About this trial
The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately 4,000 young adults between the ages of 25-35 who do not have severe lung disease. The overarching objective of the ALA-LHC is to establish a national cohort of young adults for the purpose of defining lung health and developing targets to intercept chronic lung disease at its earliest stages.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Current (i.e. at the time of the visit) GINA Step 4 or higher therapy (medium dose ICS/LABA or high dose ICS or add-on LAMA; Medium dose = >250 fluticasone, propionate =100 fluticasone furoate, >200 beclomethasone, >400 budesonide, >220 mometasone). We will accept low-dose ICS/LABA or medium dose ICS.
3 or more unscheduled healthcare visits (provider/urgent care/ER) for asthma in the past 12 months OR
One asthma hospitalization in the past 12 months
History of any chronic lung disease other than asthma including but not limited to COPD, cystic fibrosis, pulmonary fibrosis, pulmonary hypertension
Trial population
Young adults between 25 and 35 year of age at baseline
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Pre-bronchodilator measurement of Forced Expiratory Volume in one second (FEV1)
Pre-bronchodilator measurements of FEV1 to determine bronchoconstriction. FEV1 is measured in liters of air. Severity of bronchoconstriction is based on predicted values published by National Health and Nutrition Examination Survey (NHANES III hankinson) for height, weight and age. Predicted values are reported as percent predicted with a result of 80% or greater considered normal
Pre-bronchodilator measurements of Forced Vital Capacity (FVC)
Pre-bronchodilator measurements FVC to determine lung volume. FVC is measured in liters of air. Participants predicted vital lung capacity is based on values published by National Health and Nutrition Examination Survey (NHANES III hankinson) for height, weight and age. Predicted values are reported as percent predicted with a result of 80% or greater considered normal
Sponsors and contacts
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Johns Hopkins University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
American Lung Association
Collaborator
Stanford University
Collaborator