Trial Outcomes & Findings for The Austrian LEAD (Lung hEart sociAl boDy) Study (NCT NCT01727518)

Results Overview

Prebronchodilation (pre-BD) and post-BD forced spirometry measurements were determined according to international recommendations (ERS Global Lung Function Initiative). Abnromal lung function determined as forced expiratory volume in 1 second (FEV1) \< Lower Limit of Normal (LLN) or forced vital capacity (FVC) \< LLN or FEV1/FVC \< LLN.

Recruitment status

ACTIVE_NOT_RECRUITING

Target enrollment

14966 participants

Primary outcome timeframe

4 years

Results posted on

2024-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	General Population Due to the observational, non interventional design of this study, there is only one Arm/Group (general population). All participants of the study receive the same measurements and quetionnaires and are re-evaluated every 4 years. Measurements include 1. lung function testing (spirometry/bodyplethysmography pre and post BD), 2. body composition testing (DXA Scan), 3. cardiovadcular testing (pulse wave velocity, ecg), 4. Skin Prick Test. For more detailed information please see study profile.
Overall Study STARTED	14966
Overall Study COMPLETED	14966
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Austrian LEAD (Lung hEart sociAl boDy) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reference Population n=14966 Participants No Intervention; obersvation healthy group (no symptoms and no lung function impairment)
Age, Categorical <=18 years	3182 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9652 Participants n=5 Participants
Age, Categorical >=65 years	2132 Participants n=5 Participants
Sex: Female, Male Female	8006 Participants n=5 Participants
Sex: Female, Male Male	6960 Participants n=5 Participants
Region of Enrollment Austria	14966 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 years

Population: General population cohort

Prebronchodilation (pre-BD) and post-BD forced spirometry measurements were determined according to international recommendations (ERS Global Lung Function Initiative). Abnromal lung function determined as forced expiratory volume in 1 second (FEV1) \< Lower Limit of Normal (LLN) or forced vital capacity (FVC) \< LLN or FEV1/FVC \< LLN.

Outcome measures

Outcome measures
Measure	General Population (6-15 Years) n=981 Participants participants at age category of 6-\<15 years	General Population (15-30 Years) n=2012 Participants participants at age category of 15-\<30 years	General Population (30-45 Years) n=2404 Participants participants at age category of 30-\<45 years	General Population (45-60 Years) n=3010 Participants participants at age category of 45-\<60 years	General Population (60-82 Years) n=2972 Participants participants at age category of 60-82 years
Abnormal Lung Function in the General Population percentage of participants with FEV1< lower limit of normal (LLN)	65 Participants	145 Participants	178 Participants	226 Participants	252 Participants
Abnormal Lung Function in the General Population percentage of participants with FVC< lower limit of normal (LLN)	52 Participants	121 Participants	96 Participants	108 Participants	143 Participants
Abnormal Lung Function in the General Population percentage of participants with FEV1/FVC< lower limit of normal (LLN)	44 Participants	133 Participants	211 Participants	259 Participants	235 Participants

Adverse Events

General Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Robab Breyer-Kohansal

Ludwig Boltzmann Institute for Lung Health

Phone: +436505398439

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place