American Lung Association (ALA) Lung Health Cohort

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04543461
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH), American Lung Association (Other), Stanford University (Other)
4,000
37
30.1
108.1
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    4000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The American Lung Association (ALA) Lung Health Cohort
    Actual Study Start Date :
    Oct 29, 2021
    Anticipated Primary Completion Date :
    May 1, 2024
    Anticipated Study Completion Date :
    May 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    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

    Exclusion Criteria:
    1. Severe asthma, which is defined as any of the following:

    2. 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

    1. 3 or more unscheduled healthcare visits (provider/urgent care/ER) for asthma in the past 12 months OR

    2. One asthma hospitalization in the past 12 months

    3. History of any chronic lung disease other than asthma including but not limited to COPD, cystic fibrosis, pulmonary fibrosis, pulmonary hypertension

    4. Current pregnancy

    5. History of cancer other than non-melanoma skin cancer

    6. Diagnosed cardiovascular diseases (i.e., congenital heart disease, coronary heart disease)

    7. Inability to comply with study procedures, including

    8. Inability or unwillingness to provide informed consent

    9. Inability to perform study measurements

    10. Inability to be contacted by phone (via calls and/or text messaging) or email

    11. 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).

    12. Institutionalization

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Of Alabama Birmingham Alabama United States 35294
    2 University of Arizona-Tuscon Tucson Arizona United States 85724
    3 University of California, Los Angeles Los Angeles California United States 90095
    4 University of California, San Francisco San Francisco California United States 94143
    5 University of Colorado Aurora Colorado United States 80045
    6 National Jewish Health Denver Colorado United States 80206
    7 Nemours Children's Jacksonville Jacksonville Florida United States 32207
    8 University of Florida, Jacksonville Jacksonville Florida United States 32209
    9 University of Illinois at Chicago Chicago Illinois United States 60608
    10 Northwestern University Chicago Illinois United States 60611
    11 Rush Universtiy Chicago Illinois United States 60612
    12 University of Chicago Chicago Illinois United States 60637
    13 St. Vincent's Health System Indianapolis Indiana United States 46260
    14 University of Iowa Iowa City Iowa United States 52242
    15 University of Kansas Kansas City Kansas United States 66103
    16 Johns Hopkins University Baltimore Maryland United States 21218
    17 Brigham and Women's Boston Massachusetts United States 02115
    18 University of Michigan Ann Arbor Michigan United States 48109
    19 Presbyterian Brooklyn Methodist Hospital Brooklyn New York United States 11215
    20 New York Medical College Hawthorne New York United States 10532
    21 New York University New York New York United States 10016
    22 Mt. Sinai, NYC New York New York United States 10029
    23 Columbia University New York New York United States 10032
    24 Cornell University New York New York United States 10032
    25 University of Rochester Rochester New York United States 14642
    26 University of North Carolina Hospital Chapel Hill North Carolina United States 27517
    27 Duke University Durham North Carolina United States 27710
    28 Wake Forest School of Medicine Winston-Salem North Carolina United States 27104
    29 Ohio State University Columbus Ohio United States 43210
    30 Temple University Philadelphia Pennsylvania United States 19140
    31 University of Pittsburg-Emphysema/COPD Research Center Pittsburgh Pennsylvania United States 15213
    32 Medical University of South Carolina Charleston South Carolina United States 29425
    33 Vanderbilt University Medical Center Nashville Tennessee United States 37235
    34 Baylor College of Medicine Houston Texas United States 77030
    35 University of Vermont Colchester Vermont United States 05446
    36 University of Washington Seattle Washington United States 98108
    37 University of Wisconsin Madison Madison Wisconsin United States 53792

    Sponsors and Collaborators

    • Johns Hopkins University
    • National Heart, Lung, and Blood Institute (NHLBI)
    • American Lung Association
    • Stanford University

    Investigators

    • Principal Investigator: Ravi Kalhan, MD, Northwestern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT04543461
    Other Study ID Numbers:
    • IRB00236497
    • U01HL146408
    First Posted:
    Sep 10, 2020
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Johns Hopkins University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 28, 2022