American Lung Association (ALA) Lung Health Cohort

The American Lung Association (ALA) Lung Health Cohort

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.

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Elizabeth Sugar, PhD; Phone Number: 443-287-3170; Email: esugar2@jhu.edu
• Study Contact Backup: Name: Curt Reynolds, MAS; Phone Number: 410-614-2422; Email: creynol1@jhu.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama
      • Principal Investigator: Mark Dransfield, MD
      • Contact: Michelle Williams; Phone Number: 205-934-6683; Email: itis-lhc@uab.edu
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Recruiting
      • University of Arizona-Tuscon
      • Contact: Raymond Skeps; Phone Number: 520-626-5590; Email: chelseylarge@arizona.edu
      • Principal Investigator: Lynn Gerald, PhD, MSPH
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California, Los Angeles
      • Contact: Tiffany Bina; Phone Number: 310-206-1629; Email: tbina@mednet.ucla.edu
      • Principal Investigator: Igor Barjaktarevic
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Shannen Recio; Phone Number: 415-203-8234; Email: shannen.recio@ucsf.edu
      • Principal Investigator: Stephanie Christenson, MD
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado
      • Contact: Tumin Yifru; Phone Number: 844-365-0852; Email: asthmaresearch@ucdenver.edu
      • Principal Investigator: Richard Vandivier, MD
    • Denver, Colorado, United States, 80206
      • Recruiting
      • National Jewish Health
      • Contact: Madeline Caruso; Phone Number: 303-398-1443; Email: carusom@njhealth.org
      • Principal Investigator: Barry Make, MD
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Nemours Children's Jacksonville
      • Contact: Julia Krutov; Phone Number: 904-697-3925; Email: biomedicalresearch@nemours.org
      • Principal Investigator: Kathryn Blake, PharmD
    • Jacksonville, Florida, United States, 32209
      • Recruiting
      • University of Florida, Jacksonville
      • Principal Investigator: Vandana Seeram, MD
      • Contact: Phone Number: 904-244-1106; Email: vandana.seeram@jax.ufj.edu
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Shafic Kakooza; Phone Number: 312-503-6378; Email: lhc@northwestern.edu
      • Principal Investigator: Ravi Kalhan, MD
      • Principal Investigator: Lewis Smith, MD
    • Chicago, Illinois, United States, 60637
      • Active, not recruiting
      • University of Chicago
    • Chicago, Illinois, United States, 60608
      • Recruiting
      • University of Illinois at Chicago
      • Contact: Debby Cogley; Phone Number: 855-494-3393; Email: lhc_study@uic.edu
      • Principal Investigator: Lynn Gerald, PhD
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush Universtiy
      • Principal Investigator: James Moy, MD
      • Contact: Jun Fu; Phone Number: 312-942-6352; Email: Jun_Fu@rush.edu
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Withdrawn
      • St. Vincent's Health System
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa
      • Contact: Eric Garcia; Phone Number: 319-353-8862; Email: eric-garcia@uiowa.edu
      • Principal Investigator: Alejandro Comellas, MD
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • Recruiting
      • University of Kansas
      • Principal Investigator: Mario Castro, MD, MPH
      • Contact: John McLean; Phone Number: 913-574-0176; Email: jmclean@kumc.edu
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Recruiting
      • Johns Hopkins University
      • Contact: Molly Lauver; Phone Number: 410-550-2863; Email: mlauver3@jhmi.edu
      • Principal Investigator: Nadia Hansel
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Withdrawn
      • Brigham and Women's
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Principal Investigator: Meilan Han, MD
      • Contact: Mary Kay Hamby; Phone Number: 734-232-2841; Email: mkhamby@med.umich.edu
      • Contact: Email: abaptist@med.umich.edu
      • Principal Investigator: Alan Baptist, MD, MPH
  • New York
    • Brooklyn, New York, United States, 11215
      • Not yet recruiting
      • Presbyterian Brooklyn Methodist Hospital
      • Contact: Phone Number: 718-780-5906; Email: che2018@nyp.org
      • Principal Investigator: Jerem Weingarten, MD, MBA, MS
    • Hawthorne, New York, United States, 10532
