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:

• People who are over 18 years old
• People who received a double lung transplant at least 12 months before joining the study
• People who have been diagnosed with a specific type of chronic lung transplant complication called CLAD-BOS, where breathing test results (measuring airflow) have dropped to between 51–85% of their personal baseline, this drop has lasted more than 30 days, and the diagnosis was made within the past 12 months
• People who are currently taking a stable combination of three standard anti-rejection medicines (prednisone, plus either mycophenolate or azathioprine, plus either tacrolimus or cyclosporine), with doses unchanged for at least 4 weeks before screening
• People who have not taken sirolimus or everolimus for at least 4 weeks before screening
• People who are well enough to undergo routine post-transplant lung procedures (bronchoscopy with fluid sampling and tissue biopsy if needed)
• People who are able to understand the study's purpose and risks, and can follow the study requirements
• People who have provided written consent to participate
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before joining the study
• Women who could become pregnant and are sexually active must agree to use highly effective contraception during the study and for 90 days after the last dose of study treatment
• Women who could become pregnant must agree not to breastfeed or donate eggs during the study and for 90 days after the last dose of study treatment
• Male participants must agree to use a condom during sexual contact with a woman who could become pregnant, throughout the study and for 90 days after the last dose of study treatment
• Male participants must agree not to donate sperm during the study and for 90 days after the last dose of study treatment

Who may not be able to join:

• People who are pregnant, breastfeeding, or unwilling to use birth control during the study
• People with any condition that, in the treating doctor's judgement, could affect their safety or the quality of the study data
• People who have had a second lung transplant or who are currently on a waiting list for one
• People whose lung function decline has another confirmed cause, such as active infection, acute rejection, or a different type of transplant complication (called CLAD-RAS)
• People who have active antibody-mediated rejection at the screening visit (note: people who are clinically stable but have detectable donor-specific antibodies may still be considered eligible — confirm with trial site)
• People with an active bacterial, viral, or fungal infection that has not fully resolved at least 4 weeks before the screening visit (people with stable chronic infections may still be considered eligible — confirm with trial site)
• People who have been on a mechanical ventilator within the 12 weeks before joining the study
• People whose blood oxygen level at rest on normal room air is below 89%, or who need supplemental oxygen while at rest
• People who have developed a significant airway narrowing or structural airway problem after their BOS diagnosis, which is still present at screening
• People with a known allergy to sirolimus or everolimus
• People who are currently enrolled in another clinical trial for the same type of lung transplant complication (obstructive CLAD/BOS)
• People with serious kidney disease, defined as having a creatinine level above 2.5 mg/dL at screening, or who require dialysis
• People with liver disease where certain liver markers in blood tests are significantly above the normal range
• People who have had an active cancer in the past 2 years, including a transplant-related blood cancer, except for certain treated localised skin cancers
• People with any cancer history that is likely to cause significant health problems or require major treatment within the next 6 months (minor procedures for localised skin cancer are generally excluded from this — confirm with trial site)
• People with a known severe allergic reaction to lactose (people with lactose intolerance without severe allergy may still be eligible — confirm with trial site)
• People with uncontrolled high blood pressure

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