<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/NCT03017976</url>
  </required_header>
  <id_info>
    <org_study_id>NORTE-01-0145-FEDER-000010</org_study_id>
    <nct_id>NCT03017976</nct_id>
  </id_info>
  <brief_title>Swimming Pool Environment Impact on the Human Respiratory Health</brief_title>
  <acronym>SWAN</acronym>
  <official_title>Swan Study: Swimming Pool Environment Impact on the Human Respiratory Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade do Porto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade do Porto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to assess the influence of exposure to swimming pool environment on&#xD;
      respiratory symptoms and diseases, and on cancer outcomes among swimmers and swimming pool&#xD;
      attendants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives:&#xD;
&#xD;
        1. In relation to human exposure 1.1. To assess the levels of certain disinfection&#xD;
           by-products (DBPs) in blood and urine (biomarkers of exposure); 1.2. To assess swimming&#xD;
           induced changes in biomarkers of genotoxicity, specifically micronuclei (MN) in&#xD;
           exfoliated urothelial cells and buccal cells and DNA damage in peripheral blood&#xD;
           lymphocytes, urine mutagenicity and in exfoliated urothelial; 1.3. To assess the effects&#xD;
           of swimming pool exposure on oxidative stress and lung damage in swimming pool users;&#xD;
           1.4. To assess the impact of DBPs, including volatile DBPs on airway function,&#xD;
           inflammation and reactivity; 1.5. To assess the impact of swimming on skin&#xD;
           transepidermal water loss and dermal condition.&#xD;
&#xD;
        2. In relation to swimming pool environment 2.1. To assess water and air quality through&#xD;
           the analysis of several chemical (DBPs and other), physicochemical and microbiological&#xD;
           parameters and the associated short-term variation of their levels (hourly and daily);&#xD;
           2.2. To assess microbiological contamination of highly used surfaces; 2.3. To assess&#xD;
           mutagenicity of indoor chlorinated and brominated swimming pool water.&#xD;
&#xD;
      Methods&#xD;
&#xD;
      Study setting Chlorinated and brominated public indoor municipal swimming pools in the North&#xD;
      of Portugal.&#xD;
&#xD;
      Study design&#xD;
&#xD;
      This study will follow two distinct approaches:&#xD;
&#xD;
        1. A cross-sectional analysis to assess swimming pool physicochemical and microbiological&#xD;
           characteristics and the association between each parameter measured as an indicator of&#xD;
           water and air quality, contamination of surfaces and the health parameters assessed in&#xD;
           recreational users, swimming teachers and pool attendants.&#xD;
&#xD;
        2. An uncontrolled, before and after study to assess acute and chronic environmental&#xD;
           exposure effects on respiratory biomarkers of competitive swimmers:&#xD;
&#xD;
             1. Assessment of acute changes: regular competitive swimmers will be asked to swim for&#xD;
                40 minutes in a single, indoor, 50 m-long chlorinated swimming pool. Before and&#xD;
                after swimming, a battery of measurements will be assessed to evaluate respiratory&#xD;
                health biomarkers.&#xD;
&#xD;
             2. Assessment of chronic changes: regular and naïf competitive swimmers will be&#xD;
                followed for a mean period of 90 days. A battery of measurements and biological&#xD;
                samples will be collected at the baseline evaluation and 90 days after, in order to&#xD;
                evaluate long-term changes in respiratory health biomarkers.&#xD;
&#xD;
      Recruitment and data collection procedures&#xD;
&#xD;
        1. Cross-sectional study. The cross-sectional analysis will be performed in fifty municipal&#xD;
           indoor swimming pools in the North of Portugal on a voluntary basis. The administrative&#xD;
           boards of each swimming pool will be approached by the research team to present the&#xD;
           study's purposes and procedures and to obtain their consent to perform the study. Upon&#xD;
           acceptance, recreational users, swimming coaches/teachers and pool attendants will be&#xD;
           contacted and invited to participate. All subjects will receive a written description of&#xD;
           the study (appendix I-a) and the informed consent form (appendix II-a). Those who&#xD;
           provide an informed consent signed by both the subject and legal tutor (if a minor) will&#xD;
