Status:
NOT_YET_RECRUITING
PiMZ Longitudinal Cohort (PiMZ Logic)
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Alpha-1 Foundation
Conditions:
Alpha 1-Antitrypsin Deficiency
Emphysema or COPD
Eligibility:
All Genders
18+ years
Brief Summary
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 Pi...
Detailed Description
Progression of lung disease in patients with Alpha-1 Anti-trypsin deficiency is variable and while some patients may have stable lung function over many years, some progress and deteriorate rapidly. C...
Eligibility Criteria
Inclusion
- Males and females aged 18 years and older
- Understand the study procedures, risks, benefits, purpose
- Able and willing to comply with the study procedures
- Have PiMZ alpha-1 antitrypsin deficiency
- Post bronchodilator FEV1 \< 80% predicted AND post bronchodilator FEV1/FVC \< 70%
- Be an existing member of the Alpha-1 Foundation Clinical Cohort (also known as the Alpha-1 Foundation Research Registry)
- Agree to have the data collected in this study be shared with the Alpha-1 Foundation Research Registry
Exclusion
- AATD non-PiMZ status, including carriers
- Current lung, hematologic, or solid organ malignancy other than skin or cervical Stage 1 cancers within the past 3 years
- COPD exacerbation or other pulmonary infection within 6 weeks of baseline visit
- Pregnancy at the time of the screening visit
- Inability to lie still in a supine position for 15 minutes during CT acquisition
- Inability to perform quality-controlled lung function testing
- Allergy to albuterol
- Currently receiving intravenous or subcutaneous immunoglobulin for any disease state
- Past or present major surgery on the lungs including pneumonectomy or lobectomy. Wedge resections, past segmentectomy, and pleurodesis surgeries are allowed.
- Previous lung or liver transplantation or currently on the transplant list
- Decompensated cirrhosis
- Current presence of endobronchial coils or valves in the lung
- Clinically significant bronchiectasis as defined by the investigator. In general, this would exclude patients with chronic infection of the lungs requiring treatment within the past 6 months including non-tuberculous mycobacterial disease, chronic fungal disease, allergic bronchopulmonary aspergillosis, or known colonization of bronchiectasis with pseudomonas or stenotrophomonas species.
- Participation in the active treatment arm of a therapeutic clinical trial at baseline visit unless using one of the Alpha-1 augmentation therapies in alternative doses.
- Patient with Automatic Implantable Cardioverter Defibrillator (AICD) and permanent pacemakers (PPM)
- Patient receiving biologic immunomodulators that will affect the assessment of the serum biomarkers (as determined by the site PI)
- Patient with pleural catheters
- Any condition that in the opinion of the investigator might adversely influence the study outcome
Key Trial Info
Start Date :
December 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06505603
Start Date
December 1 2025
End Date
February 1 2029
Last Update
May 20 2025
Active Locations (5)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of California- Los Angeles
Los Angeles, California, United States, 90095
3
National Jewish Health
Denver, Colorado, United States, 80206
4
University of Chicago
Chicago, Illinois, United States, 60637