Actively Recruiting
PiMZ Longitudinal Cohort (PiMZ Logic)
Led by Columbia University · Updated on 2026-01-16
80
Participants Needed
5
Research Sites
191 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
A
Alpha-1 Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PiMZ Longitudinal Cohort (PiMZ Logic)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 years and older
- Understand the study procedures, risks, benefits, and purpose
- Able and willing to comply with the study procedures
- Have PiMZ alpha-1 antitrypsin deficiency
- Post bronchodilator FEV1 less than 80% predicted AND post bronchodilator FEV1/FVC less than 70%
- Be an existing member of the Alpha-1 Foundation Clinical Cohort (Alpha-1 Foundation Research Registry)
- Agree to have the data collected shared with the Alpha-1 Foundation Research Registry
You will not qualify if you...
- AATD non-PiMZ status, including carriers
- Current lung, hematologic, or solid organ malignancy except skin or cervical Stage 1 cancers within past 3 years
- COPD exacerbation or other pulmonary infection within 6 weeks of baseline visit
- Pregnancy at time of screening
- Unable to lie still in supine position for 15 minutes during CT scan
- Unable to perform quality-controlled lung function testing
- Allergy to albuterol
- Currently receiving intravenous or subcutaneous immunoglobulin for any disease
- Past or present major lung surgery excluding wedge resections, segmentectomy, and pleurodesis
- Previous lung or liver transplant or on transplant list
- Decompensated cirrhosis
- Current presence of endobronchial coils or valves in lungs
- Clinically significant bronchiectasis with recent lung infections or colonization
- Participation in active treatment arm of therapeutic clinical trial at baseline unless using Alpha-1 augmentation therapies in alternative doses
- Has an Automatic Implantable Cardioverter Defibrillator or permanent pacemaker
- Receiving biologic immunomodulators affecting biomarker assessment
- Has pleural catheters
- Any condition that might negatively affect study outcome as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
University of California- Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
3
National Jewish Health
Denver, Colorado, United States, 80206
Not Yet Recruiting
4
University of Chicago
Chicago, Illinois, United States, 60637
Not Yet Recruiting
5
Columbia University Irving Medical Center
New York, New York, United States, 10032
Not Yet Recruiting
Research Team
S
Sabrina Palumbo, BS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here