PiMZ Longitudinal Cohort (PiMZ Logic)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Columbia University
Study ID
NCT06505603
Status
Recruiting

Conditions

  • Alpha 1-Antitrypsin Deficiency
  • Emphysema or COPD

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

Alpha-1 Anti-trypsin Deficiency (AATD) is a genetic disease with lung and liver disease presentations. Presentations are variable in the heterozygous population, the most predominant genotype being PiMZ. The purpose of this study in PiMZ heterozygous patients is to examine the density of the lung as measured by chest computed tomography (CT) and determine if existing emphysema predicts changes in the rate of subsequent emphysema or changes in CT, serum or plasma biomarkers of interest. The overarching goal is to develop biomarkers pertinent to the PiMZ patient that can be used in interventional trials since lung function changes do not typically inform disease progression in AATD.

Key Dates

Start date
May 30, 2025
Status verified
Jan 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Emphysema
    FEV1/FVC \<70%

Primary Outcome Measure

Change in lung density over three years [ Time Frame: 3 years ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Dianne Freeman, BS, RRT
205-996-2709
Edwina Harris, MA, CRT
2049345555
James Wells, MD, MSPH (PRINCIPAL_INVESTIGATOR)
University of California- Los AngelesLos AngelesCalifornia90095
Semi Yoon
310-794-2156
Roslynn McGill
3108252616
Igor Barjaktarevic, MD, PhD (PRINCIPAL_INVESTIGATOR)
National Jewish HealthDenverColorado80206
Robert Sandhaus, MD, PhD, FCCP
Robert Sandhaus, MD, PhD, FCCP (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Vanita Patel
773-702-1012
Lyndon Fabi
7737027153
Kyle Hogarth, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical CenterNew YorkNew York10032
Sabrina Palumbo, BS
212-305-3745
Monica Goldklang, MD (PRINCIPAL_INVESTIGATOR)
Jeanine D'Armiento, MD, PhD (SUB_INVESTIGATOR)

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