Deep Functional Phenotyping of the ALA Lung Health Cohort
NCT ID: NCT06177717
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2024-02-12
2026-07-30
Brief Summary
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* 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).
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
35 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
American Lung Association
OTHER
University of Vermont
OTHER
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Meredith McCormack, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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University of Alabama
Birmingham, Alabama, United States
University of California, Los Angeles
Los Angeles, California, United States
National Jewish Health
Denver, Colorado, United States
Nemours Children's Jacksonville
Jacksonville, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Kansas
Kansas City, Kansas, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Duke University
Durham, North Carolina, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
University of Pittsburgh - Emphysema/COPD Research Center
Pittsburgh, Pennsylvania, United States
University of Vermont
Burlington, Vermont, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00273188
Identifier Type: -
Identifier Source: org_study_id
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