Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT04543461

Conditions

Lung Diseases

Eligibility Criteria

Sex: All

Age: 25 - 35

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Lung Diseases

Study ID

NCT04543461

Start date

Oct 29, 2021

Status verified date

Sep, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 35

Healthy Volunteers: Accepted

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:

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 COPD, 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 informed consent
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 steroids or severe fever at the time of the study visit).
8. Institutionalization

Study Design

Enrollment

4000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Pre-bronchodilator measurement of Forced Expiratory Volume in one second (FEV1) [ Time Frame: Baseline ]
  • Pre-bronchodilator measurements of Forced Vital Capacity (FVC) [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Elizabeth Sugar, PhD

443-287-3170esugar2@jhu.edu

Locations

University Of Alabama

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Principal Investigator:

Michael Wells, MD

University of Arizona-Tuscon

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Principal Investigator:

Fernando Martinez, PhD, MSPH

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator:

Igor Barjaktarevic

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Stephanie Christenson, MD

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Principal Investigator:

Barry Make, MD

Nemours Children's Jacksonville

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Principal Investigator:

Kathryn Blake, PharmD

University of Florida, Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Principal Investigator:

Vandana Seeram, MD

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60608

Contacts

Principal Investigator:

Lynn Gerald, PhD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Ravi Kalhan, MD

Rush Universtiy

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Principal Investigator:

James Moy, MD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Principal Investigator:

Alejandro Comellas, MD

University of Kansas

Recruiting

Kansas City, Kansas, United States, 66103

Contacts

Principal Investigator:

Mario Castro, MD, MPH

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Principal Investigator:

Nadia Hansel

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

MeiLan Han, MD

New York Medical College

Recruiting

Hawthorne, New York, United States, 10532

Contacts

Principal Investigator:

Allen Dozor, MD

Mt. Sinai, NYC

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Linda Rogers, MD

Cornell University

Recruiting

New York, New York, United States, 10032

Contacts

Principal Investigator:

Robert Kaner

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Principal Investigator:

Sandhya Khurana, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Principal Investigator:

Loretta Que, MD

Wake Forest School of Medicine

Recruiting

Winston-Salem, North Carolina, United States, 27104

Contacts

Principal Investigator:

Wendy Moore, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Philip Diaz

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Principal Investigator:

Nathaniel Marchetti, MD

University of Pittsburg-Emphysema/COPD Research Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Principal Investigator:

Frank Sciurba, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator:

Charlie Strange, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37235

Contacts

Principal Investigator:

Leonard Bacharier

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Nicola Hanania, MD

University of Vermont

Recruiting

Colchester, Vermont, United States, 05446

Contacts

Principal Investigator:

Charles Irvin, PhD

More Information

Sponsor

Johns Hopkins University

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-12. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.