<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/NCT02239744</url>
  </required_header>
  <id_info>
    <org_study_id>FDUEH-1</org_study_id>
    <nct_id>NCT02239744</nct_id>
  </id_info>
  <brief_title>Intervention Study on the Health Impact of Air Filters in Chinese Adults</brief_title>
  <official_title>Cardiopulmonary Benefits of Reducing Indoor Particles of Outdoor Origin: a Randomized Double-blind Crossover Trial of Air Purifiers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to evaluate whether a short-term indoor air purifier intervention improves&#xD;
      cardiopulmonary health based on a randomized double-blind crossover trial&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We conducted a randomized double-blind crossover trial among 35 healthy college students in&#xD;
      Shanghai, China in 2014. These students lived in dormitories that were randomized into two&#xD;
      groups and alternated the use of true or sham air purifiers for 48 hours with a 2-week&#xD;
      wash-out interval.All participants and research staff were blinded to the group assignment.&#xD;
      We requested all participants to stay in their dormitory room with the windows/doors closed&#xD;
      throughout each 48-hour intervention period. We delivered foods and drinks to each room&#xD;
      during the intervention period. All interventions started at 8 a.m. to avoid issues related&#xD;
      to diurnal variation. We evaluated health endpoints and drew blood immediately after the&#xD;
      completion of each 48-hour intervention. We measured 14 circulating biomarkers of&#xD;
      inflammation, coagulation and vasoconstriction, lung function, blood pressure (BP), and&#xD;
      fractional exhaled nitric oxide (FeNO).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Circulating Biomarkers</measure>
    <time_frame>Blood samples were drawn within one hour after the intervention, and lab analysis was completed in the next 10 days</time_frame>
    <description>Peripheral blood samples (5 ml) were drawn by a nurse, separated into serum and plasma, and stored at -80 ℃ within 30 minutes. We measured the levels of 14 circulating biomarkers: (1) 8 biomarkers of inflammation, including C-reactive protein (CRP), fibrinogen, P-selection, monocyte chemoattractant protein-1 (MCP-1), interleukin-1b, interleukin-6, tumor necrosis factor-α (TNF-α) and myeloperoxidase; (2) 4 biomarkers of coagulation, including soluble CD40 ligand (sCD40L), plasminogen activator inhibitor-1, tissue plasminogen activator and D-Dimer; and (3) 2 biomarkers of vasoconstriction, including endothelin-1 and angiotensin-converting enzyme.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lung Function</measure>
    <time_frame>Within 1 hour after the end of the two-day intervention</time_frame>
    <description>A respiratory physician measured forced vital capacity, forced expiratory volume in 1 second and peak expiratory flow of each participant using the JAEGER Masterlab equipment (Würzburg, Germany) that meets the American Thoracic Society criteria. The volume signal was calibrated at least once on a testing day with a 3.0 L syringe connected to the pneumotachograph in accordance with the manufacturers' recommendations. We instructed participants to perform at least three forced expiratory lung function maneuvers in order to obtain a minimum of two acceptable and reproducible values, and we recorded the best results.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>Within one hour after the 2-day intervention</time_frame>
    <description>After sitting in a quiet room for at least 5 min, participants had their left upper arm BP measured by trained technicians using a mercury sphygmomanometer at least three times with 2-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP and diastolic BP. Pulse pressure was calculated as the difference between systolic BP and diastolic BP. If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements were arranged.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fractional Exhaled Nitric Oxide</measure>
    <time_frame>within 1 hour after the two-day intervention</time_frame>
    <description>FeNO is an established biomarker of respiratory inflammation, and has been widely used in epidemiological studies because of its high sensitivity, specificity and non-invasive nature. We measured FeNO levels using a portable NIOX MINO machine (Aerocrine AB, Solna, Sweden) according to standardized procedures by the American Thoracic Society and the European Respiratory Society.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Inflammation</condition>
  <condition>Coagulation</condition>
  <condition>Blood Pressure</condition>
  <condition>Pulmonary Function</condition>
  <arm_group>
    <arm_group_label>True air purification</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One group of subjects used an intervention of true air purifiers placed in the center of the room.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham air purification</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>This group of subjects used an intervention of sham air purifiers under the same conditions with true purifiers with the only difference being removal of the filter gauze in the sham purifiers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Air purifiers</intervention_name>
