Study on the Effectiveness of Belumosudil and Azithromycin for Adults with Chronic Lung Rejection After Lung Transplant

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What is this study about?

This clinical trial is focused on studying a condition known as chronic lung allograft dysfunction (CLAD), which can occur after a person has received a lung transplant. The study is testing a treatment called belumosudil, which is taken as a tablet. The purpose of the study is to evaluate how effective belumosudil is in improving lung function in adults who have developed CLAD after a lung transplant. Participants in the study will be randomly assigned to receive either belumosudil or a placebo, which is a tablet that looks like the treatment but does not contain the active medicine.

During the study, participants will take the tablets by mouth. The study will be conducted in two parts: an initial phase where participants will not know if they are receiving belumosudil or the placebo, followed by an open-label phase where all participants will receive belumosudil. The study will last for several months, and participants will have regular check-ups to monitor their lung function and overall health. Lung function will be measured using a test called forced expiratory volume in 1 second (FEV1), which assesses how much air a person can exhale in one second.

Participants in the study will have already been treated with another medication called azithromycin for at least eight weeks before starting the trial. The study aims to see if belumosudil can help improve lung function and slow down the progression of CLAD. Throughout the study, researchers will also monitor for any side effects or adverse events to ensure the safety of the participants. The results of this study could provide valuable information about the potential benefits of belumosudil for people with CLAD following a lung transplant.

1 joining the study

Participation begins after meeting specific criteria, including being at least one year post bilateral lung transplantation and having chronic lung allograft dysfunction (CLAD) Stage 1 or 2.

Participants must have been on azithromycin treatment for at least 8 weeks prior to joining the study.

2 randomization and initial treatment

Participants are randomly assigned to receive either the study medication, belumosudil, or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication.

The medication is administered orally in the form of film-coated tablets.

3 treatment period

The primary treatment period lasts for 26 weeks. During this time, lung function is monitored through tests measuring forced expiratory volume in 1 second (FEV1).

Participants continue to take the assigned medication as directed throughout this period.

4 evaluation of primary outcomes

The main goal is to assess the percent change in FEV1 from the start of the study to Week 26.

Additional evaluations include the response rate, defined as the proportion of participants with a decline in FEV1 of 10% or less at Week 26 compared to baseline.

5 evaluation of secondary outcomes

Secondary outcomes include changes in lung function, exercise capacity, and quality of life measures.

Participants’ health and any adverse events are monitored throughout the study.

6 open-label extension

After the initial 26-week period, participants may enter an open-label extension phase where all receive the study medication, belumosudil.

This phase allows for continued monitoring of lung function and overall health.

Who Can Join the Study?

  • The participant must be at least 1 year past a bilateral lung transplantation at the time of screening. This means they have received two new lungs.
  • The participant must have CLAD Stage 1 or 2. CLAD stands for Chronic Lung Allograft Dysfunction, which is a condition affecting the lungs after a transplant. Stage 1 or 2 means the condition is in its early stages.
  • The participant’s FEV1 (Forced Expiratory Volume in 1 second) should be between more than 50% and 80% of their best lung function after the transplant, both at the time of screening and when they are randomly assigned to a group in the study. FEV1 is a measure of how much air a person can forcefully exhale in one second.
  • The participant must have taken azithromycin for at least 8 weeks before being randomly assigned to a group in the study. Azithromycin is a type of antibiotic, and they should have taken at least 250 mg per day, at least 3 times a week, after being diagnosed with CLAD.
  • Both male and female participants are eligible to join the study.
  • The study includes participants from vulnerable populations, which means it considers people who might need extra care or protection.

Who Cannot Join the Study?

