholinergics.
      Additional treatment in selected cases may involve intravenous administration of
      theophylline, b2-agonists and magnesium sulphate. Both non-invasive and invasive ventilation
      may be options when medical treatment fails to prevent respiratory failure. It is important
      that relevant treatment algorithms exist, applicable to all levels of the treatment chain and
      reflecting local considerations and circumstances .

      Despite recent progress in the treatment of chronic asthma in childhood, acute exacerbations
      will continue to occur. Physicians working within the field of pediatric emergency medicine
      will therefore continue to be exposed to this clinical scenario. The cornerstones of acute
      asthma management in childhood remain rapid onset of oxygen treatment, inhalation of
      bronchodilators and systemic corticosteroids. Short-acting bronchodilators provide immediate
      relief of asthma symptoms and effects last four to six hours. The most commonly used
      short-acting bronchodilator for asthma is albuterol. These medications work quickly, and help
      to control symptoms of severe asthma attack. The doses as well as the way of delivery are
      important to reach the best bronchodilator effect. The amount of product that effectively
      reaches the bronchi is relatively small as 0.1% to 11%, respectively using a lung simulator .
      Despite this high variation of the amount of product delivery to the patient and the narrow
      limits of dose between benefice and side effects, the aerosolized route remained the
      preferred one even in severe cases .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: The main analysis criteria is the Peak expiratory flow (PEF) value performed before the first aerosol of salbutamol aerosols using Jet or Aerogen spray.
time frame: 2 minutes
description: before the first nebulization
measure: The main analysis criteria is the Peak expiratory flow (PEF) value performed after the first aerosol of salbutamol aerosols using Jet or Aerogen spray.
time frame: 2 minutes
description: after the first nebulization
measure: The main analysis criteria is the Peak expiratory flow (PEF) value performed after the second aerosol of salbutamol aerosols using Jet or Aerogen spray.
time frame: 2 minutes
description: after the second nebulization
measure: The main analysis criteria is the Peak expiratory flow (PEF) value performed after the third aerosol of salbutamol aerosols using Jet or Aerogen spray.
time frame: 2 minutes
description: after the third nebulization
arm group label: vibrating Mesh nebulizer
arm group type: Experimental
description: Receive in the same aerosol solution 5 mg of Salbutamol (Ventolin, Glaxo, 5 mg / ml solution for nebulization) mixed with 0.5 mg Ipratropium Bromide (0.25 mg / ml) by nebulization every 20 min For 3 doses during the first hour of treatment, using vibrating Mesh nebulizer
arm group label: jet nebulizer
arm group type: Active Comparator
description: Receive, in the same aerosol solution, 5 mg of Salbutamol (Ventolin, Glaxo, 5 mg / ml solution for nebulization) mixed with 0.5 mg Ipratropium Bromide (0.25 mg / ml) by nebulization every 20 min For 3 doses during the first hour of treatment, using a jet nebulizer
intervention type: Device
intervention name: vibrating Mesh nebulizer
description: Receive in the same aerosol solution 5 mg of Salbutamol (Ventolin, Glaxo, 5 mg / ml solution for nebulization) mixed with 0.5 mg Ipratropium Bromide (0.25 mg / ml) by nebulization every 20 min For 3 doses during the first hour of treatment, using vibrating Mesh nebulizer
arm group label: vibrating Mesh nebulizer
intervention type: Device
intervention name: jet nebulizer
description: Receive in the same aerosol solution 5 mg of Salbutamol (Ventolin, Glaxo, 5 mg / ml solution for nebulization) mixed with 0.5 mg Ipratropium Bromide (0.25 mg / ml) by nebulization every 20 min For 3 doses during the first hour of treatment, using jet nebulizer
arm group label: jet nebulizer
criteria: 
gender: All
minimum age: 8 Years
maximum age: 16 Years
healthy volunteers: No
last name: Jean BERGOUNIOUX, MD
role: Principal Investigator
affiliation: APHP
last name: JEAN BERGOUNIOUX, MD
phone: 0033147101131
email: jean.bergounioux@aphp.fr
last name: sandra POTTIER, CRA
phone: 0033147104469
email: sandra.pottier@aphp.fr
responsible party type: Sponsor
mesh term: Emergencies
sharing ipd: No