The Austrian LEAD (Lung hEart sociAl boDy) Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
ClinicalTrials.gov Identifier:
NCT01727518
First received: November 4, 2012
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

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.


Condition
Respiration Disorders
Body Composition, Beneficial
Mental Disorders Due to Known Physiological Conditions

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Austrian LEAD (Lung hEart sociAl boDy) Study

Resource links provided by NLM:


Further study details as provided by LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology:

Primary Outcome Measures:
  • The prevalence of COPD in a general population of Austria [ Time Frame: 4 years ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Longitudinal study of the natural history of lung function growth and decline (NATHIS) [ Time Frame: 12 years ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Samples of urine and blood


Estimated Enrollment: 10000
Study Start Date: October 2011
Estimated Study Completion Date: October 2023
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Reference Population
No Intervention

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Community based cohort

Criteria

Inclusion Criteria:

  • Male and Female,
  • Age 6 - 80 years,
  • Invitation by study invitation letter

Exclusion Criteria:

  • Insufficient language skills
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727518

Locations
Austria
The LEAD Study Center
Vienna, Austria, 1140
Sponsors and Collaborators
LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
Investigators
Principal Investigator: O C Burghuber, Prof.Dr. Ludwig Boltzmann Institute for COPD and Respiratory Epidemiology
  More Information

Additional Information:
No publications provided

Responsible Party: LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
ClinicalTrials.gov Identifier: NCT01727518     History of Changes
Other Study ID Numbers: LEAD1
Study First Received: November 4, 2012
Last Updated: November 15, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology:
natural history
lung function
reference population
COPD

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Respiration Disorders
Schizophrenia and Disorders with Psychotic Features
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014