<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/NCT03788330</url>
  </required_header>
  <id_info>
    <org_study_id>XFGY001</org_study_id>
    <nct_id>NCT03788330</nct_id>
  </id_info>
  <brief_title>Short-term Health Benefits of Using Fresh Air Filtration System in Classroom</brief_title>
  <official_title>Effects of Fresh Air Filtration System on Indoor Air Quality and Children's Health in Shanghai Schools</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>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>
      A randomized crossover trial will be conducted in 90 primary school children in 3 classrooms&#xD;
      in Shanghai, China. The effects of fresh air ventilation/filtration system, fresh air&#xD;
      ventilation system with no filtration and natual ventilation will be compared on the effects&#xD;
      of reducing indoor PM2.5 and chilhood health. Biological samples of children are going to be&#xD;
      collected to investigate the associations between indoor air pollution and biomarkes of&#xD;
      certain health effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized crossover trial among 90 primary students in 3 classrooms in Shanghai, China&#xD;
      will be performed. Three arms are going to be 1) fresh air filtration system, 2) fresh air&#xD;
      system with no filtration and 3) natural ventilation. Each arm is going to be in use for five&#xD;
      continuous weekdays followed by one week of wash-out. After one-week of wash out, a cross&#xD;
      over change between 3 arms is going to be taked. Then the 2nd week of intervention is&#xD;
      performed followed by the 2nd wash-out week. The same cross-over change between 3 arms is&#xD;
      going to be repeated again until each classroom will be applied by all three arms of&#xD;
      ventilation. A total of 5 weeks is required for the project. Children's biological samples&#xD;
      including saliva, urine and skin samples will be collected as well as exhaled NO. A&#xD;
      questionnaire on children's perception on air quality will be assessed as well.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2018</start_date>
  <completion_date type="Actual">January 22, 2019</completion_date>
  <primary_completion_date type="Actual">January 20, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exhaled nitric oxide</measure>
    <time_frame>within 2 hours of the end of intervention in each week</time_frame>
    <description>Airway inflammation biomarker</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxidative stress biomarkers</measure>
    <time_frame>within 2 hours of the end of intervention in each week</time_frame>
    <description>The level of lysozyme, cortisone and SIgA will be assessed in saliva and other oxidative biomarkers in the urine samples in children.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sick building symdrom</measure>
    <time_frame>within 2 hours of the end of intervention in each week</time_frame>
    <description>Answering questionnaire on sick biulding symdrom</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Airway Morbidity</condition>
  <condition>Cognitive and Attention Disorders and Disturbances</condition>
  <condition>Oxidative Stress</condition>
  <arm_group>
    <arm_group_label>Fresh air system with filtration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A fresh air ventilation system combined with PM2.5 filtration is applied in one primary school classroom.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fresh air system with no filtration</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A fresh air ventilation system with no PM2.5 filtration is applied in a parallel classroom.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Natural ventilation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Natural ventilation system was applied in the 3rd classroom as normal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fresh air system with filtration</intervention_name>
    <description>Using fresh air ventilation combined with PM2.5 filtration system to reduce the indoor PM2.5 concentration in primarty school classrooms</description>
    <arm_group_label>Fresh air system with filtration</arm_group_label>
    <arm_group_label>Fresh air system with no filtration</arm_group_label>
    <other_name>mechanical ventilation and filtration system</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All invited primary school children in Grade 5 in an artibrarily selected school&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current airway symptoms (cough, airway infection, asthma et al.)&#xD;
&#xD;
          -  Acute infectious diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhuohui Zhao, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fudan University</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>March 28, 2019</last_update_submitted>
  <last_update_submitted_qc>March 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Zhuohui Zhao</investigator_full_name>
    <investigator_title>Investigation director</investigator_title>
  </responsible_party>
  <keyword>exhaled nitric oxide</keyword>
  <keyword>Sick building syndrome</keyword>
  <keyword>indoor air</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognition Disorders</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/NCT03788330
org study id: XFGY001
nct id: NCT03788330
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A randomized crossover trial will be conducted in 90 primary school children in 3 classrooms
      in Shanghai, China. The effects of fresh air ventilation/filtration system, fresh air
      ventilation system with no filtration and natual ventilation will be compared on the effects
      of reducing indoor PM2.5 and chilhood health. Biological samples of children are going to be
      collected to investigate the associations between indoor air pollution and biomarkes of
      certain health effects.
A randomized crossover trial among 90 primary students in 3 classrooms in Shanghai, China
      will be performed. Three arms are going to be 1) fresh air filtration system, 2) fresh air
      system with no filtration and 3) natural ventilation. Each arm is going to be in use for five
      continuous weekdays followed by one week of wash-out. After one-week of wash out, a cross
      over change between 3 arms is going to be taked. Then the 2nd week of intervention is
      performed followed by the 2nd wash-out week. The same cross-over change between 3 arms is
      going to be repeated again until each classroom will be applied by all three arms of
      ventilation. A total of 5 weeks is required for the project. Children's biological samples
      including saliva, urine and skin samples will be collected as well as exhaled NO. A
      questionnaire on children's perception on air quality will be assessed as well.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Exhaled nitric oxide
time frame: within 2 hours of the end of intervention in each week
description: Airway inflammation biomarker
measure: Oxidative stress biomarkers
time frame: within 2 hours of the end of intervention in each week
description: The level of lysozyme, cortisone and SIgA will be assessed in saliva and other oxidative biomarkers in the urine samples in children.
measure: Sick building symdrom
time frame: within 2 hours of the end of intervention in each week
description: Answering questionnaire on sick biulding symdrom
arm group label: Fresh air system with filtration
arm group type: Experimental
description: A fresh air ventilation system combined with PM2.5 filtration is applied in one primary school classroom.
arm group label: Fresh air system with no filtration
arm group type: Placebo Comparator
description: A fresh air ventilation system with no PM2.5 filtration is applied in a parallel classroom.
arm group label: Natural ventilation
arm group type: No Intervention
description: Natural ventilation system was applied in the 3rd classroom as normal.
intervention type: Device
intervention name: Fresh air system with filtration
description: Using fresh air ventilation combined with PM2.5 filtration system to reduce the indoor PM2.5 concentration in primarty school classrooms
arm group label: Fresh air system with filtration
arm group label: Fresh air system with no filtration
other name: mechanical ventilation and filtration system
criteria: 
gender: All
minimum age: 10 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zhuohui Zhao, Dr
role: Study Chair
affiliation: Fudan University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Zhuohui Zhao
investigator title: Investigation director
mesh term: Cognition Disorders
sharing ipd: No