<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/NCT01727518</url>
  </required_header>
  <id_info>
    <org_study_id>LEAD1</org_study_id>
    <nct_id>NCT01727518</nct_id>
  </id_info>
  <brief_title>The Austrian LEAD (Lung hEart sociAl boDy) Study</brief_title>
  <acronym>LEAD</acronym>
  <official_title>The Austrian LEAD (Lung hEart sociAl boDy) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Austrian LEAD study is the first investigation initiated in Austria that aims to&#xD;
      investigate the prevalence and the natural history of COPD in a reference population of&#xD;
      Austria.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) is one of the most important causes of morbidity&#xD;
      and mortality worldwide and has a tremendous impact on the individual patient, the healthcare&#xD;
      system, and the general public.&#xD;
&#xD;
      Contrary to other chronic diseases, the natural history of COPD, commonly described with the&#xD;
      natural decline of lung function, has not been investigated sufficiently and the presence of&#xD;
      various phenotypes is still under intensive investigation.&#xD;
&#xD;
      The investigators aim to study the natural course of lung function and the development of&#xD;
      COPD in a longitudinal, observational, population based cohort in Austria.&#xD;
&#xD;
      Study population (male and female, age 6 - 80 years) will be randomly recruited via the&#xD;
      national inhabitants register in both Vienna (urban cohort) and Lower Austria (rural cohort).&#xD;
&#xD;
      Health examinations will include lung function testing, cardiovascular examinations, body&#xD;
      composition and metabolic testing as well as socioeconomic counseling. Furthermore, the&#xD;
      initiation of a bio bank will provide serological testing on biomarker and epigenetic&#xD;
      analysis.&#xD;
&#xD;
      In particular, the investigators intend to assess a) the age-related natural decline in lung&#xD;
      function in the general population, b) the prevalence of COPD and the development of major&#xD;
      respiratory symptoms in this disease, c) the prevalence of the most important COPD&#xD;
      comorbidities (cardiovascular, metabolic and cognitive dysfunction) and d) the association&#xD;
      between lung health and social status, individual long term exposure to air pollution and&#xD;
      other toxic inhalants.&#xD;
&#xD;
      This health examination will be the first investigation in Austria providing information&#xD;
      about the most prevalent respiratory disease and it's comorbidities in a longitudinal&#xD;
      approach.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The prevalence of COPD in a general population of Austria</measure>
    <time_frame>4 years</time_frame>
    <description>The Burden of Obstructive Lung Disease (BOLD) Study revealed in 2007 a surprisingly high prevalence of COPD in Salzburg (26%) as compared to other European countries (about 10%), particularly in young women aged 40 to 59 years.&#xD;
However, reliable data about the prevalence of COPD in Austria is lacking. Therefore, the aims are 1. To estimate the prevalence of COPD in the general population of Austria, 2. To explore if the prevalence of COPD is different in urban and rural environments and associated to risk factors as smoking, socioeconomic status (income, education, and occupation), diagnosis of asthma, and presence of allergy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Longitudinal study of the natural history of lung function growth and decline (NATHIS)</measure>
    <time_frame>12 years</time_frame>
    <description>Lung growths until the age of 15 in females and in the mid-20s in males and declines over time. Compared to female, lung function decline in male starts after a plateau phase and lung function decline is slightly higher compared to female.However, until now it is unclear if female smokers are more susceptible to the deleterious effects of tobacco smoking than male. Therefore, the aims are: 1.To investigate the natural history of lung function in a &quot;healthy population&quot; (defined by a population free of respiratory symptoms and/or disease, metabolic, cardiovascular and/or mental diseases) and to determine normal lung function growth and decline over time. 2.To investigate the influence of smoking, smoking cessation, air pollution (urban vs. rural), socioeconomic status (income, education, and occupation), allergy, bronchial hyperactivity and systemic inflammation on lung function growth and decline over time. 3.To identify the risk factors for accelerated decline of lung function.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Respiration Disorders</condition>
  <condition>Body Composition, Beneficial</condition>
  <arm_group>
    <arm_group_label>Reference Population</arm_group_label>
    <description>No Intervention</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Samples of urine and blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Community based cohort&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and Female,&#xD;
&#xD;
          -  Age 6 - 80 years,&#xD;
&#xD;
          -  Invitation by study invitation letter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insufficient language skills&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>O C Burghuber, Prof.Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ludwig Boltzmann Institute for COPD and Respiratory Epidemiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The LEAD Study Center</name>
      <address>
        <city>Vienna</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <link>
    <url>http://www.leadstudy.at</url>
    <description>Homepage of the Austrian LEAD Study for participants, in German only</description>
  </link>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>November 4, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>January 16, 2016</last_update_submitted>
  <last_update_submitted_qc>January 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>natural history</keyword>
  <keyword>lung function</keyword>
  <keyword>general population</keyword>
  <keyword>COPD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiration Disorders</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>April 13, 2020</submitted>
    <returned>April 23, 2020</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/NCT01727518
org study id: LEAD1
nct id: NCT01727518
lead sponsor: 
has dmc: No
The Austrian LEAD study is the first investigation initiated in Austria that aims to
      investigate the prevalence and the natural history of COPD in a reference population of
      Austria.
Chronic obstructive pulmonary disease (COPD) is one of the most important causes of morbidity
      and mortality worldwide and has a tremendous impact on the individual patient, the healthcare
      system, and the general public.

