American Lung Association (ALA) Lung Health Cohort
- Conditions
- Lung Diseases
- Registration Number
- NCT04543461
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
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.
- Detailed Description
The scientific goal of the study is to establish the relationship between a variety of factors (lifetime environmental exposures, fitness and physical activity, biomarkers, nasal respiratory epithelial transcriptome) and ideal versus impaired peak lung health (reserve and markers of susceptibility in investigators' model) in young adulthood. In addition to the initial baseline assessment, remote contacts (e.g., via text message, email, mail, or phone) at regular intervals will allow for both the retention of the participants as well as the collection of additional short-term follow-up information, i.e., within 4.5 years of enrollment. If additional funding becomes available, investigators will extend the study for an additional period of time to study factors related to long-term changes in lung health over time, i.e., at 5 years and beyond. Recruitment of participants will be conducted by the participating study sites along with national and regional efforts from the American Lung Association. Recruitment efforts will be supported by the study web site www.lung.org/lung-study
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4000
1- Age 25-35 years at the time of the baseline examination 2- Able to read and understand English or Spanish 3 -Has a social security number 4- Resident (citizen or non-citizen) of the United States (US) for at least 12 months prior to examination. Note: Individuals who are residents of the US who have temporarily spent time living outside of the US during the last 12 months (e.g., student exchange program, military posting) are eligible for participation.
5- Willing to provide contact information for at least 2 proxies who are likely to know the whereabouts and vital status of the participant
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Severe asthma, which is defined as any of the following:
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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.
OR
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3 or more unscheduled healthcare visits (provider/urgent care/ER) for asthma in the past 12 months OR
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One asthma hospitalization in the past 12 months
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History of any chronic lung disease other than asthma including but not limited to COPD, cystic fibrosis, pulmonary fibrosis, pulmonary hypertension
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Current pregnancy
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History of cancer other than non-melanoma skin cancer
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Diagnosed cardiovascular diseases (i.e., congenital heart disease, coronary heart disease)
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Inability to comply with study procedures, including
- Inability or unwillingness to provide informed consent
- Inability to perform study measurements
- Inability to be contacted by phone (via calls and/or text messaging) or email
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Any condition in the opinion of the physician that puts the participant at risk by participating in the study (e.g., serious respiratory illness requiring antibiotics or steroids or severe fever at the time of the study visit).
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Institutionalization
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pre-bronchodilator measurements of Forced Vital Capacity (FVC) Baseline 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
Pre-bronchodilator measurement of Forced Expiratory Volume in one second (FEV1) Baseline 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
University Of Alabama
🇺🇸Birmingham, Alabama, United States
University of Arizona-Tuscon
🇺🇸Tucson, Arizona, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Nemours Children's Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Florida, Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Rush Universtiy
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
St. Vincent's Health System
🇺🇸Indianapolis, Indiana, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Kansas
🇺🇸Kansas City, Kansas, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Brigham and Women's
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Presbyterian Brooklyn Methodist Hospital
🇺🇸Brooklyn, New York, United States
New York Medical College
🇺🇸Hawthorne, New York, United States
New York University
🇺🇸New York, New York, United States
Mt. Sinai, NYC
🇺🇸New York, New York, United States
Columbia University
🇺🇸New York, New York, United States
Cornell University
🇺🇸New York, New York, United States
University of Rochester
🇺🇸Rochester, New York, United States
University of North Carolina Hospital
🇺🇸Chapel Hill, North Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States
Wake Forest School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburg-Emphysema/COPD Research Center
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Vermont
🇺🇸Colchester, Vermont, United States
University of Washington
🇺🇸Seattle, Washington, United States
University of Wisconsin Madison
🇺🇸Madison, Wisconsin, United States