           be included in the study. Recreational swimmers, swimming teachers and pool attendants&#xD;
           will be asked to complete a self-administered standardized home questionnaire comprising&#xD;
           sociodemographic and health-related information, with a major focus on respiratory&#xD;
           health. Participants will also be asked to provide information on their food&#xD;
           consumption, physical activity levels and psychological well-being. Subjects should&#xD;
           return the completed questionnaires at the swimming pool facilities. A medical&#xD;
           examination will also be performed by trained health professionals and will include&#xD;
           anthropometric measurements, blood pressure evaluation, urine sample collection, skin&#xD;
           prick testing, exhaled breath condensate collection, lung function evaluation by&#xD;
           spirometry with bronchodilation, in a period conveniently scheduled with the&#xD;
           participating subjects.&#xD;
&#xD;
           The assessment of swimming pool chemical (DBPs and others), physicochemical and&#xD;
           microbiological characteristics will include sampling in the water, air and eventually&#xD;
           selected surfaces, that include: pool edges, stairs and starting blocks, floors (pool&#xD;
           and bathhouse), walls (concrete and glass of the pool and bathhouse) and highly touched&#xD;
           surfaces such as bathhouse benches. We will measure different chemical, physicochemical&#xD;
           and microbiological parameters in multiple locations within the pool structure in order&#xD;
           to characterize the exposure and its spatial and temporal distribution both within a&#xD;
           specific swimming pool and also between the different swimming pools studied.&#xD;
&#xD;
        2. Uncontrolled, before and after study. A single, indoor, 50-meter-long chlorinated&#xD;
           swimming pool in Porto, Portugal, will be selected for this study. The administrative&#xD;
           board will be approached by the research team to present the study's purposes and&#xD;
           procedures and to obtain their consent to perform the study. Upon acceptance, the&#xD;
           competitive swimming team will be asked to participate in the study. All subjects will&#xD;
           receive a written description of the study (appendix I-b) and the informed consent form&#xD;
           (appendix II-b). Competitive swimmers with 12 years of age or older who provide an&#xD;
           informed consent signed by both the subject and legal tutor (if a minor) will be&#xD;
           included in an uncontrolled before and after study to assess acute and chronic&#xD;
           respiratory symptoms after a regular training session. This assessment will be executed&#xD;
           following two approaches:&#xD;
&#xD;
             1. Assessment of acute changes: in a period conveniently scheduled with the swimmers&#xD;
                and their coaches, a medical examination will be performed in order to assess&#xD;
                baseline respiratory biomarkers of competitive swimmers. This examination will&#xD;
                include the assessment of exhaled breath condensate and lung function evaluation.&#xD;
                The same biological measurements will be performed after a single regular training&#xD;
                session and an interviewer-administered questionnaire will be applied.&#xD;
&#xD;
             2. Assessment of chronic changes: Competitive swimmers will also be followed through a&#xD;
                90-day period in order to evaluate long-term changes in respiratory and cancer&#xD;
                biomarkers. The baseline evaluation will consist in the assessment of biological&#xD;
                measurements, namely anthropometric measurements, blood pressure evaluation, sample&#xD;
                collection (i.e. blood and urine samples and buccal swab), skin prick testing,&#xD;
                pupillometry, capsaicin challenge, exhaled breath condensate collection, lung&#xD;
                function evaluation (namely, spirometry with bronchodilation, impulse oscillometry,&#xD;
                methacholine challenge and fractional concentration of orally exhaled nitric oxide)&#xD;
                and transepidermal water loss assessment. Participants will also be asked to&#xD;
                provide information on sociodemographic characteristics, personal and family&#xD;
                history of disease, use of medication, frequency of self-reported respiratory,&#xD;
                ocular and cutaneous symptoms, data on health-related behaviors, namely tobacco&#xD;
                use, physical activity levels and food consumption, through an&#xD;
