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Can medical records reveal how fast lung function fades after transplant?

NCT ID NCT06503770

Knowledge-focused Sponsor: Zambon SpA Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This study reviews the medical records of about 284 adults who developed chronic lung allograft dysfunction with bronchiolitis obliterans syndrome (CLAD-BOS) after a lung transplant. Researchers will track how lung function, measured by FEV1, changes each year after diagnosis. They will also look at patient characteristics, other breathing test results, survival, hospitalizations, and other health conditions. The goal is to better understand the typical course of CLAD-BOS and identify patterns that might inform future care.

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
This study could help doctors better predict how quickly lung function declines in lung transplant patients with CLAD-BOS, potentially guiding earlier or more targeted care.
What could go wrong
Because this is a retrospective chart review, it only looks back at existing records and cannot prove what causes the decline. The findings may also be limited by incomplete or inconsistent medical data.

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

284 people

The number who actually took part.

Started

Jun 2024

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

The study population included adult patients (aged ≥ 18) years who were recipients of a lung transplant and diagnosed with CLAD-BOS from the first of 01 January 2013 following transplantation.

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. Adult patients ≥ 18 years of age on the date of CLAD-BOS diagnosis 2. Patients with a CLAD-BOS clinician diagnosis from as early as 01 January 2013 3. Patients with CLAD-BOS clinician diagnosis made at least 12 months after lung transplant 4. Patients received at least basic maintenance regimen of immunosuppressive agents including tacrolimus, a second agent such as but not limited to mycophenolate mofetil or azathioprine (or other anti-proliferative agent), and a systemic corticosteroid such as prednisone as third agent for at least 1 month before the index date. As long as the basic maintenance regimen is maintained for the abovementioned period, patients will still be considered eligible for the study even if they are receiving other immunosuppressive agents in addition to the basic maintenance regimen. Exclusion Criteria: 1. Patients with severe concomitant disease at the time of index date, which according to physician's judgment, can interfere with CLAD-BOS progression and mortality (e.g., malignancies, severe chronic diseases) 2. Patients who have been exposed to any investigational medical products in the 4 weeks prior to index date or during the post-diagnosis period 3. Patients with confirmed other CLAD phenotype (e.g., restrictive allograft syndrome) according to physician's judgment.

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Conditions

The condition(s) this trial relates to.

bronchiolitis obliterans syndrome transplant-related bronchiolitis obliterans

As listed by the trial registrant

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

Bronchiolitis obliterans syndrome

Contacts and locations

Locations

  • Baylor Scott and White Health Center for Advanced Heart and Lung Disease

    Dallas, Texas, 75246, United States

  • Cleveland Clinic Transplantation Center

    Cleveland, Ohio, 44195, United States

  • Hospital Universitario Marques de Valdecilla (HUMV)

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, 14004, Spain

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • Universitaire Ziekenhuizen Leuven (UZ Leuven)

    Leuven, Leuven, 3000, Belgium

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