Deep Functional Phenotyping of the ALA Lung Health Cohort

Lung Diseases Clinical Trial

— DLP-LHC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06177717
• Other study ID #: IRB00273188
• Secondary ID: U01HL146408-01
• Status: Recruiting
• Start date: February 12, 2024
• Est. completion date: July 2026

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: Meredith McCormack, MD
• Phone: 410-955-3467
• Email: mmccor16[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

1. 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

2. 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

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

• 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

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

Related Conditions & MeSH terms

• Lung Diseases

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	University of Vermont	Burlington	Vermont
United States	Northwestern University	Chicago	Illinois
United States	National Jewish Health	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	Nemours Children's Jacksonville	Jacksonville	Florida
United States	University of Kansas	Kansas City	Kansas
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Pittsburgh - Emphysema/COPD Research Center	Pittsburgh	Pennsylvania
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	American Lung Association, National Heart, Lung, and Blood Institute (NHLBI), University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Associations with airway-parenchymal dysanapsis	Correlation of adverse modifiable exposures and risk factors with increased airway-parenchymal dysanapsis	Baseline
Primary	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
Primary	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