Phase 2 COPD Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Cohort A (diagnosed with Bronchiolitis Obliterans Syndrome, or BOS, after a stem cell/bone marrow transplant):

• A person must have a confirmed diagnosis of BOS after a blood stem cell transplant, based on specific breathing test results that meet either the standard or "atypical" diagnostic criteria (confirm with trial site for which set of criteria applies)
• Breathing test results must show a certain pattern of airflow obstruction — specifically, a low ratio of two breathing measurements (FEV1/VC below 0.7 or below the 5th percentile), AND lung function (FEV1) below 75% of the expected value with a drop of at least 10% over less than 2 years, AND this low result must not improve significantly with a reliever inhaler
• There must be no active lung infection at the time of joining, confirmed through tests such as chest X-rays, CT scans, or laboratory cultures
• At least one additional sign of BOS must be present — either air trapping or airway changes seen on a chest CT scan, OR air trapping shown on breathing tests

Cohort A – Atypical criteria (an alternative set of criteria for BOS diagnosis):

• Lung function (FEV1) below 80% of the expected value with a drop of at least 10% over the past 2 years or since transplant
• Another breathing measure (VC) below 80% of the expected value
• The FEV1/VC ratio must be above 0.7
• No active lung infection or other active non-infectious lung condition that could explain the breathing test changes

Cohort B (early-stage BOS, called BOS-0p):

• A drop in a specific breathing measurement (FEV1) of between 10% and 19% compared to pre-transplant testing, OR a drop of more than 25% in another breathing measure (FEF25-75%) compared to pre-transplant testing

All participants (Cohorts A and B):

• Adults aged 18 or older
• A general health status that falls within an acceptable range on a standard medical scale (confirm with trial site)
• Blood test results showing the bone marrow and organs such as the liver are functioning at an acceptable level (specific thresholds apply — confirm with trial site)
• No sign of the original cancer having returned at the time of joining
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting the study drug
• The ability to understand the study and willingness to sign a consent form

Who may not be able to join:

• People who have already received treatment specifically aimed at BOS (treatment for a related condition called chronic graft-versus-host disease, or cGVHD, without BOS is acceptable)
• People who have previously taken the study drug, belumosudil
• People who are currently taking another experimental immune-suppressing treatment for cGVHD
• People with an active, uncontrolled infection — defined as being seriously unwell from infection, or having new or worsening symptoms, physical signs, or scan findings linked to an infection (a persistent fever alone, without other signs, is not automatically considered an uncontrolled infection)
• People known to have HIV infection
• People with active hepatitis B or hepatitis C infection that requires treatment, or people considered at risk of hepatitis B reactivating — this includes people who test positive for certain hepatitis B markers (confirm with trial site for specific testing requirements)

Important: Always verify eligibility with the trial site directly before applying.