                interviewer-administered questionnaire. A full examination will be performed only&#xD;
                at baseline and at the follow-up assessment (90 days after).&#xD;
&#xD;
      This evaluation will be performed by trained health professionals in a room inside the&#xD;
      swimming pool facilities but separated from the swimming pool area, in a period conveniently&#xD;
      scheduled with the swimmers and their coaches. Due to the possibility of experiencing&#xD;
      transient symptoms, participants will be asked to visit the research department in order to&#xD;
      perform the methacholine challenge. Participants will be reimbursed for any travel expenses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Spirometry with bronchodilation</measure>
    <time_frame>First week after recruitment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Airway resistance measurement</measure>
    <time_frame>First week after recruitment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Airway reactance measurement</measure>
    <time_frame>First week after recruitment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fractional concentration of orally exhaled nitric oxide</measure>
    <time_frame>First week after recruitment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Volatile organic compounds in the exhaled breath condensate</measure>
    <time_frame>First week after recruitment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnosis of immunoglobulin E (IgE) mediated allergies by skin prick testing</measure>
    <time_frame>First week after recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomic nervous system function assessment by pupillometry</measure>
    <time_frame>First week after recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transepidermal water loss</measure>
    <time_frame>First week after recruitment</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Asthma</condition>
  <condition>Lung Disease</condition>
  <condition>Genotoxicity</condition>
  <arm_group>
    <arm_group_label>Competitive swimmers</arm_group_label>
    <description>Regular and naïf competitive swimmers will be followed for a mean period of 90 days. A battery of measurements and biological samples will be collected at the baseline evaluation and 90 days after, in order to evaluate long-term changes in respiratory health biomarkers. Measurements will also be performed before and after a single regular training session in order to assess acute effects in respiratory health biomarkers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recreational swimmers and swimming pool staff</arm_group_label>
    <description>Swimming pool physicochemical and microbiological characteristics and the association between each parameter measured as an indicator of water and air quality, contamination of surfaces will be evaluated and the association with recreational users, swimming teachers and pool attendants health parameters will be studied.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Exhaled breath condensate (no DNA) Blood (DNA) Urine (DNA)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Competitive swimmers, recreational users and swimming pool workers attending chlorinated&#xD;
        and brominated public indoor municipal swimming pools in the North of Portugal.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Competitive swimmers, recreational swimmers or pool workers of a participating indoor&#xD;
        swimming pool; Individuals with 12 years of age or older; Individuals who provide (or their&#xD;
        caregivers) a signed informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Medicine of Porto University</name>
      <address>
        <city>Porto</city>
        <zip>4200-319</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <contact>
      <last_name>André Moreira, MD, PhD</last_name>
      <phone>00351932730090</phone>
      <email>andremoreira@med.up.pt</email>
    </contact>
    <contact_backup>
      <last_name>Vânia Mendes, MSc</last_name>
      <phone>00351918567504</phone>
      <email>vaniamendes@med.up.pt</email>
    </contact_backup>
    <investigator>
      <last_name>André Moreira, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</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>Lung Diseases</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/NCT03017976
org study id: NORTE-01-0145-FEDER-000010
nct id: NCT03017976
lead sponsor: 
has dmc: No
This study aims to assess the influence of exposure to swimming pool environment on
      respiratory symptoms and diseases, and on cancer outcomes among swimmers and swimming pool
      attendants.
Objectives:

