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/NCT05992389</url>
    </required_header>
    <id_info>
      <org_study_id>SCH-EU101057497</org_study_id>
      <nct_id>NCT05992389</nct_id>
    </id_info>
    <brief_title>Evidence Driven Indoor Air Quality Improvement</brief_title>
    <official_title>Evidence Driven Indoor Air Quality Improvement</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Hospital Srebrnjak</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Children's Hospital Srebrnjak</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>
        The aim is to identify the underlying disease mechanisms driving specific asthma phenotypes&#xD;
        as well as certain disease outcomes and their relation to impaired indoor air quality. This&#xD;
        may also help in underpinning specific target mechanisms in order to personalize and improve&#xD;
        current treatment options in childhood asthma and develop more successful prevention&#xD;
        strategies. This will be done by combining data from detailed clinical phenotyping with&#xD;
        multiple -omics data.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A recent report from the European Environmental Agency (EEA) shows that as many as 417 000&#xD;
        deaths per year in large European cities are caused by long-term exposure to air pollution&#xD;
        (EEA 2018). Children are more sensitive to environmental risks than adults. Environmental&#xD;
        pollution (impaired air quality) has been linked to asthma development. Asthma is the most&#xD;
        common chronic disease in children, with estimations that one in every five children will&#xD;
        develop asthma during childhood. The effects of poor air quality most likely act&#xD;
        synergistically with other predisposing and environmental factors, and in a cumulative&#xD;
        manner. Additionally, asthma in children is considered to be a complex syndrome encompassing&#xD;
        a number of different disease subtypes (phenotypes) driven by distinct yet discrete&#xD;
        underlying pathophysiological mechanisms (endotypes). Detailed characterization of these&#xD;
        pheno- and endotypes in asthma, as well as disease and treatment outcomes resulting from them&#xD;
        still remain elusive.&#xD;
  &#xD;
        The modern way of life, especially in the light of the COVID-19 ('CO' stands for corona, 'VI'&#xD;
        for virus, 'D' for disease, and '19' for 2019 (year first identified)) pandemic, implies that&#xD;
        people spend up to 90% of our time indoors. Certain studies suggest that indoor air quality&#xD;
        may be significantly worse than outdoors and the regulation of indoor air quality falls much&#xD;
        behind the legislative and guidelines in outdoor air quality. It is reasonable to believe&#xD;
        that indoor air quality affects human health (risk for allergy, asthma, and specific disease&#xD;
        subtypes) at least as much as outdoor pollutants, if not more.&#xD;
  &#xD;
        For the Evidence Driven Indoor Air Quality Improvement Srebrnjak Children's Hospital (EDIAQI&#xD;
        SCH 2021) cohort, 200 school aged children (6-14 years) from the Croatian capital and its&#xD;
        surroundings (Zagreb) will be recruited to this study from the outpatient clinic at the&#xD;
        Srebrnjak Children's Hospital (SCH) in Zagreb, Croatia, which is the national Referral Centre&#xD;
        of the Croatian Ministry of Health for Clinical Allergology in children.&#xD;
  &#xD;
        150 of them with the diagnosed asthma and 50 participants their matching control,&#xD;
        non-asthmatic subjects.&#xD;
  &#xD;
        Following an expert (physician, experienced allergy/pulmonology specialist) confirmed&#xD;
        diagnosis of asthma and after obtaining an informed consent from the children's&#xD;
        caregivers/children themselves (according to local legislative), participants undergo a&#xD;
        standard battery of diagnostic tests, examinations and procedures as a part of their routine&#xD;
        asthma management plan. This study will also involve clinical follow-up visits (approximately&#xD;
        every 3-6 months, according to Global Initiative for Asthma (GINA) guidelines). As a part of&#xD;
        this research, certain biological samples (blood, exhaled breath condensate, induced sputum)&#xD;
        will be collected both at baseline and follow-up visits, aiming at using biological samples&#xD;
        left over from routine diagnostics whenever possible and using minimally invasive methods at&#xD;
        all times.&#xD;
  &#xD;
        The study will include visits:&#xD;
  &#xD;
          1. Initial (screening) visit (First patient first visit- V0 +3 months): written consent,&#xD;
             assessment of inclusion and exclusion criteria, physical examination, anthropometric&#xD;
             measurements, skin prick test (SPT), Specific Immunoglobulin E (sIgE) (+ISAC), Atopy&#xD;
