The Austrian LEAD (Lung hEart sociAl boDy) Study (LEAD)
|ClinicalTrials.gov Identifier: NCT01727518|
Recruitment Status : Enrolling by invitation
First Posted : November 16, 2012
Last Update Posted : January 20, 2016
|Condition or disease|
|Respiration Disorders Body Composition, Beneficial|
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.
|Study Type :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||The Austrian LEAD (Lung hEart sociAl boDy) Study|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||October 2023|
- The prevalence of COPD in a general population of Austria [ Time Frame: 4 years ]
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.
- Longitudinal study of the natural history of lung function growth and decline (NATHIS) [ Time Frame: 12 years ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727518
|The LEAD Study Center|
|Vienna, Austria, 1140|
|Principal Investigator:||O C Burghuber, Prof.Dr.||Ludwig Boltzmann Institute for COPD and Respiratory Epidemiology|