xml: <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/NCT06024902</url>
    </required_header>
    <id_info>
      <org_study_id>2023-002</org_study_id>
      <nct_id>NCT06024902</nct_id>
    </id_info>
    <brief_title>Clinical Characteristics of Severe Childhood Asthma</brief_title>
    <official_title>Clinical Characteristics of Severe Childhood Asthma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Hospital of Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Children's Hospital of Fudan University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Asthma remains a serious health problem with increasing prevalence and incidence. There is&#xD;
        limited information about severe asthma among Chinese pediatric patients. In this context, we&#xD;
        decided to explore the clinical characteristics and risk factors of severe asthma in&#xD;
        children. This is a descriptive, observational, retrospective cohort study in children with&#xD;
        asthma.&#xD;
  &#xD;
        The purpose of this retrospective study is: to determine the clinical characteristics of&#xD;
        severe asthma of children; to identify the factors associated with severe childhood asthma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Asthma remains a serious health problem with increasing prevalence and incidence. There is&#xD;
        limited information about severe asthma among Chinese pediatric patients. In this context, we&#xD;
        decided to explore the clinical characteristics and risk factors of severe asthma in&#xD;
        children. This is a descriptive, observational, retrospective cohort study in children with&#xD;
        asthma.&#xD;
  &#xD;
        The purpose of this retrospective study is: to determine the clinical characteristics of&#xD;
        severe asthma of children; to identify the factors associated with severe childhood asthma.&#xD;
  &#xD;
        Participants were consecutively recruited from asthma clinics between January 2021 and&#xD;
        December 2021 at Children's Hospital of Fudan University. Patients fulfilling the following&#xD;
        criteria were eligible for inclusion: (1) aged 6-17 years old; (2) diagnosed with asthma&#xD;
        according to the Global Initiative for Asthma (GINA) 2020 guideline; (3) children and their&#xD;
        caregivers are informed and voluntarily join the database and had follow up for at least 1&#xD;
        year. Patients who had cystic fibrosis, mechanical airway obstruction, or any other pulmonary&#xD;
        disease or whose parents or legal guardians were not able to fill in the questionnaires were&#xD;
        not enrolled.&#xD;
  &#xD;
        At baseline, the asthma specialist questioned each of the patient in the presence of their&#xD;
        caregivers to ensure that they supplied accurate disease information and were included&#xD;
        according to the criteria. The patients and their caregivers are asked to complete the online&#xD;
        questionnaires including the demographic; baseline asthma control, triggers, exacerbation,&#xD;
        medication and adherence; environmental exposure, and diagnosis and control of comorbidities,&#xD;
        etc. If a patient had poorly controlled comorbidities, multidisciplinary consultation would&#xD;
        be recommended. Clinical assessments were arranged at baseline, 3, 6, 9, and 12 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Actual">December 31, 2022</completion_date>
    <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Severity of asthma</measure>
      <time_frame>12 months</time_frame>
      <description>The severity of asthma was comprehensively estimated by a pediatric pulmonologist following the criteria of the Global Initiative for Asthma (GINA) 2021 when patients completed 12-months management.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">674</enrollment>
    <condition>Severe Asthma</condition>
    <arm_group>
      <arm_group_label>childhood asthma</arm_group_label>
      <description>Subjects with confirmed diagnosis of asthma without other lung disease followed for collection of demographic and clinical data.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          The tertiary specialized children's hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  (1) aged 6-17 years old;&#xD;
  &#xD;
            -  (2) diagnosed with asthma according to the Global Initiative for Asthma (GINA) 2020&#xD;
               guideline;&#xD;
  &#xD;
            -  (3) children and their caregivers are informed and voluntarily join the database and&#xD;
               had follow up for at least 1 year.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  (1) Patients with cystic fibrosis;&#xD;
  &#xD;
            -  (2) had mechanical airway obstruction, or any other pulmonary disease;&#xD;
  &#xD;
            -  (3) whose parents or legal guardians were not able to fill in the questionnaires.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Children's Hospital of Fudan University</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>201102</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Asthma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024902
  org study id: 2023-002
  nct id: NCT06024902
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Asthma remains a serious health problem with increasing prevalence and incidence. There is
        limited information about severe asthma among Chinese pediatric patients. In this context, we
        decided to explore the clinical characteristics and risk factors of severe asthma in
        children. This is a descriptive, observational, retrospective cohort study in children with
        asthma.
  
        The purpose of this retrospective study is: to determine the clinical characteristics of
        severe asthma of children; to identify the factors associated with severe childhood asthma.
  Asthma remains a serious health problem with increasing prevalence and incidence. There is
        limited information about severe asthma among Chinese pediatric patients. In this context, we
        decided to explore the clinical characteristics and risk factors of severe asthma in
        children. This is a descriptive, observational, retrospective cohort study in children with
        asthma.
  
        The purpose of this retrospective study is: to determine the clinical characteristics of
        severe asthma of children; to identify the factors associated with severe childhood asthma.
  
        Participants were consecutively recruited from asthma clinics between January 2021 and
        December 2021 at Children's Hospital of Fudan University. Patients fulfilling the following
        criteria were eligible for inclusion: (1) aged 6-17 years old; (2) diagnosed with asthma
        according to the Global Initiative for Asthma (GINA) 2020 guideline; (3) children and their
        caregivers are informed and voluntarily join the database and had follow up for at least 1
        year. Patients who had cystic fibrosis, mechanical airway obstruction, or any other pulmonary
        disease or whose parents or legal guardians were not able to fill in the questionnaires were
        not enrolled.
  
        At baseline, the asthma specialist questioned each of the patient in the presence of their
        caregivers to ensure that they supplied accurate disease information and were included
        according to the criteria. The patients and their caregivers are asked to complete the online
        questionnaires including the demographic; baseline asthma control, triggers, exacerbation,
        medication and adherence; environmental exposure, and diagnosis and control of comorbidities,
        etc. If a patient had poorly controlled comorbidities, multidisciplinary consultation would
        be recommended. Clinical assessments were arranged at baseline, 3, 6, 9, and 12 months.
  observational model: Cohort
  time perspective: Retrospective
  measure: Severity of asthma
  time frame: 12 months
  description: The severity of asthma was comprehensively estimated by a pediatric pulmonologist following the criteria of the Global Initiative for Asthma (GINA) 2021 when patients completed 12-months management.
  arm group label: childhood asthma
  description: Subjects with confirmed diagnosis of asthma without other lung disease followed for collection of demographic and clinical data.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 17 Years
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Asthma
  sharing ipd: No