             patch test (APT), spirometry, fractional exhaled nitric oxide (FENO), questionnaires,&#xD;
             blood sampling, buccal cells swabs, exhaled breath condensate (EBC), induced sputum&#xD;
  &#xD;
          2. First follow-up visit- V1 (V0 + 3-6 months): questionnaires, spirometry, FENO,&#xD;
             anthropometric measurements, asthma control assessment&#xD;
  &#xD;
          3. Second follow-up visit- V2 (V0 + 6-12 months): questionnaires, spirometry, FENO,&#xD;
             anthropometric measurements, asthma control assessment&#xD;
  &#xD;
          4. Third follow-up visit- V3 (V0 + 9-18 - months): questionnaires, spirometry, FENO,&#xD;
             anthropometric measurements, asthma control assessment&#xD;
  &#xD;
          5. Fourth follow-up visit (V0 + 21 months): questionnaires, spirometry, FENO,&#xD;
             anthropometric measurements, asthma control assessment&#xD;
  &#xD;
          6. Last visit (last patient last visit- V0 + 24 months): anthropometric measurements, SPT,&#xD;
             sIgE (+ISAC), APT, spirometry, FENO, questionnaires, blood sampling, buccal cells swabs,&#xD;
             EBC, induced sputum, asthma control assessment, final assessment of the study outcome&#xD;
             measures, check and document consumption, adherence, preventive measures.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 3, 2023</start_date>
    <completion_date type="Anticipated">April 2025</completion_date>
    <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in the number of asthma exacerbations and severity</measure>
      <time_frame>6 months</time_frame>
      <description>The exacerbation rate and exacerbation severity will be recorded along with the treatment use (reliever medication, use of oral and parenteral corticosteroids etc.) During the patient examination the questionnaire will be used to record the number of asthma exacerbations and the therapy used.&#xD;
  Asthmatic patients will be regularly controlled even more often in case of exacerbations.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change of asthma control</measure>
      <time_frame>6 months</time_frame>
      <description>Childhood Asthma Control Test (C-ACT) questionnaire will be used to tell us if the asthma treatment plan is optimal and if asthma is being properly controlled. For children 4 to 11 years maximal score is 27, and for those older then 12 years maximal score is 25. Higher scores reflect greater asthma control, and if the score is 19 or less may be a sign that asthma is not controlled as well as it could be.&#xD;
  Asthmatic patients will be regularly controlled even more often in case of exacerbations.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lung function tests</measure>
      <time_frame>6 months</time_frame>
      <description>Forced expiratory volume in one second (FEV1), Forced vital capacity (FVC) and the ratio of the two volumes (FEV1/FVC) will be recorded for each patient at each visit. Both FEV1 and FVC are measured in liters&#xD;
  FEV1 is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration.&#xD;
  Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.&#xD;
  Asthmatic patients will be regularly controlled even more often in case of exacerbations.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fractional exhaled nitric oxide (FeNO)</measure>
      <time_frame>6 months</time_frame>
      <description>FeNO test measures the level of nitric oxide gas in an exhaled sample of breath. It is measured in &quot;parts per billion&quot; (ppb).&#xD;
  Asthmatic patients will be regularly controlled even more often in case of exacerbations.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Use of controller medication</measure>
      <time_frame>6 months</time_frame>
      <description>Type and dose of controller medication wil be monitored and recorded. Asthmatic patients will be regularly controlled even more often in case of exacerbations.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Asthma in Children</condition>
    <condition>Pollution; Exposure</condition>
    <arm_group>
      <arm_group_label>Children with asthma</arm_group_label>
      <description>School aged participants (6-14 yrs) with an established diagnosis of asthma</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-asthmatic subjects (healthy control)</arm_group_label>
      <description>School aged participants (6-14 yrs), non-asthmatic subjects (negative history of allergic diseases)</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Total of 200 children will be recruited for this study. 150 school aged children with&#xD;
          asthma (6-14 years) from the Croatian capital and its surroundings (Zagreb) will be&#xD;
          recruited to this study. These participants will be recruited from the outpatient clinic at&#xD;
          the Srebrnjak Children's Hospital in Zagreb, Croatia, as well as matching control&#xD;
