American Lung Association (ALA) Lung Health Cohort

Lung Diseases Clinical Trial

Official title:

The American Lung Association (ALA) Lung Health Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04543461
• Other study ID #: IRB00236497
• Secondary ID: U01HL146408
• Status: Recruiting
• Start date: October 29, 2021
• Est. completion date: September 2026

Study information

• Verified date: June 2024
• Source: Johns Hopkins University
• Contact: Elizabeth Sugar, PhD
• Phone: 443-287-3170
• Email: esugar2[@]jhu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	University Of Alabama	Birmingham	Alabama
United States	Brigham and Women's	Boston	Massachusetts
United States	Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York
United States	University of North Carolina Hospital	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	Rush Universtiy	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	University of Vermont	Colchester	Vermont
United States	Ohio State University	Columbus	Ohio
United States	National Jewish Health	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	New York Medical College	Hawthorne	New York
United States	Baylor College of Medicine	Houston	Texas
United States	St. Vincent's Health System	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Nemours Children's Jacksonville	Jacksonville	Florida
United States	University of Florida, 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 Wisconsin Madison	Madison	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University	New York	New York
United States	Cornell University	New York	New York
United States	Mt. Sinai, NYC	New York	New York
United States	New York University	New York	New York
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pittsburg-Emphysema/COPD Research Center	Pittsburgh	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	University of California, San Francisco	San Francisco	California
United States	University of Washington	Seattle	Washington
United States	University of Arizona-Tuscon	Tucson	Arizona
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), Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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