<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/NCT03290222</url>
  </required_header>
  <id_info>
    <org_study_id>ESR-16-12088</org_study_id>
    <nct_id>NCT03290222</nct_id>
  </id_info>
  <brief_title>TRACK: Validation of the Portuguese Version</brief_title>
  <acronym>TRACK</acronym>
  <official_title>Translation, Adaptation Into Portuguese (Brazilian Culture) and Validation of the Test for Respiratory and Asthma Control in Kids (TRACK)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of São Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The TRACK (&quot;Test for Respiratory and Asthma Control in Kids&quot;) questionnaire is a validated&#xD;
      instrument to evaluate the control of respiratory symptoms in young children. The TRACK&#xD;
      questionnaire was developed in English and a version in Portuguese is not available or&#xD;
      validated, purpose of the present project.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The TRACK (&quot;Test for Respiratory and Asthma Control in Kids&quot;) questionnaire is the only&#xD;
      instrument developed and validated so far to evaluate the control of respiratory symptoms in&#xD;
      young children under five years of age. The TRACK questionnaire consists of five questions,&#xD;
      scored from 0 to 20, given to caregivers of children with asthma or recurrent respiratory&#xD;
      symptoms, and addresses respiratory symptoms, nocturnal awakenings and limitation of daily&#xD;
      activities in the last four weeks, use of bronchodilator medications over the past three&#xD;
      months and systemic corticosteroids in the last year.&#xD;
&#xD;
      The TRACK questionnaire was developed in English and has already been translated and&#xD;
      validated into Spanish and Arabic. At the moment there is no translation and validation of&#xD;
      the TRACK questionnaire for the Portuguese language, purpose of the present project.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2017</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Global Initiative for Asthma (GINA) criteria</measure>
    <time_frame>4 weeks</time_frame>
    <description>The TRACK criterion validation will be performed by the comparison of the scores obtained from patients in the three levels of control, according to GINA criteria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory symptoms</measure>
    <time_frame>4 weeks</time_frame>
    <description>Constructive validation will be done by comparing the TRACK notes between patients discriminated according to their respiratory symptoms (symptomatic, recent symptoms, and asymptomatic)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medical opinion</measure>
    <time_frame>4 weeks</time_frame>
    <description>Constructive validation will also be done by comparing the TRACK notes between patients discriminated according to the medical opinion</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">299</enrollment>
  <condition>Asthma</condition>
  <condition>Respiratory Disease</condition>
  <arm_group>
    <arm_group_label>TRACK</arm_group_label>
    <description>Children will be followed for four weeks (3 to 5 weeks) after the inclusion in the study. Parents will complete the TRACK questionnaire in both visit and will answer additional questions about respiratory symptoms and use of medication.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TRACK questionnaire</intervention_name>
    <description>TRACK questionnaire consists of five questions, scored 0-20, to be made to caregivers of children with asthma or recurrent respiratory symptoms, regarding respiratory symptoms, nocturnal awakenings and limitation of daily activities in the last four weeks, use of bronchodilators in the last three months and systemic corticosteroids in the last year</description>
    <arm_group_label>TRACK</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children up to five years of age with recurrent respiratory symptoms attended at pediatric&#xD;
        clinics will be included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Native Portuguese speakers families&#xD;
&#xD;
          -  Medical diagnosis of asthma or history of at least three episodes of cough and/or&#xD;
             wheeze and/or dyspnea (duration longer than 24 hours) and treated with bronchodilators&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other relevant pulmonary diseases (i.e.: cystic fibrosis, bronchopulmonary dysplasia)&#xD;
&#xD;
          -  Systemic diseases (i.e.: heart diseases, neurologic disorders)&#xD;
&#xD;
          -  Premature birth (under 37 weeks of gestational age)&#xD;
&#xD;
          -  Congenital malformations&#xD;
&#xD;
          -  Illiteracy and/or inability of parents to understand the questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Division of Allergy and Clinical Immunology</name>
      <address>
        <city>São Paulo</city>
        <zip>0425002</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Murphy KR, Zeiger RS, Kosinski M, Chipps B, Mellon M, Schatz M, Lampl K, Hanlon JT, Ramachandran S. Test for respiratory and asthma control in kids (TRACK): a caregiver-completed questionnaire for preschool-aged children. J Allergy Clin Immunol. 2009 Apr;123(4):833-9.e9. doi: 10.1016/j.jaci.2009.01.058.</citation>
    <PMID>19348922</PMID>
  </reference>
  <reference>
    <citation>Zeiger RS, Mellon M, Chipps B, Murphy KR, Schatz M, Kosinski M, Lampl K, Ramachandran S. Test for Respiratory and Asthma Control in Kids (TRACK): clinically meaningful changes in score. J Allergy Clin Immunol. 2011 Nov;128(5):983-8. doi: 10.1016/j.jaci.2011.08.010. Epub 2011 Sep 8. Erratum In: J Allergy Clin Immunol. 2012 Jan;129(1):270.</citation>
    <PMID>21906790</PMID>
  </reference>
  <reference>
    <citation>Rodriguez-Martinez CE, Nino G, Castro-Rodriguez JA. Validation of the Spanish version of the Test for Respiratory and Asthma Control in Kids (TRACK) in a population of Hispanic preschoolers. J Allergy Clin Immunol Pract. 2014 May-Jun;2(3):326-31.e3. doi: 10.1016/j.jaip.2014.01.014. Epub 2014 Mar 29.</citation>
    <PMID>24811025</PMID>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>July 31, 2018</last_update_submitted>
  <last_update_submitted_qc>July 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Gustavo Wandalsen</investigator_full_name>
    <investigator_title>Professor of the Pediatrics Department</investigator_title>
  </responsible_party>
  <keyword>Respiratory symptoms</keyword>
  <keyword>Children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03290222
org study id: ESR-16-12088
nct id: NCT03290222
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The TRACK ("Test for Respiratory and Asthma Control in Kids") questionnaire is a validated
      instrument to evaluate the control of respiratory symptoms in young children. The TRACK
      questionnaire was developed in English and a version in Portuguese is not available or
      validated, purpose of the present project.
