An Open Label Follow-Up Study to Evaluate the Long Term Safety and Efficacy of L-CSA in Patients with a Diagnosis of CLAD-BOS after they have completed the participation to BOSTON 1 and BOSTON 2 studies
This research study is an ongoing look at a medication called Liposomal Ciclosporin A (L-CSA). It's focused on understanding how safe and effective this medicine is over a longer period for people who have had a lung transplant and are now experiencing Bronchiolitis Obliterans Syndrome (BOS). BOS is a serious condition that can affect how well new lungs work. The study is specifically for patients who have already taken part in two previous studies, BOSTON 1 and BOSTON 2, and are continuing their treatment. Researchers will be checking things like lung function, general health, and any side effects to see how L-CSA helps manage BOS and improve patients' lives in the long run. This is a "Phase III" study, which means it builds on earlier research to confirm results in more people.
At a glance
What is this study about?
This study is an ongoing part of research into a condition called Bronchiolitis Obliterans Syndrome (BOS). BOS can affect people who have had a lung transplant. It's a serious problem where the small airways in the new lungs get damaged and narrow, making it harder to breathe. This study is for patients who have been taking part in two earlier studies, BOSTON 1 and BOSTON 2, and are now continuing treatment with a specific medicine called Liposomal Ciclosporin A (L-CSA).
The main goal of this study is to continue monitoring how safe and helpful L-CSA is for these patients over a longer period. The medical team wants to see if L-CSA can help to slow down or stop the progression of BOS and improve or maintain lung function. They will carefully track various aspects of your health to understand the long-term effects of this treatment.
Researchers will be looking at several key things. This includes regular checks of your side effects, general health, blood and kidney tests, and physical examinations. They will also repeatedly measure your lung function using tests like FEV1 (how much air you can breathe out in one second) and FVC (the total amount of air you can breathe out). They want to see how these measurements change over time, how BOS affects your daily life (your quality of life), and if the medicine helps reduce the need for more medical care or re-transplantation. All of this information helps doctors understand better how to treat BOS effectively.
Key takeaways
- This study is for lung transplant patients with Bronchiolitis Obliterans Syndrome (BOS).
- It's a continuation for people who were in the BOSTON 1 or BOSTON 2 studies.
- The main goal is to look at the long-term safety and effectiveness of Liposomal Ciclosporin A (L-CSA).
- Researchers will monitor lung function, general health, and any side effects.
- Participation involves regular clinic visits for physical exams, blood tests, and lung function checks.
Who may be eligible?
To be considered for this study, you must have already taken part in either the BOSTON 1 or BOSTON 2 study.
You also need to be at least 18 years old. There is no upper age limit, meaning older adults can participate as long as they meet other criteria.
Both men and women are welcome to participate in this study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you had a lung transplant?
- Have you been diagnosed with Bronchiolitis Obliterans Syndrome (BOS)?
- Did you previously take part in either the BOSTON 1 or BOSTON 2 study?
What does participation involve?
If you continue in this study, you'll be regularly monitored to see how you're responding to the treatment and to keep an eye on your general health. This will involve regular visits to the clinic. During these visits, the medical team will carry out several assessments, including physical examinations, blood tests, and measurements of your lung function, such as how much air you can breathe out. They will also ask you about any side effects you might be experiencing. The study will continue as long as it's considered beneficial and safe for you, and until the overall study ends.
Potential risks and benefits
Locations (6)
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- —UnverifiedFrance
Common questions
What is Bronchiolitis Obliterans Syndrome (BOS)?
BOS is a serious condition that can affect people who have had a lung transplant. It causes the small airways in the new lungs to become damaged and narrow, making it difficult to breathe.
What is Liposomal Ciclosporin A (L-CSA)?
L-CSA is a specific type of medication that is being studied to see its long-term effects on managing BOS in lung transplant patients.
Why is this study continuing?
This study is continuing to gather more information on the long-term safety and effectiveness of L-CSA for people with BOS, especially after they've been in earlier studies.
Will I have to do new tests?
You will have regular checks, including physical exams, blood tests, and lung function tests, to monitor your health and how the treatment is working.
What is a 'Phase III' study?
Phase III means this study is an advanced stage of research. It aims to confirm the findings from earlier studies in a larger group of people and over a longer time.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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