Actively Recruiting
Alpha-1 Antitrypsin PiMZ Longitudinal Cohort Study to Track Lung Disease Progression
Led by Columbia University · Updated on 2026-01-16
80
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
A
Alpha-1 Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying lung disease progression in people with Alpha-1 Anti-trypsin Deficiency (AATD), focusing on those with the PiMZ genotype. This genetic condition can cause lung and liver problems, and its effects vary among individuals. The goal is to find early signs in lung scans and blood or sputum tests that predict worsening lung disease in these patients, as traditional lung function tests may not always reflect disease progression accurately. The study follows a group of PiMZ patients with obstructive lung disease over three years. Participants will undergo detailed lung imaging using high-resolution CT scans at the start and again at 18 and 36 months. Blood and sputum samples will be collected to measure various biomarkers. Participants also complete questionnaires about their lung health, including monthly surveys about exacerbations. These procedures help researchers track changes in lung density and other markers over time. Participants will have their medical and medication histories reviewed and perform lung function tests such as spirometry at each visit. The study will assess changes in lung density and lung function decline, using CT imaging and biomarker data to identify early signs of worsening emphysema. The total study duration for each participant is three years, with regular follow-ups to monitor lung health and disease progression.
CONDITIONS
Brief 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 and agree to study procedures, risks, benefits, and purpose
- Able and willing to follow study procedures
- Have confirmed PiMZ alpha-1 antitrypsin deficiency
- Post bronchodilator FEV1 less than 80% predicted and FEV1/FVC ratio less than 70%
- Current member of the Alpha-1 Foundation Clinical Cohort or Research Registry
- Agree to share data with the Alpha-1 Foundation Research Registry
You will not qualify if you...
- Non-PiMZ alpha-1 antitrypsin deficiency status, including carriers
- Current lung, blood, or solid organ cancer except certain early-stage skin or cervical cancers within 3 years
- Lung infection or COPD exacerbation within 6 weeks before the first visit
- Pregnancy at screening
- Unable to lie still in a supine position for 15 minutes during CT scan
- Unable to perform quality lung function tests
- Allergy to albuterol
- Receiving intravenous or subcutaneous immunoglobulin treatment
- Major past or present lung surgery (except some minor surgeries)
- Previous or planned lung or liver transplant
- Decompensated liver cirrhosis
- Presence of lung coils or valves
- Significant bronchiectasis with recent infections
- Active participation in other therapeutic trials (except certain alpha-1 therapies)
- Having an implantable cardioverter defibrillator or permanent pacemaker
- Receiving biologic immunomodulators affecting biomarkers
- Having pleural catheters
- Any condition that may interfere with study outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo baseline assessments including medical history review, blood draw, spirometry, induced sputum (at some sites), completion of questionnaires, and a high resolution CT chest scan.
1 visit (in-person)
Duration - 3 years
Participants are followed longitudinally to assess lung disease progression with repeated assessments at 18 months and 36 months including blood draw, spirometry, induced sputum (at some sites), questionnaires, and high resolution CT chest scans. Additionally, participants complete monthly Alpha-net exacerbation questionnaires.
Assessments at enrollment, 18 months, and 36 months; monthly questionnaires
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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