The TRACK ("Test for Respiratory and Asthma Control in Kids") questionnaire is the only
      instrument developed and validated so far to evaluate the control of respiratory symptoms in
      young children under five years of age. The TRACK questionnaire consists of five questions,
      scored from 0 to 20, given to caregivers of children with asthma or recurrent respiratory
      symptoms, and addresses respiratory symptoms, nocturnal awakenings and limitation of daily
      activities in the last four weeks, use of bronchodilator medications over the past three
      months and systemic corticosteroids in the last year.

      The TRACK questionnaire was developed in English and has already been translated and
      validated into Spanish and Arabic. At the moment there is no translation and validation of
      the TRACK questionnaire for the Portuguese language, purpose of the present project.
observational model: Case-Only
time perspective: Prospective
measure: Global Initiative for Asthma (GINA) criteria
time frame: 4 weeks
description: The TRACK criterion validation will be performed by the comparison of the scores obtained from patients in the three levels of control, according to GINA criteria
measure: Respiratory symptoms
time frame: 4 weeks
description: Constructive validation will be done by comparing the TRACK notes between patients discriminated according to their respiratory symptoms (symptomatic, recent symptoms, and asymptomatic)
measure: Medical opinion
time frame: 4 weeks
description: Constructive validation will also be done by comparing the TRACK notes between patients discriminated according to the medical opinion
arm group label: TRACK
description: Children will be followed for four weeks (3 to 5 weeks) after the inclusion in the study. Parents will complete the TRACK questionnaire in both visit and will answer additional questions about respiratory symptoms and use of medication.
intervention type: Other
intervention name: TRACK questionnaire
description: TRACK questionnaire consists of five questions, scored 0-20, to be made to caregivers of children with asthma or recurrent respiratory symptoms, regarding respiratory symptoms, nocturnal awakenings and limitation of daily activities in the last four weeks, use of bronchodilators in the last three months and systemic corticosteroids in the last year
arm group label: TRACK
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 5 Years
healthy volunteers: No
facility: 
country: Brazil
citation: Murphy KR, Zeiger RS, Kosinski M, Chipps B, Mellon M, Schatz M, Lampl K, Hanlon JT, Ramachandran S. Test for respiratory and asthma control in kids (TRACK): a caregiver-completed questionnaire for preschool-aged children. J Allergy Clin Immunol. 2009 Apr;123(4):833-9.e9. doi: 10.1016/j.jaci.2009.01.058.
PMID: 19348922
citation: Zeiger RS, Mellon M, Chipps B, Murphy KR, Schatz M, Kosinski M, Lampl K, Ramachandran S. Test for Respiratory and Asthma Control in Kids (TRACK): clinically meaningful changes in score. J Allergy Clin Immunol. 2011 Nov;128(5):983-8. doi: 10.1016/j.jaci.2011.08.010. Epub 2011 Sep 8. Erratum In: J Allergy Clin Immunol. 2012 Jan;129(1):270.
PMID: 21906790
citation: Rodriguez-Martinez CE, Nino G, Castro-Rodriguez JA. Validation of the Spanish version of the Test for Respiratory and Asthma Control in Kids (TRACK) in a population of Hispanic preschoolers. J Allergy Clin Immunol Pract. 2014 May-Jun;2(3):326-31.e3. doi: 10.1016/j.jaip.2014.01.014. Epub 2014 Mar 29.
PMID: 24811025
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Gustavo Wandalsen
investigator title: Professor of the Pediatrics Department
mesh term: Asthma
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
sharing ipd: Undecided