The Austrian LEAD (Lung hEart sociAl boDy) Study

Respiration Disorders Clinical Trial

— LEAD  

Official title:

The Austrian LEAD (Lung hEart sociAl boDy) Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01727518
• Other study ID #: LEAD1
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 4, 2012
• Last updated: January 16, 2016
• Start date: October 2011
• Est. completion date: October 2023

Study information

• Verified date: January 2016
• Source: LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: October 2023
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male and Female,

• Age 6 - 80 years,

• Invitation by study invitation letter

Exclusion Criteria:

• Insufficient language skills

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Body Composition, Beneficial
• Respiration Disorders

Locations

Country	Name	City	State
Austria	The LEAD Study Center	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of COPD in a general population of Austria	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.	4 years	No
Secondary	Longitudinal study of the natural history of lung function growth and decline (NATHIS)	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.	12 years	No

External Links

•   Homepage of the Austrian LEAD Study for participants, in German only