New study aims to find better ways to track lung disease in PiMZ patients

NCT ID NCT06505603

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Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 80 adults with PiMZ alpha-1 antitrypsin deficiency and mild-to-moderate COPD over three years. Researchers will use CT scans and blood tests to measure lung density changes and look for biomarkers that could be used in future treatment trials. No new treatment is being tested; the goal is to improve how disease progression is tracked in this group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could identify reliable biomarkers to speed up future drug trials for PiMZ patients with lung disease.
What could go wrong
This is an observational study with no treatment being tested. It may not lead to any direct benefit for participants or produce usable biomarkers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with Alpha-1 Antitrypsin Deficiency genotype MZ across the United States.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males and females aged 18 years and older 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: 1. AATD non-PiMZ status, including carriers 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Columbia University Irving Medical Center

    NOT_YET_RECRUITING

    New York, New York, 10032, United States

  • National Jewish Health

    NOT_YET_RECRUITING

    Denver, Colorado, 80206, United States

  • University of Alabama at Birmingham

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of California- Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Chicago

    NOT_YET_RECRUITING

    Chicago, Illinois, 60637, United States

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