Longitudinal study on lung health in young adults
The American Lung Association (ALA) Lung Health Cohort
This study is looking at how things like the environment, exercise, and health markers affect lung health in young adults aged 25-35 over the next few years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 25 Years to 35 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 37 sites (Birmingham, Alabama and 36 other locations) |
| Trial ID | NCT04543461 on ClinicalTrials.gov |
What this trial studies
The ALA Lung Health Cohort is a multi-center observational study enrolling around 4,000 young adults aged 25-35 without severe lung disease. The study aims to explore the relationship between various factors such as environmental exposures, physical activity, and biomarkers on lung health. Participants will undergo baseline assessments and receive regular follow-ups over 4.5 years to gather data on their lung health. If additional funding is secured, the study may extend to investigate long-term changes in lung health beyond five years.
Who should consider this trial
Good fit: Ideal candidates are young adults aged 25-35 who are residents of the U.S. and do not have severe lung disease.
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 help identify early interventions to prevent chronic lung diseases in young adults.
How similar studies have performed: Other studies focusing on lung health in young populations have shown promise, but this specific cohort approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama and 36 other locations
- University Of Alabama — Birmingham, Alabama, United States (Recruiting)
- University of Arizona-Tuscon — Tucson, Arizona, United States (Recruiting)
- University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- University of Colorado — Aurora, Colorado, United States (Active_not_recruiting)
- National Jewish Health — Denver, Colorado, United States (Recruiting)
- Nemours Children's Jacksonville — Jacksonville, Florida, United States (Recruiting)
- University of Florida, Jacksonville — Jacksonville, Florida, United States (Recruiting)
- University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Rush Universtiy — Chicago, Illinois, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Withdrawn)
- St. Vincent's Health System — Indianapolis, Indiana, United States (Withdrawn)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- University of Kansas — Kansas City, Kansas, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Brigham and Women's — Boston, Massachusetts, United States (Withdrawn)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York, United States (Not_yet_recruiting)
- New York Medical College — Hawthorne, New York, United States (Recruiting)
- New York University — New York, New York, United States (Withdrawn)
- Mt. Sinai, NYC — New York, New York, United States (Recruiting)
- Columbia University — New York, New York, United States (Not_yet_recruiting)
- Cornell University — New York, New York, United States (Recruiting)
- University of Rochester — Rochester, New York, United States (Recruiting)
- University of North Carolina Hospital — Chapel Hill, North Carolina, United States (Active_not_recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- Wake Forest School of Medicine — Winston-Salem, North Carolina, United States (Recruiting)
- Ohio State University — Columbus, Ohio, United States (Recruiting)
- Temple University — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pittsburg-Emphysema/COPD Research Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- University of Vermont — Colchester, Vermont, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Not_yet_recruiting)
- University of Wisconsin Madison — Madison, Wisconsin, United States (Withdrawn)
Study contacts
- Principal investigator: Ravi Kalhan, MD — Northwestern University
- Study coordinator: Elizabeth Sugar, PhD
- Email: esugar2@jhu.edu
- Phone: 443-287-3170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.