Understanding lung health in young adults

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

This study is trying to learn more about lung health in healthy young adults aged 25 to 35 by testing how well their lungs work and what might affect their risk of lung disease.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 25 Years to 35 Years
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 12 sites (Birmingham, Alabama and 11 other locations)
• Trial ID: NCT06177717 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate lung structure and function in a cohort of 1000 healthy individuals aged 25 to 35. Participants will undergo four different lung function tests to assess various aspects of lung health, including air movement, lung size, and gas exchange capabilities. The study leverages the infrastructure of the American Lung Association's Airways Clinical Research Centers to form a national cohort focused on respiratory health, examining factors that may influence lung disease susceptibility. By analyzing these factors, the study seeks to establish a comprehensive understanding of lung health and identify early indicators of chronic lung disease.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 25 to 35 who can read and understand English or Spanish and have been residents of the U.S. for at least 12 months.

Not a fit: Patients with severe asthma or other significant lung diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into lung health that may help prevent chronic lung diseases in young adults.

How similar studies have performed: Other studies focusing on lung health and function in similar populations have shown promise, but this specific approach of deep phenotyping is relatively novel.

Eligibility criteria

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

Where this trial is running

Birmingham, Alabama and 11 other locations

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

Study contacts

• Principal investigator: Meredith McCormack, MD — Johns Hopkins University
• Study coordinator: Meredith McCormack, MD

Conditions Lung Diseases