      • Not yet recruiting
      • New York Medical College
      • Contact: Zachary Messer; Phone Number: 914-593-8904; Email: zachary_messer@nymc.edu
      • Principal Investigator: Allen Dozor, MD
    • New York, New York, United States, 10032
      • Not yet recruiting
      • Columbia University
      • Principal Investigator: Emily DiMango, MD
      • Contact: Tarnjot Saroya; Phone Number: 212-305-0251; Email: tks2127@cumc.columbia.edu
    • New York, New York, United States, 10016
      • Withdrawn
      • New York University
    • New York, New York, United States, 10029
      • Recruiting
      • Mt. Sinai, NYC
      • Contact: Phone Number: 212-241-2779; Email: linda.rogers@mssm.edu
      • Principal Investigator: Linda Rogers, MD
    • New York, New York, United States, 10032
      • Not yet recruiting
      • Cornell University
      • Contact: Phone Number: 212-305-4675; Email: rkaner@med.cornell.edu
      • Principal Investigator: Robert Kaner
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester
      • Contact: Phone Number: 585-369-6769; Email: LHC@URMC.Rochester.edu
      • Principal Investigator: Sandhya Khurana, MD
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • Recruiting
      • University of North Carolina Hospital
      • Contact: Caleb Hemphill; Phone Number: 984-974-2969; Email: caleb_hemphill@med.unc.edu
      • Principal Investigator: Bradley Drummond, MD
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University
      • Contact: Kaitlin Foy; Phone Number: 919-479-0861; Email: DukeAirwayResearch@duke.edu
      • Principal Investigator: Loretta Que, MD
    • Winston-Salem, North Carolina, United States, 27104
      • Recruiting
      • Wake Forest School of Medicine
      • Contact: Isaac Deaton; Phone Number: 336-713-8550; Email: ideaton@wakehealth.edu
      • Principal Investigator: Wendy Moore, MD
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
      • Contact: Janice Drake; Phone Number: 614-366-2186; Email: LungResearch@osumc.edu
      • Principal Investigator: Philip Diaz
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • Temple University
      • Contact: Sally Quinn; Phone Number: 215-707-1359; Email: breathe@tuhs.temple.edu
      • Principal Investigator: Nathaniel Marchetti, MD
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburg-Emphysema/COPD Research Center
      • Principal Investigator: Frank Sciurba, MD
      • Contact: Dominic Kramer; Phone Number: 866-948-2673; Email: ecrc@upmc.edu
      • Contact: Elizabeth Stempkowski
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Principal Investigator: Charlie Strange, MD
      • Contact: Kristin Neff; Phone Number: 843-792-1219; Email: neffk@musc.edu
  • Tennessee
    • Nashville, Tennessee, United States, 37235
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Julie Madison; Phone Number: 615-421-8328; Email: julie.l.madison@vumc.org
      • Principal Investigator: Leonard Bacharier
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Contact: Laura Bertrand; Phone Number: 713-798-2681; Email: Laura.Bertrand@bcm.edu
      • Principal Investigator: Nicola Hanania, MD
  • Vermont
    • Colchester, Vermont, United States, 05446
      • Recruiting
      • University of Vermont
      • Contact: Cory Raymond; Phone Number: 802-847-2193; Email: cory.raymond@uvmhealth.org
      • Principal Investigator: Charles Irvin, PhD
  • Washington
    • Seattle, Washington, United States, 98108
      • Not yet recruiting
      • University of Washington
      • Contact: Phone Number: 206-764-2558; Email: dau@uw.edu
      • Principal Investigator: David Au, MD
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Withdrawn
      • University of Wisconsin Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 33 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Young adults between 25 and 35 year of age at baseline

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Stanford University; American Lung Association
• Investigators: Principal Investigator: Ravi Kalhan, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2021
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: biomarkers; spirometry; environmental exposure; lung health; chest CT
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: IRB00236497; U01HL146408 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No