        1. In relation to human exposure 1.1. To assess the levels of certain disinfection
           by-products (DBPs) in blood and urine (biomarkers of exposure); 1.2. To assess swimming
           induced changes in biomarkers of genotoxicity, specifically micronuclei (MN) in
           exfoliated urothelial cells and buccal cells and DNA damage in peripheral blood
           lymphocytes, urine mutagenicity and in exfoliated urothelial; 1.3. To assess the effects
           of swimming pool exposure on oxidative stress and lung damage in swimming pool users;
           1.4. To assess the impact of DBPs, including volatile DBPs on airway function,
           inflammation and reactivity; 1.5. To assess the impact of swimming on skin
           transepidermal water loss and dermal condition.

        2. In relation to swimming pool environment 2.1. To assess water and air quality through
           the analysis of several chemical (DBPs and other), physicochemical and microbiological
           parameters and the associated short-term variation of their levels (hourly and daily);
           2.2. To assess microbiological contamination of highly used surfaces; 2.3. To assess
           mutagenicity of indoor chlorinated and brominated swimming pool water.

      Methods

      Study setting Chlorinated and brominated public indoor municipal swimming pools in the North
      of Portugal.

      Study design

      This study will follow two distinct approaches:

        1. A cross-sectional analysis to assess swimming pool physicochemical and microbiological
           characteristics and the association between each parameter measured as an indicator of
           water and air quality, contamination of surfaces and the health parameters assessed in
           recreational users, swimming teachers and pool attendants.

        2. An uncontrolled, before and after study to assess acute and chronic environmental
           exposure effects on respiratory biomarkers of competitive swimmers:

             1. Assessment of acute changes: regular competitive swimmers will be asked to swim for
                40 minutes in a single, indoor, 50 m-long chlorinated swimming pool. Before and
                after swimming, a battery of measurements will be assessed to evaluate respiratory
                health biomarkers.

             2. Assessment of chronic changes: regular and naïf competitive swimmers will be
                followed for a mean period of 90 days. A battery of measurements and biological
                samples will be collected at the baseline evaluation and 90 days after, in order to
                evaluate long-term changes in respiratory health biomarkers.

      Recruitment and data collection procedures

        1. Cross-sectional study. The cross-sectional analysis will be performed in fifty municipal
           indoor swimming pools in the North of Portugal on a voluntary basis. The administrative
           boards of each swimming pool will be approached by the research team to present the
           study's purposes and procedures and to obtain their consent to perform the study. Upon
           acceptance, recreational users, swimming coaches/teachers and pool attendants will be
           contacted and invited to participate. All subjects will receive a written description of
           the study (appendix I-a) and the informed consent form (appendix II-a). Those who
           provide an informed consent signed by both the subject and legal tutor (if a minor) will
           be included in the study. Recreational swimmers, swimming teachers and pool attendants
           will be asked to complete a self-administered standardized home questionnaire comprising
           sociodemographic and health-related information, with a major focus on respiratory
           health. Participants will also be asked to provide information on their food
           consumption, physical activity levels and psychological well-being. Subjects should
           return the completed questionnaires at the swimming pool facilities. A medical
           examination will also be performed by trained health professionals and will include
           anthropometric measurements, blood pressure evaluation, urine sample collection, skin
           prick testing, exhaled breath condensate collection, lung function evaluation by
           spirometry with bronchodilation, in a period conveniently scheduled with the
           participating subjects.

           The assessment of swimming pool chemical (DBPs and others), physicochemical and
           microbiological characteristics will include sampling in the water, air and eventually
           selected surfaces, that include: pool edges, stairs and starting blocks, floors (pool
           and bathhouse), walls (concrete and glass of the pool and bathhouse) and highly touched
           surfaces such as bathhouse benches. We will measure different chemical, physicochemical
           and microbiological parameters in multiple locations within the pool structure in order
           to characterize the exposure and its spatial and temporal distribution both within a
           specific swimming pool and also between the different swimming pools studied.