    <description>The 10 dormitory rooms were randomized into two groups of 5 rooms each. One group used an air purifier placed in the center of the room for 48 hours corresponding to one weekend, followed by a 2-week washout period, and another 48 hours of using a sham air purifier under the same conditions. The other group simply reversed the order in which the real and sham air purifiers were used. All rooms used the same qualified air purifiers (model FAP04, 3M Filtrete), with the only difference being removal of the filter gauze in the sham purifiers. The air pollution auto-sensing feature of air purifiers was disabled in both groups. All participants and research staff were blinded to the group assignment. We requested all participants to stay in their dormitory room with the windows/doors closed throughout each 48-hour intervention period.</description>
    <arm_group_label>Sham air purification</arm_group_label>
    <arm_group_label>True air purification</arm_group_label>
    <other_name>Air filtration</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy college students aged between 18 and 26&#xD;
&#xD;
          -  All the subjects should stay indoor almost the entire time, and stayed within the&#xD;
             central urban area of shanghai during the wash-out period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current smokers or ever smokers&#xD;
&#xD;
          -  chronic respiratory diseases&#xD;
&#xD;
          -  chronic cardiovascular diseases&#xD;
&#xD;
          -  acute infections&#xD;
&#xD;
          -  medication use in recent one month&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haidong Kan, PhD</last_name>
    <role>Study Director</role>
    <affiliation>School of Public Health，Fudan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Environmental Health, School of Public Health, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 7, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <results_first_submitted>November 19, 2014</results_first_submitted>
  <results_first_submitted_qc>November 26, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 1, 2014</results_first_posted>
  <last_update_submitted>January 12, 2016</last_update_submitted>
  <last_update_submitted_qc>January 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Haidong Kan</investigator_full_name>
    <investigator_title>PhD and Professor</investigator_title>
  </responsible_party>
  <keyword>air pollution</keyword>
  <keyword>air purification</keyword>
  <keyword>intervention</keyword>
  <keyword>randomized controlled trial</keyword>
  <keyword>cardiovascular health</keyword>
  <keyword>pulmonary health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>We recruited 35 healthy college students.</recruitment_details>
      <pre_assignment_details>We recruited 35 healthy college students and no one were excluded according to the exclusion criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Sham Purifiers First, Then True Purifiers</title>
          <description>The 10 rooms were randomized into two groups of 5 rooms each. In the first period, this group used sham air purifiers with the only difference being removal of the filter gauze. In the second period, this group used true air purifiers.</description>
        </group>
        <group group_id="P2">
          <title>True Purifiers First, Then Sham Purifiers</title>
          <description>The 10 rooms were randomized into two groups of 5 rooms each. In the first period, this group used true air purifiers.In the second period, this group used sham air purifiers.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All 35 participants recivered palecbo and real intervention, and the order was random. This crossover study autonomically allows each subject to serve as his or her own control over time.</population>
      <group_list>
        <group group_id="B1">
          <title>Sham Purifiers</title>
          <description>The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze.</description>
        </group>
        <group group_id="B2">
          <title>True Purifiers</title>
          <description>The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="17"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="35"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>We recruited all participants from the Fenglin campus of Fudan University. Therefore, all these students are young adult whose age was nearly 23 years old.</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24" spread="2"/>
                    <measurement group_id="B2" value="21" spread="2"/>
                    <measurement group_id="B3" value="23" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>Kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21" spread="2.5"/>
                    <measurement group_id="B2" value="22" spread="2.5"/>
                    <measurement group_id="B3" value="22" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Circulating Biomarkers</title>
        <description>Peripheral blood samples (5 ml) were drawn by a nurse, separated into serum and plasma, and stored at -80 ℃ within 30 minutes. We measured the levels of 14 circulating biomarkers: (1) 8 biomarkers of inflammation, including C-reactive protein (CRP), fibrinogen, P-selection, monocyte chemoattractant protein-1 (MCP-1), interleukin-1b, interleukin-6, tumor necrosis factor-α (TNF-α) and myeloperoxidase; (2) 4 biomarkers of coagulation, including soluble CD40 ligand (sCD40L), plasminogen activator inhibitor-1, tissue plasminogen activator and D-Dimer; and (3) 2 biomarkers of vasoconstriction, including endothelin-1 and angiotensin-converting enzyme.</description>