      Contrary to other chronic diseases, the natural history of COPD, commonly described with the
      natural decline of lung function, has not been investigated sufficiently and the presence of
      various phenotypes is still under intensive investigation.

      The investigators aim to study the natural course of lung function and the development of
      COPD in a longitudinal, observational, population based cohort in Austria.

      Study population (male and female, age 6 - 80 years) will be randomly recruited via the
      national inhabitants register in both Vienna (urban cohort) and Lower Austria (rural cohort).

      Health examinations will include lung function testing, cardiovascular examinations, body
      composition and metabolic testing as well as socioeconomic counseling. Furthermore, the
      initiation of a bio bank will provide serological testing on biomarker and epigenetic
      analysis.

      In particular, the investigators intend to assess a) the age-related natural decline in lung
      function in the general population, b) the prevalence of COPD and the development of major
      respiratory symptoms in this disease, c) the prevalence of the most important COPD
      comorbidities (cardiovascular, metabolic and cognitive dysfunction) and d) the association
      between lung health and social status, individual long term exposure to air pollution and
      other toxic inhalants.

      This health examination will be the first investigation in Austria providing information
      about the most prevalent respiratory disease and it's comorbidities in a longitudinal
      approach.
observational model: Cohort
time perspective: Prospective
measure: The prevalence of COPD in a general population of Austria
time frame: 4 years
description: The Burden of Obstructive Lung Disease (BOLD) Study revealed in 2007 a surprisingly high prevalence of COPD in Salzburg (26%) as compared to other European countries (about 10%), particularly in young women aged 40 to 59 years.
However, reliable data about the prevalence of COPD in Austria is lacking. Therefore, the aims are 1. To estimate the prevalence of COPD in the general population of Austria, 2. To explore if the prevalence of COPD is different in urban and rural environments and associated to risk factors as smoking, socioeconomic status (income, education, and occupation), diagnosis of asthma, and presence of allergy.
measure: Longitudinal study of the natural history of lung function growth and decline (NATHIS)
time frame: 12 years
description: Lung growths until the age of 15 in females and in the mid-20s in males and declines over time. Compared to female, lung function decline in male starts after a plateau phase and lung function decline is slightly higher compared to female.However, until now it is unclear if female smokers are more susceptible to the deleterious effects of tobacco smoking than male. Therefore, the aims are: 1.To investigate the natural history of lung function in a "healthy population" (defined by a population free of respiratory symptoms and/or disease, metabolic, cardiovascular and/or mental diseases) and to determine normal lung function growth and decline over time. 2.To investigate the influence of smoking, smoking cessation, air pollution (urban vs. rural), socioeconomic status (income, education, and occupation), allergy, bronchial hyperactivity and systemic inflammation on lung function growth and decline over time. 3.To identify the risk factors for accelerated decline of lung function.
arm group label: Reference Population
description: No Intervention
Samples of urine and blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: O C Burghuber, Prof.Dr.
role: Principal Investigator
affiliation: Ludwig Boltzmann Institute for COPD and Respiratory Epidemiology
facility: 
country: Austria
url: http://www.leadstudy.at
description: Homepage of the Austrian LEAD Study for participants, in German only
responsible party type: Sponsor
mesh term: Respiration Disorders
submitted: April 13, 2020
returned: April 23, 2020