Deep Functional Phenotyping of the ALA Lung Health Cohort

Last updated: February 19, 2025
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06177717
IRB00273188
U01HL146408-01
  • Ages 25-35
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this observational study is to learn about lung structure and function in a group of 1000 healthy people aged 25 to 35. The main questions it aims to answer are whether people's bodies, environment, and general lung health are associated with:

  • the structure of the participants lungs' airways,

  • the structure of blood vessels in the participants lungs and heart, and

  • the participants lungs' ability to exchange gases.

Participants will take four different lung function tests to measure lung function, including:

  • air movement in the lungs (oscillometry)

  • lung size (slow vital capacity (SVC) and functional residual capacity (FRC)

  • gas transfer in the lungs (diffusing capacity for carbon monoxide (DLCO).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 25-35 years at the time of the baseline examination

  • Able to read and understand English or Spanish

  • Has a social security number

  • Resident (citizen or non-citizen) of the United States (US) for at least 12 monthsprior 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.

  • Willing to provide contact information for at least 2 proxies who are likely to knowthe whereabouts and vital status of the participant

Exclusion

Exclusion Criteria:

  1. Severe asthma, which is defined as any of the following:
  • Current (i.e. at the time of the visit) Global Initiative for Asthma (GINA)Step 4 or higher therapy (medium dose inhaled corticosteroid/long-acting betaagonist (ICS/LABA) or high dose inhaled corticosteroid [ICS] or add-onlong-acting muscarinic antagonist (LAMA); Medium dose = >250 fluticasone,propionate =100 fluticasone furoate, >200 beclomethasone, >400 budesonide, >220mometasone). The investigators will accept low-dose ICS/LABA or medium doseICS. OR

  • 3 or more unscheduled healthcare visits (provider/urgent care/ER) for asthma inthe past 12 months OR

  • One asthma hospitalization in the past 12 months

  1. History of any chronic lung disease other than asthma including but not limited tochronic obstructive pulmonary disease (COPD), cystic fibrosis, pulmonary fibrosis,pulmonary hypertension

  2. Current pregnancy

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

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

  5. 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

  1. Any condition in the opinion of the physician that puts the participant at risk byparticipating in the study (e.g., serious respiratory illness requiring antibioticsor steroids or severe fever at the time of the study visit).

  2. Institutionalization

Study Design

Total Participants: 1000
Study Start date:
February 12, 2024
Estimated Completion Date:
July 30, 2026

Study Description

The parent Lung Health Cohort (LHC) study will leverage the national infrastructure of the American Lung Association's (ALA) Airways Clinical Research Centers (ACRC) to form the first national cohort of adults focused on respiratory health. The parent LHC study will recruit approximately 4000 community-dwelling adults aged 25-35 from metropolitan regions across the U.S. for the purpose of defining lung health and developing targets to intercept chronic lung disease at its earliest stages.

The parent LHC study will be examining a multitude of known and potential factors related to reduced reserve and increased susceptibility to lung disease, such as childhood and adult health status, infections and exposures. Two of the primary outcomes being assessed during this cross-sectional phase of the parent LHC will be spirometry, measured in forced expiratory volume in 1 second (FEV1), respiratory symptoms in relation to environmental exposures, measured in exposure to particulate matter under 2.5 microns in size (PM2.5). These will be assessed in relation to computed tomography (CT) measures of lung injury. The ancillary study expands the phenotyping to include detailed measurements of lung structure and function, including lung volumes, oscillometry, diffusing capacity for carbon monoxide (DLCO), and airway, blood vessel and cardiac morphology by CT. This deeper phenotyping will move the characterization of lung health reserve beyond FEV1, as well as establish a more comprehensive baseline of lung health to allow assessment of susceptibility. Furthermore, the investigators will relate these detailed measures of lung structure and function to modifiable exposures and risk factors that will allow identification of risks to lung health and potential strategies to mitigate risk. The investigators hypothesize that modifiable exposures and risk factors influence lung health by the effects on structural and functional dysanapsis of the airway, parenchyma and pulmonary vasculature, as well as cardiac morphology and gas exchange.

Connect with a study center

  • University of Alabama

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • University of California, Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • National Jewish Health

    Denver, Colorado 80206
    United States

    Active - Recruiting

  • Nemours Children's Jacksonville

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • University of Kansas

    Kansas City, Kansas 66103
    United States

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 21218
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Wake Forest School of Medicine

    Winston-Salem, North Carolina 27104
    United States

    Active - Recruiting

  • University of Pittsburgh - Emphysema/COPD Research Center

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • University of Vermont

    Burlington, Vermont 05446
    United States

    Active - Recruiting

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