        <time_frame>Blood samples were drawn within one hour after the intervention, and lab analysis was completed in the next 10 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sham Purifiers</title>
            <description>The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze</description>
          </group>
          <group group_id="O2">
            <title>True Purifiers</title>
            <description>The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.</description>
          </group>
        </group_list>
        <measure>
          <title>Circulating Biomarkers</title>
          <description>Peripheral blood samples (5 ml) were drawn by a nurse, separated into serum and plasma, and stored at -80 ℃ within 30 minutes. We measured the levels of 14 circulating biomarkers: (1) 8 biomarkers of inflammation, including C-reactive protein (CRP), fibrinogen, P-selection, monocyte chemoattractant protein-1 (MCP-1), interleukin-1b, interleukin-6, tumor necrosis factor-α (TNF-α) and myeloperoxidase; (2) 4 biomarkers of coagulation, including soluble CD40 ligand (sCD40L), plasminogen activator inhibitor-1, tissue plasminogen activator and D-Dimer; and (3) 2 biomarkers of vasoconstriction, including endothelin-1 and angiotensin-converting enzyme.</description>
          <units>ng/ml</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C-reaction protein（CRP）</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="926.3" spread="1967.1"/>
                    <measurement group_id="O2" value="913.1" spread="1734.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fibrinogen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1122.2" spread="280.1"/>
                    <measurement group_id="O2" value="1108.2" spread="232.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>P-selection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139.0" spread="41.6"/>
                    <measurement group_id="O2" value="129.4" spread="39.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Soluble CD40L ligand（sCD40L）</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="1.6"/>
                    <measurement group_id="O2" value="0.5" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>plasminogen activator inhibitor-1（PAI-1）</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.9" spread="16.7"/>
                    <measurement group_id="O2" value="41.5" spread="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myeloperoxidase（MPO）</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1579.4" spread="772.0"/>
                    <measurement group_id="O2" value="1261.4" spread="659.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>D-Dimer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1174.6" spread="817.2"/>
                    <measurement group_id="O2" value="1001.2" spread="988.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Angiotensin-converting enzyme（ACE）</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102.9" spread="32.4"/>
                    <measurement group_id="O2" value="101.1" spread="31.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Blood Pressure</title>
        <description>After sitting in a quiet room for at least 5 min, participants had their left upper arm BP measured by trained technicians using a mercury sphygmomanometer at least three times with 2-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP and diastolic BP. Pulse pressure was calculated as the difference between systolic BP and diastolic BP. If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements were arranged.</description>
        <time_frame>Within one hour after the 2-day intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sham Purifiers</title>
            <description>The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze</description>
          </group>
          <group group_id="O2">
            <title>True Purifiers</title>
            <description>The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Pressure</title>
          <description>After sitting in a quiet room for at least 5 min, participants had their left upper arm BP measured by trained technicians using a mercury sphygmomanometer at least three times with 2-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP and diastolic BP. Pulse pressure was calculated as the difference between systolic BP and diastolic BP. If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements were arranged.</description>
          <units>mmHg</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106.0" spread="9.6"/>
                    <measurement group_id="O2" value="103.0" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.9" spread="8.6"/>
                    <measurement group_id="O2" value="67.9" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.8" spread="5.4"/>
                    <measurement group_id="O2" value="34.8" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lung Function</title>
        <description>A respiratory physician measured forced vital capacity, forced expiratory volume in 1 second and peak expiratory flow of each participant using the JAEGER Masterlab equipment (Würzburg, Germany) that meets the American Thoracic Society criteria. The volume signal was calibrated at least once on a testing day with a 3.0 L syringe connected to the pneumotachograph in accordance with the manufacturers' recommendations. We instructed participants to perform at least three forced expiratory lung function maneuvers in order to obtain a minimum of two acceptable and reproducible values, and we recorded the best results.</description>