        2. Uncontrolled, before and after study. A single, indoor, 50-meter-long chlorinated
           swimming pool in Porto, Portugal, will be selected for this study. The administrative
           board will be approached by the research team to present the study's purposes and
           procedures and to obtain their consent to perform the study. Upon acceptance, the
           competitive swimming team will be asked to participate in the study. All subjects will
           receive a written description of the study (appendix I-b) and the informed consent form
           (appendix II-b). Competitive swimmers with 12 years of age or older who provide an
           informed consent signed by both the subject and legal tutor (if a minor) will be
           included in an uncontrolled before and after study to assess acute and chronic
           respiratory symptoms after a regular training session. This assessment will be executed
           following two approaches:

             1. Assessment of acute changes: in a period conveniently scheduled with the swimmers
                and their coaches, a medical examination will be performed in order to assess
                baseline respiratory biomarkers of competitive swimmers. This examination will
                include the assessment of exhaled breath condensate and lung function evaluation.
                The same biological measurements will be performed after a single regular training
                session and an interviewer-administered questionnaire will be applied.

             2. Assessment of chronic changes: Competitive swimmers will also be followed through a
                90-day period in order to evaluate long-term changes in respiratory and cancer
                biomarkers. The baseline evaluation will consist in the assessment of biological
                measurements, namely anthropometric measurements, blood pressure evaluation, sample
                collection (i.e. blood and urine samples and buccal swab), skin prick testing,
                pupillometry, capsaicin challenge, exhaled breath condensate collection, lung
                function evaluation (namely, spirometry with bronchodilation, impulse oscillometry,
                methacholine challenge and fractional concentration of orally exhaled nitric oxide)
                and transepidermal water loss assessment. Participants will also be asked to
                provide information on sociodemographic characteristics, personal and family
                history of disease, use of medication, frequency of self-reported respiratory,
                ocular and cutaneous symptoms, data on health-related behaviors, namely tobacco
                use, physical activity levels and food consumption, through an
                interviewer-administered questionnaire. A full examination will be performed only
                at baseline and at the follow-up assessment (90 days after).

      This evaluation will be performed by trained health professionals in a room inside the
      swimming pool facilities but separated from the swimming pool area, in a period conveniently
      scheduled with the swimmers and their coaches. Due to the possibility of experiencing
      transient symptoms, participants will be asked to visit the research department in order to
      perform the methacholine challenge. Participants will be reimbursed for any travel expenses.
observational model: Case-Crossover
time perspective: Cross-Sectional
measure: Spirometry with bronchodilation
time frame: First week after recruitment
measure: Airway resistance measurement
time frame: First week after recruitment
measure: Airway reactance measurement
time frame: First week after recruitment
measure: Fractional concentration of orally exhaled nitric oxide
time frame: First week after recruitment
measure: Volatile organic compounds in the exhaled breath condensate
time frame: First week after recruitment
measure: Diagnosis of immunoglobulin E (IgE) mediated allergies by skin prick testing
time frame: First week after recruitment
measure: Autonomic nervous system function assessment by pupillometry
time frame: First week after recruitment
measure: Transepidermal water loss
time frame: First week after recruitment
arm group label: Competitive swimmers
description: Regular and naïf competitive swimmers will be followed for a mean period of 90 days. A battery of measurements and biological samples will be collected at the baseline evaluation and 90 days after, in order to evaluate long-term changes in respiratory health biomarkers. Measurements will also be performed before and after a single regular training session in order to assess acute effects in respiratory health biomarkers.
arm group label: Recreational swimmers and swimming pool staff
description: Swimming pool physicochemical and microbiological characteristics and the association between each parameter measured as an indicator of water and air quality, contamination of surfaces will be evaluated and the association with recreational users, swimming teachers and pool attendants health parameters will be studied.
Exhaled breath condensate (no DNA) Blood (DNA) Urine (DNA)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
contact: 
contact backup: 
investigator: 
country: Portugal
responsible party type: Sponsor
mesh term: Lung Diseases
sharing ipd: No