<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/NCT03038698</url>
  </required_header>
  <id_info>
    <org_study_id>BE295/16</org_study_id>
    <nct_id>NCT03038698</nct_id>
  </id_info>
  <brief_title>Paediatric and Adult African Spirometry II</brief_title>
  <acronym>PAASII</acronym>
  <official_title>Paediatric and Adult African Spirometry II: A Determination of Reference Equation in South African Children and Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of KwaZulu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical Research Council, South Africa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of KwaZulu</source>
  <oversight_info>
    <has_dmc>No</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>
      Pulmonary function testing is the most widely used tool for the diagnosis, severity&#xD;
      assessment, management, risk factor categorization and follow-up of individuals with chronic&#xD;
      lung disease. Africa has a high burden of infectious respiratory diseases which include&#xD;
      tuberculosis, asthma and human immunodeficiency virus-related lung disease. Coupled with this&#xD;
      is an increasing burden of non-communicable respiratory diseases; which include chronic&#xD;
      obstructive pulmonary disease, emphysema, bronchiectasis and asthma. A proviso to the use of&#xD;
      lung function testing is the determination of &quot;normal&quot; values; which are determined for age,&#xD;
      gender, height and ethnicity for the relevant population. It is well recognised that the&#xD;
      comparison of an individual patients' results to an ethnically inappropriate population may&#xD;
      lead to the under or -over diagnosis of disease, inappropriate treatments and result in&#xD;
      increased burden on individuals, their families and the healthcare system.&#xD;
&#xD;
      The investigators therefore propose to conduct a prospective well-designed study to include a&#xD;
      representative sample of both adults and children (4000); to verify the validity of the&#xD;
      retrospective pilot data, in a South African population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pulmonary function testing is the most widely used tool for the diagnosis, severity&#xD;
      assessment, management, risk factor categorization and follow-up of individuals with chronic&#xD;
      lung disease. Africa has a high burden of infectious respiratory diseases which include&#xD;
      tuberculosis and human immunodeficiency virus-related lung disease.Coupled with this is an&#xD;
      increasing burden of non-communicable respiratory diseases; which include chronic obstructive&#xD;
      pulmonary disease, emphysema, bronchiectasis and asthma [1,2]. The management of these&#xD;
      colliding epidemics requires correct diagnosis and management in order to ensure adequate&#xD;
      resource allocation and avoidance of unnecessary costs.&#xD;
&#xD;
      A proviso to the use of lung function testing is the determination of &quot;normal&quot; values; which&#xD;
      are determined for age, gender, height and ethnicity for the relevant population [3]. These&#xD;
      &quot;normal' values should also take into account the normal lung function decline associated and&#xD;
      the aging process. It is well recognised that the comparison of an individual patients'&#xD;
      results to an ethnically inappropriate population may lead to the under or -over diagnosis of&#xD;
      disease, inappropriate treatments and result in increased burden on individuals, their&#xD;
      families and the healthcare system [4-6]. There are numerous published reference equations,&#xD;
      but the recently published Global Lung Initiative multi-ethnic reference equations published&#xD;
      in 2012(GLI2012) collated the largest spirometry data set from individuals aged 2.5 to 95&#xD;
      years [7]. The innovation in GLI2012 was that it allowed for the smooth transitioning of data&#xD;
      from childhood adulthood using sophisticated statistical modelling.&#xD;
&#xD;
      The investigators have previously collated data in phase 1 of this study using the GLI&#xD;
      methodology on published African spirometry data from 26 594 individuals, and found a wide&#xD;
      variation in predicted z-scores when fitting the African data to GLI2012, with a fairly good&#xD;
      match between the black African males and African-Americans [15]. This dataset was skewed as&#xD;
      due to the large number of African males and with a disproportionally larger contribution of&#xD;
      data from North Africa and therefore requires confirmation. The investigators therefore&#xD;
      propose to conduct a prospective well-designed study to include a representative sample of&#xD;
      both adults and children (4000); to verify the validity of the retrospective pilot data, in a&#xD;
      South African population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>lung function in healthy adults and children</measure>
    <time_frame>2 years</time_frame>
    <description>lung function reference equations determination in healthy adults and children</description>
  </primary_outcome>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Lung Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This study will be conducted in four regions in South Africa: KwaZulu Natal, Western Cape,&#xD;
        Limpopo and Gauteng Province. Two sampling frames will be used with a paediatric and adult&#xD;
        population. The paediatric sample frame will be school-going children (6 to 18 years) at&#xD;
        primary and secondary schools during school days. For the adult sample, data will be&#xD;
        collected on healthy adults age of 18 to 95 years, lung function testing will be conducted&#xD;
        in conjunction with the South African Statistical Services (General Health Survey) a&#xD;
        household surveys to ensure random population sampling from the four identified provinces&#xD;
        from January 2016 to October 2017.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Study involves African adults and children age 5 to 95 years.&#xD;
&#xD;
          -  Study number of at least 300 'healthy' subjects [7] per population band as per table&#xD;
             1.&#xD;
&#xD;
          -  Availability of essential background information for each subject (birth date, date of&#xD;
             test, gender, height, weight, body mass index, socioeconomic status and ethnic group).&#xD;
&#xD;
          -  Consent given for adults 18 years and above, and assent for children over the age of 8&#xD;
             years and parental/guardian consent for all children under the age of 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inter-current upper or lower respiratory tract infection&#xD;
&#xD;
          -  Chronic lung diseases: including asthma and chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Current or previous tuberculosis infection&#xD;
&#xD;
          -  Myocardial infarction&#xD;
&#xD;
          -  Stroke&#xD;
&#xD;
          -  Muscular disorders&#xD;
&#xD;
          -  Previous history of cardiac diseases&#xD;
&#xD;
          -  Current smoker&#xD;
&#xD;
          -  Past smoker with &gt;5 pack year of tobacco&#xD;
&#xD;
          -  Previous lung surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of KwaZulu Natal</name>
      <address>
        <city>Durban</city>
        <state>KwaZulu Natal</state>
        <zip>4013</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Refiloe Masekela, PhD</last_name>
      <phone>+27312604399</phone>
      <email>masekelar@ukzn.ac.za</email>
    </contact>
    <contact_backup>
      <last_name>Diane Pillay</last_name>
      <phone>+27312604345</phone>
      <email>pillayd31@ukzn.ac.za</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>November 16, 2017</last_update_submitted>
  <last_update_submitted_qc>November 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>spirometry</keyword>
  <keyword>normative values</keyword>
  <keyword>health</keyword>
  <keyword>south africa</keyword>
  <keyword>children</keyword>
  <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>
    <ipd_description>All results of the study will be published in a peer-reviewed journal</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>October 12, 2021</submitted>
    <returned>November 10, 2021</returned>
  </pending_results>
  <!-- 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/NCT03038698
org study id: BE295/16
nct id: NCT03038698
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pulmonary function testing is the most widely used tool for the diagnosis, severity
      assessment, management, risk factor categorization and follow-up of individuals with chronic
      lung disease. Africa has a high burden of infectious respiratory diseases which include
      tuberculosis, asthma and human immunodeficiency virus-related lung disease. Coupled with this
      is an increasing burden of non-communicable respiratory diseases; which include chronic
      obstructive pulmonary disease, emphysema, bronchiectasis and asthma. A proviso to the use of
      lung function testing is the determination of "normal" values; which are determined for age,
      gender, height and ethnicity for the relevant population. It is well recognised that the
      comparison of an individual patients' results to an ethnically inappropriate population may
      lead to the under or -over diagnosis of disease, inappropriate treatments and result in
      increased burden on individuals, their families and the healthcare system.