          participants (non-asthmatic subjects, N=50).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  school aged participants with asthma (patients with a clinical diagnosis of asthma&#xD;
               (according to European Respiratory Society (ERS) and American Thoracic Society (ATS)&#xD;
               guidelines) for at least a year , being on a stable dose of anti-inflammatory&#xD;
               treatment for at least one month with partially controlled or uncontrolled asthma&#xD;
               according to GINA guidelines)&#xD;
  &#xD;
            -  non-asthmatic school aged participants (matching control subjects)&#xD;
  &#xD;
            -  signed informed consent, .&#xD;
  &#xD;
            -  additional inclusion criteria include clinically significant allergy to indoor and&#xD;
               outdoor allergens, with positive skin prick test (SPT) and specific IgE levels (&gt;0.7&#xD;
               kUA/L) (UA = allergen-specific unit)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  known inborn or perinatal pulmonary disease;&#xD;
  &#xD;
            -  pulmonary malformation;&#xD;
  &#xD;
            -  oxygen therapy after birth with a duration of more than 24h;&#xD;
  &#xD;
            -  ventilator support or mechanical ventilation after birth;&#xD;
  &#xD;
            -  diagnosis of cystic fibrosis;&#xD;
  &#xD;
            -  primary ciliary dyskinesia;&#xD;
  &#xD;
            -  heart failure diagnosed after birth affecting pulmonary circulation;&#xD;
  &#xD;
            -  major respiratory diseases such as e.g. interstitial lung disease,&#xD;
  &#xD;
            -  acute respiratory infection at recruitment,&#xD;
  &#xD;
            -  use of systemic corticosteroids,&#xD;
  &#xD;
            -  recent asthma-related visit to emergency department (in the past three weeks)&#xD;
  &#xD;
            -  coexistence of other serious chronic illness. Moreover, children will be excluded from&#xD;
               study visits and biomaterial collection in the case of fever of at least 38.5°C during&#xD;
               the last two weeks prior to the planned visit.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>14 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mirjana Turkalj, Prof., MD</last_name>
      <phone>+38516391164</phone>
      <email>mturkalj@bolnica-srebrnjak.hr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Children's Hospital Srebrnjak</name>
        <address>
          <city>Zagreb</city>
          <zip>10000</zip>
          <country>Croatia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mirjana Turkalj, MD, PhD</last_name>
        <phone>+38516391164</phone>
        <email>mturkalj@bolnica-srebrnjak.hr</email>
      </contact>
      <investigator>
        <last_name>Mirjana Turkalj, Prof,MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Croatia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Children's Hospital Srebrnjak</investigator_affiliation>
      <investigator_full_name>Mirjana Turkalj, MD</investigator_full_name>
      <investigator_title>Professor, MD, PhD</investigator_title>
    </responsible_party>
    <keyword>indoor air quality</keyword>
    <keyword>asthma</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Asthma</mesh_term>
    </condition_browse>
    <!-- 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/NCT05992389
  org study id: SCH-EU101057497
  nct id: NCT05992389
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim is to identify the underlying disease mechanisms driving specific asthma phenotypes
        as well as certain disease outcomes and their relation to impaired indoor air quality. This
        may also help in underpinning specific target mechanisms in order to personalize and improve
        current treatment options in childhood asthma and develop more successful prevention
        strategies. This will be done by combining data from detailed clinical phenotyping with
        multiple -omics data.
  A recent report from the European Environmental Agency (EEA) shows that as many as 417 000
        deaths per year in large European cities are caused by long-term exposure to air pollution
        (EEA 2018). Children are more sensitive to environmental risks than adults. Environmental
        pollution (impaired air quality) has been linked to asthma development. Asthma is the most
        common chronic disease in children, with estimations that one in every five children will
        develop asthma during childhood. The effects of poor air quality most likely act
        synergistically with other predisposing and environmental factors, and in a cumulative
        manner. Additionally, asthma in children is considered to be a complex syndrome encompassing
        a number of different disease subtypes (phenotypes) driven by distinct yet discrete
        underlying pathophysiological mechanisms (endotypes). Detailed characterization of these
        pheno- and endotypes in asthma, as well as disease and treatment outcomes resulting from them
        still remain elusive.
  
