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Lung DiseasesNCT04543461

American Lung Association (ALA) Lung Health Cohort

An observational study of Lung Diseases, run by Johns Hopkins University at 37 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 25 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Lung Diseases
How many people
4,000 participants
Where
37 sitesUnited States
Study dates
29 Oct 2021to 30 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Young adults between 25 and 35 year of age at baseline

Who may be able to join

  • 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

Who cannot join

  • Severe asthma, which is defined as any of the following:
  • 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
  • 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
Show all 15Show fewer
  • Current pregnancy
  • History of cancer other than non-melanoma skin cancer
  • Diagnosed cardiovascular diseases (i.e., congenital heart disease, coronary heart disease)
  • 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
  • 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).
  • Institutionalization

Trial locations and contacts

37 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Elizabeth Sugar, PhD contact

443-287-3170

esugar2@jhu.edu

Curt Reynolds, MAS contact

410-614-2422

creynol1@jhu.edu

37 sites in 1 country

United States37 sites, 30 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Wendy Warshal, 734-232-2841, warshal@med.umich.edu

    abaptist@med.umich.edu

    Recruiting

  • University of Colorado

    Aurora, Colorado, 80045

    Active, not recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21218

    Molly Lauver, 410-550-2863, mlauver3@jhmi.edu

    Nadia Hansel

    Recruiting

  • University Of Alabama

    Birmingham, Alabama, 35294

    Necole Harris, 205-934-9240, itis-lhc@uab.edu

    Michael Wells, MD

    Recruiting

  • Brigham and Women's

    Boston, Massachusetts, 02115

    Withdrawn

  • Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

    718-780-5906, che2018@nyp.org

    Jerem Weingarten, MD, MBA, MS

    Not yet recruiting

  • University of North Carolina Hospital

    Chapel Hill, North Carolina, 27517

    Suspended

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Kristin Neff, 843-792-1219, neffk@musc.edu

    Charlie Strange, MD

    Recruiting

  • University of Illinois at Chicago

    Chicago, Illinois, 60608

    Lourdes Norwick, 312-413-5453, lhc_study@uic.edu

    Lynn Gerald, PhD

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Shafic Kakooza, 312-503-6378, lhc@northwestern.edu

    Ravi Kalhan, MD

    Recruiting

  • Rush Universtiy

    Chicago, Illinois, 60612

    Jessica Parumoottil, 312-563-2168, Jessica_Parumoottil@rush.edu

    James Moy, MD

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Withdrawn

  • University of Vermont

    Colchester, Vermont, 05446

    Grahm Janson, 802-847-2193, Graham.Janson@uvmhealth.org

    Charles Irvin, PhD

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Joseph Santiago, 614-293-4925, Joseph.Santiago@osumc.edu

    Philip Diaz

    Recruiting

  • National Jewish Health

    Denver, Colorado, 80206

    Juno Pak, 303-398-1443, PakJ@NJHealth.org

    Barry Make, MD

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Kaitlin Foy, 919-479-0861, DukeAirwayResearch@duke.edu

    Loretta Que, MD

    Recruiting

  • New York Medical College

    Hawthorne, New York, 10532

    Zachary Messer, 914-593-8904, zachary_messer@nymc.edu

    Allen Dozor, MD

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Laura Bertrand, 713-798-2681, Laura.Bertrand@bcm.edu

    Nicola Hanania, MD

    Recruiting

  • St. Vincent's Health System

    Indianapolis, Indiana, 46260

    Withdrawn

  • University of Iowa

    Iowa City, Iowa, 52242

    Eric Garcia, 319-353-8862, eric-garcia@uiowa.edu

    Alejandro Comellas, MD

    Recruiting

  • Nemours Children's Jacksonville

    Jacksonville, Florida, 32207

    Micheal Littlefield, 904-697-3925, Biomedicalresearch@nemours.org

    Kathryn Blake, PharmD

    Recruiting

  • University of Florida, Jacksonville

    Jacksonville, Florida, 32209

    Jennifer Bowman, 904-244-1106, Jennifer.Bowman@jax.ufl.edu

    Vandana Seeram, MD

    Recruiting

  • University of Kansas

    Kansas City, Kansas, 66103

    Nicole Hall, 913-588-1987, nhall@kumc.edu

    Mario Castro, MD, MPH

    Recruiting

  • University of California, Los Angeles

    Los Angeles, California, 90095

    Tiffany Bina, 310-206-1629, tbina@mednet.ucla.edu

    Igor Barjaktarevic

    Recruiting

  • University of Wisconsin Madison

    Madison, Wisconsin, 53792

    Withdrawn

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37235

    Courtney Lehman, 615-421-8172, courtney.a.lehman@vumc.org

    Leonard Bacharier

    Recruiting

  • New York University

    New York, New York, 10016

    Withdrawn

  • Mt. Sinai, NYC

    New York, New York, 10029

    Maria Wong, 212-241-2779, mariaantonia.wong@mssm.edu

    Linda Rogers, MD

    Recruiting

  • Columbia University

    New York, New York, 10032

    Tarnjot Saroya, 212-305-0251, tks2127@cumc.columbia.edu

    Emily DiMango, MD

    Not yet recruiting

  • Cornell University

    New York, New York, 10032

    Alicia Morris, MS, 646-962-2741, ajm2017@med.cornell.edu

    Robert Kaner

    Recruiting

  • Temple University

    Philadelphia, Pennsylvania, 19140

    Sally Quinn, 215-707-1359, breathe@tuhs.temple.edu

    Nathaniel Marchetti, MD

    Recruiting

  • University of Pittsburg-Emphysema/COPD Research Center

    Pittsburgh, Pennsylvania, 15213

    Tiffany Ditter, 412-648-6495, dittertl2@upmc.edu

    Elizabeth Stempkowski

    Recruiting

  • University of Rochester

    Rochester, New York, 14642

    585-369-6769, LHC@URMC.Rochester.edu

    Sandhya Khurana, MD

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Shannen Recio, 415-203-8234, shannen.recio@ucsf.edu

    Stephanie Christenson, MD

    Recruiting

  • University of Washington

    Seattle, Washington, 98108

    206-764-2558, dau@uw.edu

    David Au, MD

    Not yet recruiting

  • University of Arizona-Tuscon

    Tucson, Arizona, 85724

    Alyssandra Rivera, 520-626-6387, arivera59@arizona.edu

    Fernando Martinez, PhD, MSPH

    Recruiting

  • Wake Forest School of Medicine

    Winston-Salem, North Carolina, 27104

    Isaac Deaton, 336-713-8550, ideaton@wakehealth.edu

    Wendy Moore, MD

    Recruiting

Other trials in United States

About this study

Official title: The American Lung Association (ALA) Lung Health Cohort

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.

Read the 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

Conditions
Lung Diseases
Keywords
lung health, environmental exposure, chest CT, spirometry, biomarkers
Medical subject headings
Lung Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline

  2. 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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2020
  2. Study start29 Oct 2021
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04543461
Sponsor's protocol ID
IRB00236497
Other IDs
U01HL146408
Status last verified
Sep 2026
First submitted
2 Sep 2020
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Diseases, run by Johns Hopkins University at 37 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elizabeth Sugar, PhD (443-287-3170, esugar2@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre-bronchodilator measurement of Forced Expiratory Volume in one second (FEV1) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04543461.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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