<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/NCT03823586</url>
  </required_header>
  <id_info>
    <org_study_id>01/2019</org_study_id>
    <nct_id>NCT03823586</nct_id>
  </id_info>
  <brief_title>AQUApay (AQUA Predictive Ability in Youths): Study on the Predictive Ability of the Questionnaire AQUA© in Children and Adolescents</brief_title>
  <official_title>AQUApay (AQUA Predictive Ability in Youths): Study on the Predictive Ability of the Questionnaire AQUA© in Children and Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto per la Ricerca e l'Innovazione Biomedica</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto per la Ricerca e l'Innovazione Biomedica</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>
      Allergic diseases like asthma, rhinitis, conjunctivitis and dermatitis are very frequent in&#xD;
      athletes, even if those complaining allergic symptoms do not always receive a medical&#xD;
      diagnosis. Many athletes already start competitive sport activities in pediatric age, but&#xD;
      allergy screening tests are usually not performed when assessing eligibility to sport&#xD;
      practice. Therefore, the objective of the present study is assessing the predictive ability&#xD;
      of the Allergy Questionnaire for Athletes (AQUA©), pediatric version, to predict the atopic&#xD;
      status in young athletes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 11, 2019</start_date>
  <completion_date type="Actual">February 7, 2020</completion_date>
  <primary_completion_date type="Actual">February 7, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Atopic status</measure>
    <time_frame>Day 0</time_frame>
    <description>Having at least 1 positive skin prick test to common aero-allergens</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychological well-being</measure>
    <time_frame>Day 0</time_frame>
    <description>Percentage score from the WHO-5 questionnaire for measuring psychological well-being.&#xD;
The questionnaire is composed of 5 questions scored on a scale ranging from 0 (worse outcome) to 5 (best outcome). The total (raw) score is obtaining by summing all the individual score items, therefore it ranges from 0 (worse outcome) to 25 (best outcome). To obtain a percentage score ranging from 0 to 100, the raw score is multiplied by 4. A percentage score of 0 represents worst possible outcome, whereas a score of 100 represents best possible outcome.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">133</enrollment>
  <condition>Young Athletes</condition>
  <arm_group>
    <arm_group_label>Children</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Adolescents</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Questionnaire AQUA©, pediatric version</intervention_name>
    <description>A version of AQUA© recently adapted and pretested in young athletes. It is a self-administered questionnaire composed of 25 items includes items about type, duration and intensity of training sessions, allergic status, habits of children (supplements and drugs intake) and their parents (smoking), presence and burden of infections.</description>
    <arm_group_label>Adolescents</arm_group_label>
    <arm_group_label>Children</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Athletes aged 7 to 14 years old, recruited from several sport associations located in the&#xD;
        city of Palermo (Italy).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Athletes, males or females, 7 to 14 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of systemic antihistamines or long term or high dose corticosteroids in the last&#xD;
             two weeks;&#xD;
&#xD;
          -  Poor understanding of written or spoken Italian;&#xD;
&#xD;
          -  Lack of written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council</name>
      <address>
        <city>Palermo</city>
        <state>Sicily</state>
        <zip>90146</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituto per la Ricerca e l'Innovazione Biomedica</investigator_affiliation>
    <investigator_full_name>Stefania La Grutta, MD</investigator_full_name>
    <investigator_title>Coordinator of the group &quot;Clinical and Environmental Epidemiology of Pulmonary and Allergic Pediatric Diseases&quot;. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.</investigator_title>
  </responsible_party>
  <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/NCT03823586
org study id: 01/2019
nct id: NCT03823586
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Allergic diseases like asthma, rhinitis, conjunctivitis and dermatitis are very frequent in
      athletes, even if those complaining allergic symptoms do not always receive a medical
      diagnosis. Many athletes already start competitive sport activities in pediatric age, but
      allergy screening tests are usually not performed when assessing eligibility to sport
      practice. Therefore, the objective of the present study is assessing the predictive ability
      of the Allergy Questionnaire for Athletes (AQUA©), pediatric version, to predict the atopic
      status in young athletes.
observational model: Other
time perspective: Cross-Sectional
measure: Atopic status
time frame: Day 0
description: Having at least 1 positive skin prick test to common aero-allergens
measure: Psychological well-being
time frame: Day 0
description: Percentage score from the WHO-5 questionnaire for measuring psychological well-being.
The questionnaire is composed of 5 questions scored on a scale ranging from 0 (worse outcome) to 5 (best outcome). The total (raw) score is obtaining by summing all the individual score items, therefore it ranges from 0 (worse outcome) to 25 (best outcome). To obtain a percentage score ranging from 0 to 100, the raw score is multiplied by 4. A percentage score of 0 represents worst possible outcome, whereas a score of 100 represents best possible outcome.
arm group label: Children
arm group label: Adolescents
intervention type: Diagnostic Test
intervention name: Questionnaire AQUA©, pediatric version
description: A version of AQUA© recently adapted and pretested in young athletes. It is a self-administered questionnaire composed of 25 items includes items about type, duration and intensity of training sessions, allergic status, habits of children (supplements and drugs intake) and their parents (smoking), presence and burden of infections.
arm group label: Adolescents
arm group label: Children
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Istituto per la Ricerca e l'Innovazione Biomedica
investigator full name: Stefania La Grutta, MD
investigator title: Coordinator of the group "Clinical and Environmental Epidemiology of Pulmonary and Allergic Pediatric Diseases". Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.
sharing ipd: No