        <time_frame>Within 1 hour after the end of the two-day intervention</time_frame>
        <population>Ultimately, all 35 participants completed this study.This crossover study autonomically allows each subject to serve as his or her own control over time.</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Purifiers</title>
            <description>The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze</description>
          </group>
          <group group_id="O2">
            <title>True Purifiers</title>
            <description>The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.</description>
          </group>
        </group_list>
        <measure>
          <title>Lung Function</title>
          <description>A respiratory physician measured forced vital capacity, forced expiratory volume in 1 second and peak expiratory flow of each participant using the JAEGER Masterlab equipment (Würzburg, Germany) that meets the American Thoracic Society criteria. The volume signal was calibrated at least once on a testing day with a 3.0 L syringe connected to the pneumotachograph in accordance with the manufacturers' recommendations. We instructed participants to perform at least three forced expiratory lung function maneuvers in order to obtain a minimum of two acceptable and reproducible values, and we recorded the best results.</description>
          <population>Ultimately, all 35 participants completed this study.This crossover study autonomically allows each subject to serve as his or her own control over time.</population>
          <units>L</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>forced vital capacity(FVC)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="0.7"/>
                    <measurement group_id="O2" value="3.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>forced expiratory volume in 1 s(FEV1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="0.5"/>
                    <measurement group_id="O2" value="2.8" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fractional Exhaled Nitric Oxide</title>
        <description>FeNO is an established biomarker of respiratory inflammation, and has been widely used in epidemiological studies because of its high sensitivity, specificity and non-invasive nature. We measured FeNO levels using a portable NIOX MINO machine (Aerocrine AB, Solna, Sweden) according to standardized procedures by the American Thoracic Society and the European Respiratory Society.</description>
        <time_frame>within 1 hour after the two-day intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sham Purifiers</title>
            <description>The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze.</description>
          </group>
          <group group_id="O2">
            <title>True Purifiers</title>
            <description>The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.</description>
          </group>
        </group_list>
        <measure>
          <title>Fractional Exhaled Nitric Oxide</title>
          <description>FeNO is an established biomarker of respiratory inflammation, and has been widely used in epidemiological studies because of its high sensitivity, specificity and non-invasive nature. We measured FeNO levels using a portable NIOX MINO machine (Aerocrine AB, Solna, Sweden) according to standardized procedures by the American Thoracic Society and the European Respiratory Society.</description>
          <units>ppb</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5" spread="25.1"/>
                    <measurement group_id="O2" value="13.3" spread="20.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>At the end of each 2-day period</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Sham Purifiers</title>
          <description>The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze.</description>
        </group>
        <group group_id="E2">
          <title>True Purifiers</title>
          <description>The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study only included 35 participants in 10 rooms, we might therefore have missed some potentially important but modest differences due to the relatively small sample size.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Haidong Kan</name_or_title>
      <organization>Department of Environmental Health, School of Public Health, Fudan University</organization>
      <phone>86-21-54237908</phone>
      <email>kanh@fudan.edu.cn</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02239744
org study id: FDUEH-1
nct id: NCT02239744
lead sponsor: 
has dmc: Yes
This study aimed to evaluate whether a short-term indoor air purifier intervention improves
      cardiopulmonary health based on a randomized double-blind crossover trial
We conducted a randomized double-blind crossover trial among 35 healthy college students in
      Shanghai, China in 2014. These students lived in dormitories that were randomized into two
      groups and alternated the use of true or sham air purifiers for 48 hours with a 2-week
      wash-out interval.All participants and research staff were blinded to the group assignment.