  • Patients who have not undergone a bilateral lung transplantation. This means both lungs have been transplanted.
  • Patients who do not have Stage 1 or 2 CLAD. CLAD stands for Chronic Lung Allograft Dysfunction, which is a condition affecting the lungs after a transplant.
  • Patients who are not experiencing lung transplant rejection. This is when the body’s immune system attacks the transplanted lung.
  • Patients who are not within the specified age range. The study is for certain age groups only.
  • Patients who are not part of the specified clinical trial groups. This refers to specific categories or groups of patients that the study is focusing on.
  • Patients who are not considered part of a vulnerable population. This term refers to groups of people who might be at higher risk or need special protection in research.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria
Katholieke Universiteit te Leuven Leuven Belgium
Oslo Universitetssykehus HF Oslo Norway
Hospital Universitario Y Politecnico La Fe Valencia Spain

Other Sites

Site Name City Country Status
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
University Hospital Olomouc Olomouc Czechia
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. Palermo Italy
Azienda Ospedaliera di Padova Padua Italy
Slaskie Centrum Chorob Serca W Zabrzu Zabrze Poland
Assistance Publique Hopitaux De Paris Paris France
Rigshospitalet Copenhagen Denmark
Hospital Foch Suresnes France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Centre Hospitalier Universitaire De Nantes Saint-Herblain France
Semmelweis University Budapest Hungary
Sgyptkepqgt Pfgtecbpj Wihhsawvut Skcdryy Zuiwozfnv W Sxjnzmsupg Szczecin Poland
Fwzqojwf nplcmstue Mviru a Hvgmusy Prague Czechia
Aoiuduydcx Pauuxkgh Hcwgqzxm Dr Mmdakwzjo Marseille France
Hjyfqfgh Uqayqghirx Cyxdcea Hthhkxys Helsinki Finland
Aejznbs Omfzebfmpaa Uxrjiazhvflzn Sdnyql Siena Italy
Kfzzclwl dku Uudosbeuzdrf Magbmqsg And Munich Germany
Gjdzuu Havzbzkuxra Udlfoxzlmoozo Pspxb Pyjnbctymjb Ep Najrqhgpoftb Paris France
Unpttgqdzuhj Mqeutbl Ckeabwq Gnuhhvvsx Groningen The Netherlands
Hcnwqoqm Ujfrwyyezqyjp Mhnylzb Dz Vafzysbnvx Santander Spain
Hmoqqkwl Vuvh dsszmmsd Barcelona Spain
Hotkouax Umtzyxxicieuk dz A Cibvkk A Coruna Galicia Spain
Hdhfvuhe Uyvuygnigokvvm Sbnmcadimz &pnoxua Hjsjnrk dy Hojuofzwlne STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
09.10.2023
Belgium Belgium
Recruiting
09.10.2023
Czechia Czechia
Recruiting
09.10.2023
Denmark Denmark
Recruiting
09.10.2023
Finland Finland
Recruiting
09.10.2023
France France
Recruiting
09.10.2023
Germany Germany
Recruiting
09.10.2023
Hungary Hungary
Recruiting
09.10.2023
Italy Italy
Recruiting
09.10.2023
Norway Norway
Not recruiting
09.10.2023
Poland Poland
Not recruiting
09.10.2023
Spain Spain
Recruiting
09.10.2023
Sweden Sweden
Not yet recruiting
09.10.2023
The Netherlands The Netherlands
Recruiting
09.10.2023

Trial locations

Belumosudil is an oral medication being studied for its potential to improve lung function in adults who have chronic lung allograft dysfunction (CLAD) after receiving a bilateral lung transplant. The trial aims to see if belumosudil can help maintain or improve the ability to breathe by measuring the forced expiratory volume in one second (FEV1), which is a common test to assess lung function.

Investigated diseases:

Lung transplant rejection – This condition occurs when the body’s immune system attacks the transplanted lung, viewing it as a foreign object. It can happen at any time after the transplant, but is most common in the first year. The rejection process can lead to inflammation and damage to the lung tissue, affecting its function. Symptoms may include shortness of breath, cough, and a decrease in lung function. Over time, if not managed, it can lead to chronic lung allograft dysfunction, which further impairs lung function. Monitoring and managing this condition is crucial to maintaining the health of the transplanted lung.

Trial ID:
2023-503462-23-00
Protocol code:
EFC17801
NCT ID:
NCT06082037
Trial Phase:
Therapeutic confirmatory (Phase III)

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