Deep Functional Phenotyping of the ALA Lung Health Cohort

NCT06177717 | Recruiting DMC

• 2 other identifiers: IRB00273188U01HL146408-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 12

Brief 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 of blood vessels in the participants lungs and heart, and
• the participants lungs' ability to exchange gases. 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).

Conditions

Lung Diseases

Outcome Measures

Primary Outcomes (3)

• Associations with airway-parenchymal dysanapsis

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

  Baseline

• 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

  Baseline

• Associations with diffusing capacity for carbon monoxide (DLCO)

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

  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 years of age at baseline

You may qualify if:

• 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

You may not qualify if:

• 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 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
• 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

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

Study Sites (12)

University of Alabama

Birmingham, Alabama, 35294, United States

RECRUITING

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

Nemours Children's Jacksonville

Jacksonville, Florida, 32207, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

University of Kansas

Kansas City, Kansas, 66103, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21218, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27104, United States

RECRUITING

University of Pittsburgh - Emphysema/COPD Research Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

University of Vermont

Burlington, Vermont, 05446, United States

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Meredith McCormack, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meredith McCormack, MD

CONTACT

410-955-3467; mmccor16@jhmi.edu

Alexis Rea, MPH

CONTACT

443-287-8496; area5@jhu.edu

Study Design

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

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: February 12, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be made available indefinitely upon completion of the study (anticipated 6/30/2028).

Locations

US (12)