      The investigators therefore propose to conduct a prospective well-designed study to include a
      representative sample of both adults and children (4000); to verify the validity of the
      retrospective pilot data, in a South African population.
Pulmonary function testing is the most widely used tool for the diagnosis, severity
      assessment, management, risk factor categorization and follow-up of individuals with chronic
      lung disease. Africa has a high burden of infectious respiratory diseases which include
      tuberculosis and human immunodeficiency virus-related lung disease.Coupled with this is an
      increasing burden of non-communicable respiratory diseases; which include chronic obstructive
      pulmonary disease, emphysema, bronchiectasis and asthma [1,2]. The management of these
      colliding epidemics requires correct diagnosis and management in order to ensure adequate
      resource allocation and avoidance of unnecessary costs.

      A proviso to the use of lung function testing is the determination of "normal" values; which
      are determined for age, gender, height and ethnicity for the relevant population [3]. These
      "normal' values should also take into account the normal lung function decline associated and
      the aging process. It is well recognised that the comparison of an individual patients'
      results to an ethnically inappropriate population may lead to the under or -over diagnosis of
      disease, inappropriate treatments and result in increased burden on individuals, their
      families and the healthcare system [4-6]. There are numerous published reference equations,
      but the recently published Global Lung Initiative multi-ethnic reference equations published
      in 2012(GLI2012) collated the largest spirometry data set from individuals aged 2.5 to 95
      years [7]. The innovation in GLI2012 was that it allowed for the smooth transitioning of data
      from childhood adulthood using sophisticated statistical modelling.

      The investigators have previously collated data in phase 1 of this study using the GLI
      methodology on published African spirometry data from 26 594 individuals, and found a wide
      variation in predicted z-scores when fitting the African data to GLI2012, with a fairly good
      match between the black African males and African-Americans [15]. This dataset was skewed as
      due to the large number of African males and with a disproportionally larger contribution of
      data from North Africa and therefore requires confirmation. The investigators therefore
      propose to conduct a prospective well-designed study to include a representative sample of
      both adults and children (4000); to verify the validity of the retrospective pilot data, in a
      South African population.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: lung function in healthy adults and children
time frame: 2 years
description: lung function reference equations determination in healthy adults and children
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 95 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
country: South Africa
responsible party type: Sponsor
mesh term: Lung Diseases
sharing ipd: No
ipd description: All results of the study will be published in a peer-reviewed journal
submitted: October 12, 2021
returned: November 10, 2021