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American Lung Association (ALA) Lung Health Cohort

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ClinicalTrials.gov Identifier: NCT04543461
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : December 15, 2022
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
American Lung Association
Stanford University
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Brief 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.

Condition or disease
Lung Diseases

Detailed 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
Study Design
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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The American Lung Association (ALA) Lung Health Cohort
Actual Study Start Date : October 29, 2021
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Pre-bronchodilator measurement of Forced Expiratory Volume in one second (FEV1) [ Time Frame: Baseline ]
    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

  2. Pre-bronchodilator measurements of Forced Vital Capacity (FVC) [ Time Frame: Baseline ]
    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


Biospecimen Retention:   Samples With DNA
plasma, serum, urine, nasal curettage, nasosorption strips

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Young adults between 25 and 35 year of age at baseline
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04543461


Contacts
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Contact: Elizabeth Sugar, PhD 443-287-3170 esugar2@jhu.edu
Contact: Curt Reynolds, MAS 410-614-2422 creynol1@jhu.edu

Locations
Show Show 37 study locations
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
American Lung Association
Stanford University
Investigators
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Principal Investigator: Ravi Kalhan, MD Northwestern University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04543461    
Other Study ID Numbers: IRB00236497
U01HL146408 ( U.S. NIH Grant/Contract )
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: December 15, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
lung health
environmental exposure
chest CT
spirometry
biomarkers
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases