American Lung Association (ALA) Lung Health Cohort

NCT04543461 | Recruiting DMC

• 2 other identifiers: IRB00236497U01HL146408
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 37

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline

• 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

  Baseline

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Young adults between 25 and 35 year of age at baseline

You may qualify if:

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

You may not qualify if:

• 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 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
• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• American Lung Association: collaborator
• Stanford University: collaborator

Study Sites (37)

University Of Alabama

Birmingham, Alabama, 35294, United States

RECRUITING

University of Arizona-Tuscon

Tucson, Arizona, 85724, United States

RECRUITING

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

University of Colorado

Aurora, Colorado, 80045, United States

ACTIVE NOT RECRUITING

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

Nemours Children's Jacksonville

Jacksonville, Florida, 32207, United States

RECRUITING

University of Florida, Jacksonville

Jacksonville, Florida, 32209, United States

RECRUITING

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Rush Universtiy

Chicago, Illinois, 60612, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

WITHDRAWN

St. Vincent's Health System

Indianapolis, Indiana, 46260, United States

WITHDRAWN

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kansas

Kansas City, Kansas, 66103, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21218, United States

RECRUITING

Brigham and Women's

Boston, Massachusetts, 02115, United States

WITHDRAWN

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

NOT YET RECRUITING

New York Medical College

Hawthorne, New York, 10532, United States

RECRUITING

New York University

New York, New York, 10016, United States

WITHDRAWN

Mt. Sinai, NYC

New York, New York, 10029, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

NOT YET RECRUITING

Cornell University

New York, New York, 10032, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

University of North Carolina Hospital

Chapel Hill, North Carolina, 27517, United States

ACTIVE NOT RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27104, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Temple University

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

University of Pittsburg-Emphysema/COPD Research Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37235, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

University of Vermont

Colchester, Vermont, 05446, United States

RECRUITING

University of Washington

Seattle, Washington, 98108, United States

NOT YET RECRUITING

University of Wisconsin Madison

Madison, Wisconsin, 53792, United States

WITHDRAWN

Biospecimen

Retention: SAMPLES WITH DNA

plasma, serum, urine, nasal curettage, nasosorption strips

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Ravi Kalhan, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Sugar, PhD

CONTACT

443-287-3170; esugar2@jhu.edu

Curt Reynolds, MAS

CONTACT

410-614-2422; creynol1@jhu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 10, 2020
• Study Start: October 29, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (37)