      We requested all participants to stay in their dormitory room with the windows/doors closed
      throughout each 48-hour intervention period. We delivered foods and drinks to each room
      during the intervention period. All interventions started at 8 a.m. to avoid issues related
      to diurnal variation. We evaluated health endpoints and drew blood immediately after the
      completion of each 48-hour intervention. We measured 14 circulating biomarkers of
      inflammation, coagulation and vasoconstriction, lung function, blood pressure (BP), and
      fractional exhaled nitric oxide (FeNO).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Circulating Biomarkers
time frame: Blood samples were drawn within one hour after the intervention, and lab analysis was completed in the next 10 days
description: Peripheral blood samples (5 ml) were drawn by a nurse, separated into serum and plasma, and stored at -80 ℃ within 30 minutes. We measured the levels of 14 circulating biomarkers: (1) 8 biomarkers of inflammation, including C-reactive protein (CRP), fibrinogen, P-selection, monocyte chemoattractant protein-1 (MCP-1), interleukin-1b, interleukin-6, tumor necrosis factor-α (TNF-α) and myeloperoxidase; (2) 4 biomarkers of coagulation, including soluble CD40 ligand (sCD40L), plasminogen activator inhibitor-1, tissue plasminogen activator and D-Dimer; and (3) 2 biomarkers of vasoconstriction, including endothelin-1 and angiotensin-converting enzyme.
measure: Lung Function
time frame: Within 1 hour after the end of the two-day intervention
description: A respiratory physician measured forced vital capacity, forced expiratory volume in 1 second and peak expiratory flow of each participant using the JAEGER Masterlab equipment (Würzburg, Germany) that meets the American Thoracic Society criteria. The volume signal was calibrated at least once on a testing day with a 3.0 L syringe connected to the pneumotachograph in accordance with the manufacturers' recommendations. We instructed participants to perform at least three forced expiratory lung function maneuvers in order to obtain a minimum of two acceptable and reproducible values, and we recorded the best results.
measure: Blood Pressure
time frame: Within one hour after the 2-day intervention
description: After sitting in a quiet room for at least 5 min, participants had their left upper arm BP measured by trained technicians using a mercury sphygmomanometer at least three times with 2-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP and diastolic BP. Pulse pressure was calculated as the difference between systolic BP and diastolic BP. If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements were arranged.
measure: Fractional Exhaled Nitric Oxide
time frame: within 1 hour after the two-day intervention
description: FeNO is an established biomarker of respiratory inflammation, and has been widely used in epidemiological studies because of its high sensitivity, specificity and non-invasive nature. We measured FeNO levels using a portable NIOX MINO machine (Aerocrine AB, Solna, Sweden) according to standardized procedures by the American Thoracic Society and the European Respiratory Society.
arm group label: True air purification
arm group type: Experimental
description: One group of subjects used an intervention of true air purifiers placed in the center of the room.
arm group label: Sham air purification
arm group type: Sham Comparator
description: This group of subjects used an intervention of sham air purifiers under the same conditions with true purifiers with the only difference being removal of the filter gauze in the sham purifiers.
intervention type: Behavioral
intervention name: Air purifiers
description: The 10 dormitory rooms were randomized into two groups of 5 rooms each. One group used an air purifier placed in the center of the room for 48 hours corresponding to one weekend, followed by a 2-week washout period, and another 48 hours of using a sham air purifier under the same conditions. The other group simply reversed the order in which the real and sham air purifiers were used. All rooms used the same qualified air purifiers (model FAP04, 3M Filtrete), with the only difference being removal of the filter gauze in the sham purifiers. The air pollution auto-sensing feature of air purifiers was disabled in both groups. All participants and research staff were blinded to the group assignment. We requested all participants to stay in their dormitory room with the windows/doors closed throughout each 48-hour intervention period.
arm group label: Sham air purification
arm group label: True air purification
other name: Air filtration
criteria: 
gender: All
minimum age: 18 Years
maximum age: 26 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Haidong Kan, PhD
role: Study Director
affiliation: School of Public Health，Fudan University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Haidong Kan
investigator title: PhD and Professor
mesh term: Inflammation
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study only included 35 participants in 10 rooms, we might therefore have missed some potentially important but modest differences due to the relatively small sample size.
point of contact: 