ClinicalTrials.gg
RecruitingNCT04543461Updated Sep 23, 2026

American Lung Association (ALA) Lung Health Cohort

An observational study in Lung Diseases, sponsored by Johns Hopkins University. Recruiting at 37 sites in United States. Open to participants aged 25 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Johns Hopkins University · Observational

From the registry’s dates

  • Started Oct 2021; still recruiting 5 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,000
Ages
25 Years to 35 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Lung Diseases by Johns Hopkins University — 4 open to participants now, 4 under way, 1 of them phase 3. Lung Diseases · Johns Hopkins University.

Started
2021
the only one that year
Observational
2 of 10
2 open now
Registered
6th of 10
by date

Among the 10 studies in Lung Diseases by Johns Hopkins University, this one is the only one that started in 2021, is one of 2 observational ones, and was the 6th registered.

By phase

10 studies; the count open now beside each. This study's row is marked.

No phase4 · 0 open
Observationalthis study2 · 2 open
Other kind1 · 0 open
Phase 21 · 1 open
Phase 31 · 1 open
Phase 41 · 0 open

By the year they started

First in 2001; this study’s year is marked. 1 started in 2021.

Size and results

Median enrollment 334 across the 7 interventional studies, 3,459 across the 3 observational. Of the 6 that completed or were terminated, 2 (33%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 10 studies in Lung Diseases by Johns Hopkins University, or all of them as a file.
02

Study 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.

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

03

Conditions studied

  • Lung Diseases

Browse trials for

Keywords

  • lung health
  • environmental exposure
  • chest CT
  • spirometry
  • biomarkers
04

Who can participate

Ages eligible
25 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Young adults between 25 and 35 year of age at baseline

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

    1. 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

    2. 3 or more unscheduled healthcare visits (provider/urgent care/ER) for asthma in the past 12 months OR
    3. One asthma hospitalization in the past 12 months
  2. History of any chronic lung disease other than asthma including but not limited to , cystic fibrosis, pulmonary fibrosis, pulmonary hypertension
  3. Current pregnancy
  4. History of cancer other than non-melanoma skin cancer
  5. Diagnosed cardiovascular diseases (i.e., congenital heart disease, coronary heart disease)
  6. Inability to comply with study procedures, including

    1. Inability or unwillingness to provide
    2. Inability to perform study measurements
    3. Inability to be contacted by phone (via calls and/or text messaging) or email
  7. 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 or severe fever at the time of the study visit).
  8. Institutionalization
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  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

    Time frame: 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

    Time frame: Baseline

07

Study locations

27 of 37 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04543461
Responsible party
Sponsor
First posted
Sep 10, 2020
Start date
Oct 29, 2021
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Sep 23, 2026

Study contacts

Elizabeth Sugar, PhD
Contact
esugar2@jhu.edu
443-287-3170
Curt Reynolds, MAS
Contact
creynol1@jhu.edu
410-614-2422
Ravi Kalhan, MD
principal investigator · Northwestern University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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