The Austrian LEAD (Lung hEart sociAl boDy) Study (LEAD)

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.

Study Overview

Status

Enrolling by invitation

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.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vienna, Austria, 1140
        • The LEAD Study Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Community based cohort

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Insufficient language skills

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Reference Population
No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: O C Burghuber, Prof.Dr., Ludwig Boltzmann Institute for COPD and Respiratory Epidemiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ANTICIPATED)

May 1, 2016

Study Completion (ANTICIPATED)

October 1, 2023

Study Registration Dates

First Submitted

November 4, 2012

First Submitted That Met QC Criteria

November 15, 2012

First Posted (ESTIMATE)

November 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 16, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEAD1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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