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New study seeks better ways to track rare lung disease

NCT ID NCT05297812

Knowledge-focused Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 286 adults with Alpha-1 Antitrypsin Deficiency, a genetic condition that can damage the lungs and liver. Researchers use CT scans and blood tests over three years to see how lung density changes. The goal is to find biological markers that could help design better clinical trials for future treatments.

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 development of new treatments for Alpha-1 Antitrypsin Deficiency.
What could go wrong
This is an observational study, not testing a treatment. It may not find useful biomarkers, and results may not apply to all patients.

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

286 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Jan 2027

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 ZZ 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. Patients with known Alpha-1 Anti-trypsin deficiency (PiZZ) 3. Be an existing member of the Alpha-1 Foundation Clinical Cohort (Alpha-1 Foundation Research Registry) 4. Willingness to perform study procedures of Chest CT, blood biomarker determination, questionnaire completion, and lung function testing. Exclusion Criteria: 1. AATD non-PiZZ status, including carriers 2. Pregnancy at the time of the screening visit 3. COPD exacerbation or other pulmonary infection within 6 weeks of baseline visit 4. Previous lung or liver transplantation or currently on the transplant list

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Conditions

The condition(s) this trial relates to.

alpha 1-antitrypsin deficiency hereditary disease

As listed by the trial registrant

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

Alpha 1 antitrypsin deficiency Genetic disease

Contacts and locations

Locations

  • Boston University

    Boston, Massachusetts, 02118, United States

  • Columbia University

    New York, New York, 10032, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California - Los Angeles

    Los Angeles, California, 90095, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27514, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.