NCT06505603Recruiting
PiMZ Longitudinal Cohort (PiMZ Logic)
Alpha-1 Antitrypsin PiMZ Longitudinal Cohort (PiMZ Logic)
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 11 Jul 2024
- Start date
- 30 May 2025
- Primary completion date
- Feb 2029
- Lead sponsor
- Columbia University
- Diseases
- COPD
- NCT number
- NCT06505603
What you commit to
- Study type: Observational
- Planned participants: 80
- From 30 May 2025 to the primary completion date, Feb 2029
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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.
Other illness
- 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
- Allergy to albuterol
- 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.
- Any condition that in the opinion of the investigator might adversely influence the study outcome
Lab values
- Patient receiving biologic immunomodulators that will affect the assessment of the serum biomarkers (as determined by the site PI)
Other
- AATD non-PiMZ status, including carriers
- 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
- Decompensated cirrhosis
- Current presence of endobronchial coils or valves in the lung
- Patient with Automatic Implantable Cardioverter Defibrillator (AICD) and permanent pacemakers (PPM)
- Patient with pleural catheters
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Not yet recruiting |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Not yet recruiting |
| National Jewish Health Coordinator of this site? Confirm its status | Denver | United States | Not yet recruiting |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.