Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2025-05-30
2029-02-28
Brief Summary
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Detailed Description
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Study procedures include: Review of medical history and medication history, blood draw, spriometry, induced sputum (at some sites), completion of questionnaires and CT Chest scan. All of the mentioned procedures above will be performed on enrollment and repeated at 18 months and 36 months, with the exception of monthly Alpha- net exacerbation questionnaires.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Emphysema
FEV1/FVC \<70%
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Understand the study procedures, risks, benefits, purpose
3. Able and willing to comply with the study procedures
4. Have PiMZ alpha-1 antitrypsin deficiency
5. Post bronchodilator FEV1 \< 80% predicted AND post bronchodilator FEV1/FVC \< 70%
6. Be an existing member of the Alpha-1 Foundation Clinical Cohort (also known as the Alpha-1 Foundation Research Registry)
7. Agree to have the data collected in this study be shared with the Alpha-1 Foundation Research Registry
Exclusion Criteria
2. Current lung, hematologic, or solid organ malignancy other than skin or cervical Stage 1 cancers within the past 3 years
3. COPD exacerbation or other pulmonary infection within 6 weeks of baseline visit
4. Pregnancy at the time of the screening visit
5. Inability to lie still in a supine position for 15 minutes during CT acquisition
6. Inability to perform quality-controlled lung function testing
7. Allergy to albuterol
8. Currently receiving intravenous or subcutaneous immunoglobulin for any disease state
9. Past or present major surgery on the lungs including pneumonectomy or lobectomy. Wedge resections, past segmentectomy, and pleurodesis surgeries are allowed.
10. Previous lung or liver transplantation or currently on the transplant list
11. Decompensated cirrhosis
12. Current presence of endobronchial coils or valves in the lung
13. 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.
14. 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.
15. Patient with Automatic Implantable Cardioverter Defibrillator (AICD) and permanent pacemakers (PPM)
16. Patient receiving biologic immunomodulators that will affect the assessment of the serum biomarkers (as determined by the site PI)
17. Patient with pleural catheters
18. Any condition that in the opinion of the investigator might adversely influence the study outcome
18 Years
ALL
No
Sponsors
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Alpha-1 Foundation
OTHER
Columbia University
OTHER
Responsible Party
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Principal Investigators
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Monica Goldklang, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California- Los Angeles
Los Angeles, California, United States
National Jewish Health
Denver, Colorado, United States
University of Chicago
Chicago, Illinois, United States
Columbia University Irving Medical Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AAAU9605
Identifier Type: -
Identifier Source: org_study_id
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