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Lung DiseasesDLP-LHCNCT06177717

Deep Functional Phenotyping of the ALA Lung Health Cohort

An observational study of Lung Diseases, run by Johns Hopkins University at 12 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 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… 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
1,000 participants
Where
12 sitesUnited States
Study dates
12 Feb 2024to 30 Mar 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 years of age at baseline

Who may be able to join

  • 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 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.
  • 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) Global Initiative for Asthma (GINA) Step 4 or higher therapy (medium dose inhaled corticosteroid/long-acting beta agonist (ICS/LABA) or high dose inhaled corticosteroid [ICS] or add-on long-acting muscarinic antagonist (LAMA); Medium dose = >250 fluticasone, propionate =100 fluticasone furoate, >200 beclomethasone, >400 budesonide, >220 mometasone). The investigators 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 chronic obstructive pulmonary disease (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

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

Meredith McCormack, MD contact

410-955-3467

mmccor16@jhmi.edu

Alexis Rea, MPH contact

443-287-8496

area5@jhu.edu

12 sites in 1 country

United States12 sites, 12 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

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

    MeiLan Han, MD

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21218

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

    Nadia Hansel, MD

    Recruiting

  • University of Alabama

    Birmingham, Alabama, 35294

    Michelle Williams, 205-934-6683, michellewilliams@uabmc.edu

    Mark Dransfield, MD

    Recruiting

  • University of Vermont

    Burlington, Vermont, 05446

    Olivia Garrow, 802-847-2160, olivia.johnson@uvmhealth.org

    Charles Irvin, PhD

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

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

    Ravi Kalhan, MD

    Recruiting

  • National Jewish Health

    Denver, Colorado, 80206

    Madeleine Caruso, 303-398-1443, CARUSOM@NJHEALTH.ORG

    Barry Make, MD

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

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

    Loretta Que, MD

    Recruiting

  • Nemours Children's Jacksonville

    Jacksonville, Florida, 32207

    Julia Krutov, 904-697-3925, biomedicalresearch@nemours.org

    Kathryn Blake, PharmD

    Recruiting

  • University of Kansas

    Kansas City, Kansas, 66103

    John McLean, 913-574-0176, jmclean@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, MD

    Recruiting

  • University of Pittsburgh - Emphysema/COPD Research Center

    Pittsburgh, Pennsylvania, 15213

    Casey Rapoza, 412-692-4876, rapozaca@upmc.edu

    Frank Sciurba, MD

    Recruiting

  • Wake Forest School of Medicine

    Winston-Salem, North Carolina, 27104

    Abby Paust, 336-713-8550, apaust@wakehealth.edu

    Wendy Moore, MD

    Recruiting

Other trials in United States

About this study

Official title: The American Lung Association (ALA) Deep Phenotyping Ancillary Study of the Lung Health Cohort (LHC)

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.
Read more

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).
Read the detailed 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.

Conditions
Lung Diseases
Medical subject headings
Lung Diseases

What is being measured

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

  1. Associations with airway-parenchymal dysanapsis

    Correlation of adverse modifiable exposures and risk factors with increased airway-parenchymal dysanapsis

    Measured: Baseline

  2. Associations with vascular parenchymal dysanapsis and cardiac chamber size

    Correlation of adverse modifiable exposures and risk factors with increased vascular parenchymal dysanapsis and increased cardiac chamber size

    Measured: Baseline

  3. Associations with diffusing capacity for carbon monoxide (DLCO)

    Correlation of adverse modifiable exposures and risk factors with lower diffusing capacity for carbon monoxide (DLCO)

    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 posted20 Dec 2023
  2. Study start12 Feb 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Mar 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
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06177717
Sponsor's protocol ID
IRB00273188
Other IDs
U01HL146408-01
Acronym
DLP-LHC
Status last verified
Jul 2026
First submitted
11 Dec 2023
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified study data will be made available to researchers by publishing on a data sharing site. Data will be made available upon completion of the study and publication of the summary paper.

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Diseases, run by Johns Hopkins University at 12 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 6 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 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 Meredith McCormack, MD (410-955-3467, mmccor16@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Associations with airway-parenchymal dysanapsis (time frame: Baseline). The study lists 3 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 NCT06177717.

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 17 Jul 2026.

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