        The modern way of life, especially in the light of the COVID-19 ('CO' stands for corona, 'VI'
        for virus, 'D' for disease, and '19' for 2019 (year first identified)) pandemic, implies that
        people spend up to 90% of our time indoors. Certain studies suggest that indoor air quality
        may be significantly worse than outdoors and the regulation of indoor air quality falls much
        behind the legislative and guidelines in outdoor air quality. It is reasonable to believe
        that indoor air quality affects human health (risk for allergy, asthma, and specific disease
        subtypes) at least as much as outdoor pollutants, if not more.
  
        For the Evidence Driven Indoor Air Quality Improvement Srebrnjak Children's Hospital (EDIAQI
        SCH 2021) cohort, 200 school aged children (6-14 years) from the Croatian capital and its
        surroundings (Zagreb) will be recruited to this study from the outpatient clinic at the
        Srebrnjak Children's Hospital (SCH) in Zagreb, Croatia, which is the national Referral Centre
        of the Croatian Ministry of Health for Clinical Allergology in children.
  
        150 of them with the diagnosed asthma and 50 participants their matching control,
        non-asthmatic subjects.
  
        Following an expert (physician, experienced allergy/pulmonology specialist) confirmed
        diagnosis of asthma and after obtaining an informed consent from the children's
        caregivers/children themselves (according to local legislative), participants undergo a
        standard battery of diagnostic tests, examinations and procedures as a part of their routine
        asthma management plan. This study will also involve clinical follow-up visits (approximately
        every 3-6 months, according to Global Initiative for Asthma (GINA) guidelines). As a part of
        this research, certain biological samples (blood, exhaled breath condensate, induced sputum)
        will be collected both at baseline and follow-up visits, aiming at using biological samples
        left over from routine diagnostics whenever possible and using minimally invasive methods at
        all times.
  
        The study will include visits:
  
          1. Initial (screening) visit (First patient first visit- V0 +3 months): written consent,
             assessment of inclusion and exclusion criteria, physical examination, anthropometric
             measurements, skin prick test (SPT), Specific Immunoglobulin E (sIgE) (+ISAC), Atopy
             patch test (APT), spirometry, fractional exhaled nitric oxide (FENO), questionnaires,
             blood sampling, buccal cells swabs, exhaled breath condensate (EBC), induced sputum
  
          2. First follow-up visit- V1 (V0 + 3-6 months): questionnaires, spirometry, FENO,
             anthropometric measurements, asthma control assessment
  
          3. Second follow-up visit- V2 (V0 + 6-12 months): questionnaires, spirometry, FENO,
             anthropometric measurements, asthma control assessment
  
          4. Third follow-up visit- V3 (V0 + 9-18 - months): questionnaires, spirometry, FENO,
             anthropometric measurements, asthma control assessment
  
          5. Fourth follow-up visit (V0 + 21 months): questionnaires, spirometry, FENO,
             anthropometric measurements, asthma control assessment
  
          6. Last visit (last patient last visit- V0 + 24 months): anthropometric measurements, SPT,
             sIgE (+ISAC), APT, spirometry, FENO, questionnaires, blood sampling, buccal cells swabs,
             EBC, induced sputum, asthma control assessment, final assessment of the study outcome
             measures, check and document consumption, adherence, preventive measures.
  observational model: Case-Control
  time perspective: Prospective
  measure: Change in the number of asthma exacerbations and severity
  time frame: 6 months
  description: The exacerbation rate and exacerbation severity will be recorded along with the treatment use (reliever medication, use of oral and parenteral corticosteroids etc.) During the patient examination the questionnaire will be used to record the number of asthma exacerbations and the therapy used.
  Asthmatic patients will be regularly controlled even more often in case of exacerbations.
  measure: Change of asthma control
  time frame: 6 months
  description: Childhood Asthma Control Test (C-ACT) questionnaire will be used to tell us if the asthma treatment plan is optimal and if asthma is being properly controlled. For children 4 to 11 years maximal score is 27, and for those older then 12 years maximal score is 25. Higher scores reflect greater asthma control, and if the score is 19 or less may be a sign that asthma is not controlled as well as it could be.
  Asthmatic patients will be regularly controlled even more often in case of exacerbations.
  measure: Lung function tests
  time frame: 6 months
  description: Forced expiratory volume in one second (FEV1), Forced vital capacity (FVC) and the ratio of the two volumes (FEV1/FVC) will be recorded for each patient at each visit. Both FEV1 and FVC are measured in liters
  FEV1 is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration.
  Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.
  Asthmatic patients will be regularly controlled even more often in case of exacerbations.
  measure: Fractional exhaled nitric oxide (FeNO)
  time frame: 6 months
  description: FeNO test measures the level of nitric oxide gas in an exhaled sample of breath. It is measured in "parts per billion" (ppb).
  Asthmatic patients will be regularly controlled even more often in case of exacerbations.
  measure: Use of controller medication
  time frame: 6 months
  description: Type and dose of controller medication wil be monitored and recorded. Asthmatic patients will be regularly controlled even more often in case of exacerbations.
  arm group label: Children with asthma
  description: School aged participants (6-14 yrs) with an established diagnosis of asthma
  arm group label: Non-asthmatic subjects (healthy control)
  description: School aged participants (6-14 yrs), non-asthmatic subjects (negative history of allergic diseases)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 14 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mirjana Turkalj, Prof., MD
  phone: +38516391164
  email: mturkalj@bolnica-srebrnjak.hr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Croatia
  responsible party type: Principal Investigator
  investigator affiliation: Children's Hospital Srebrnjak
  investigator full name: Mirjana Turkalj, MD
  investigator title: Professor, MD, PhD
  mesh term: Asthma