<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/NCT02245074</url>
  </required_header>
  <id_info>
    <org_study_id>2009/056/HP</org_study_id>
    <secondary_id>2009- A00774-53</secondary_id>
    <nct_id>NCT02245074</nct_id>
  </id_info>
  <brief_title>Non Invasive Evaluation of Bronchial Inflammation in Infants : a Study of the Sputum Cellularity After Hypertonic Saline Induction</brief_title>
  <acronym>CYTOASTHME</acronym>
  <official_title>Non Invasive Evaluation of Bronchial Inflammation in Infants : a Study of the Sputum Cellularity After Hypertonic Saline Induction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Background: Infantile asthma is composed of various phenotypes, however the definition&#xD;
           is still based on the clinics. Namely, the infants could be classified as transitory,&#xD;
           peristent or late and persistent asthma. Some risk factors for the persistent asthma&#xD;
           phenotype are recognized as atopy. However all peristent asthma are not related to&#xD;
           atopy. Regarding the pathophysiology, little is known on airways inflammation in these&#xD;
           infants, and the current data are mostly based on the BAL analyses, or on biopsies.&#xD;
           Consequently, BLA and biopsies should be justified by the need of an indicated&#xD;
           fiberbronchoscopy, and therefore limited to severe infantile asthma. Airway secretion&#xD;
           could be also collected after hypertonic saline induction and chest physiotherapy. This&#xD;
           method has been validated in the children, but has not in the younger.&#xD;
&#xD;
        -  Aim : Analyses of cell profiles regarding the severity of infantile asthma.&#xD;
&#xD;
        -  Methods : This descriptive study compared 3 groups of infants, the first with acute&#xD;
           exacerbation, the second with uncontrolled asthma and the third with controlled asthma.&#xD;
           Accounting 25% of failure, the number of 40 infants per groups has been calculated. The&#xD;
           sputum induction will be performed by repeated nebulizations of 3% saline hypertonic&#xD;
           solution. Cellularity and cell profiles were analysed as previously recommended. Safety&#xD;
           will be evaluated.&#xD;
&#xD;
        -  Inclusion criteria : Any infants suffering of infantile asthma (at least 3 episodes of&#xD;
           wheezing during the 2 first years of life), aged between 6-12months.Asthma control was&#xD;
           evaluated on the last 4 weeks, allowing to classify the infants . Control asthma was&#xD;
           aimed when neither exacerbation nor persistent symptoms were observed. Uncontrolled&#xD;
           asthma was defined whether the infant presented any symptoms during the last 4 weeks.&#xD;
           Exacerbation was defined as any acute symptoms, as cough, dyspnoea or wheezing.&#xD;
&#xD;
        -  Feasibility : A preliminary study has been presented in the Vienna ERS congress.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    lack of recruitment&#xD;
  </why_stopped>
  <start_date>June 2010</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cell profiles Analysis regarding the severity of asthma as defined above.</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Infantile Asthma</condition>
  <arm_group>
    <arm_group_label>Acute exacerbation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cell profiles Analysis after sputum induction in infants with Acute exacerbation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Uncontrolled asthma</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cell profiles Analysis after sputum induction in infants with Uncontrolled asthma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controlled asthma</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cell profiles Analysis after sputum induction in infants controlled asthma</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sputum induction</intervention_name>
    <description>The sputum induction will be performed by repeated nebulizations of 3% saline hypertonic solution. Cellularity and cell profiles were analysed as previously recommended.</description>
    <arm_group_label>Acute exacerbation</arm_group_label>
    <arm_group_label>Uncontrolled asthma</arm_group_label>
    <arm_group_label>controlled asthma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 6 and 36 mo.&#xD;
&#xD;
          -  Ambulatory or hospitalized.&#xD;
&#xD;
          -  With %SaO2 ³ 95%&#xD;
&#xD;
          -  Parents information and non-opposition from the parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any underlying chronic disease&#xD;
&#xD;
          -  Been given oral corticosteroid during the last four weeks&#xD;
&#xD;
          -  Known adverse events with nebulized saline solution&#xD;
&#xD;
          -  With cold during the 4 last weeks for the controled group.&#xD;
&#xD;
          -  With %SaO2 &lt; 95%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christophe MARGUET, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Rouen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pediatric Department</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 15, 2010</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 17, 2014</last_update_submitted>
  <last_update_submitted_qc>September 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infantile asthma</keyword>
  <keyword>Induced sputum</keyword>
  <keyword>Phenotypes</keyword>
  <keyword>Eosinophils</keyword>
  <keyword>Neutrophils</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <!-- 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/NCT02245074
org study id: 2009/056/HP
secondary id: 2009- A00774-53
nct id: NCT02245074
lead sponsor: 
has dmc: No
-  Background: Infantile asthma is composed of various phenotypes, however the definition
           is still based on the clinics. Namely, the infants could be classified as transitory,
           peristent or late and persistent asthma. Some risk factors for the persistent asthma
           phenotype are recognized as atopy. However all peristent asthma are not related to
           atopy. Regarding the pathophysiology, little is known on airways inflammation in these
           infants, and the current data are mostly based on the BAL analyses, or on biopsies.
           Consequently, BLA and biopsies should be justified by the need of an indicated
           fiberbronchoscopy, and therefore limited to severe infantile asthma. Airway secretion
           could be also collected after hypertonic saline induction and chest physiotherapy. This
           method has been validated in the children, but has not in the younger.

        -  Aim : Analyses of cell profiles regarding the severity of infantile asthma.

        -  Methods : This descriptive study compared 3 groups of infants, the first with acute
           exacerbation, the second with uncontrolled asthma and the third with controlled asthma.
           Accounting 25% of failure, the number of 40 infants per groups has been calculated. The
           sputum induction will be performed by repeated nebulizations of 3% saline hypertonic
           solution. Cellularity and cell profiles were analysed as previously recommended. Safety
           will be evaluated.

        -  Inclusion criteria : Any infants suffering of infantile asthma (at least 3 episodes of
           wheezing during the 2 first years of life), aged between 6-12months.Asthma control was
           evaluated on the last 4 weeks, allowing to classify the infants . Control asthma was
           aimed when neither exacerbation nor persistent symptoms were observed. Uncontrolled
           asthma was defined whether the infant presented any symptoms during the last 4 weeks.
           Exacerbation was defined as any acute symptoms, as cough, dyspnoea or wheezing.

        -  Feasibility : A preliminary study has been presented in the Vienna ERS congress.
allocation: Non-Randomized
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Cell profiles Analysis regarding the severity of asthma as defined above.
time frame: Day 1
arm group label: Acute exacerbation
arm group type: Other
description: Cell profiles Analysis after sputum induction in infants with Acute exacerbation
arm group label: Uncontrolled asthma
arm group type: Other
description: Cell profiles Analysis after sputum induction in infants with Uncontrolled asthma
arm group label: controlled asthma
arm group type: Other
description: Cell profiles Analysis after sputum induction in infants controlled asthma
intervention type: Other
intervention name: Sputum induction
description: The sputum induction will be performed by repeated nebulizations of 3% saline hypertonic solution. Cellularity and cell profiles were analysed as previously recommended.
arm group label: Acute exacerbation
arm group label: Uncontrolled asthma
arm group label: controlled asthma
criteria: 
gender: All
minimum age: 6 Months
maximum age: 3 Years
healthy volunteers: No
last name: Christophe MARGUET, Professor
role: Principal Investigator
affiliation: University Hospital, Rouen
facility: 
country: France
responsible party type: Sponsor
mesh term: Inflammation