A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
The ASPIRE study is looking into a new treatment called Buloxibutid for people with Idiopathic Pulmonary Fibrosis (IPF). IPF is a lung disease that makes it harder to breathe. This study will last 52 weeks and will compare Buloxibutid to a dummy pill, known as a placebo. Some people will take Buloxibutid alongside their usual IPF medicine, while others will take it alone if they can't take other treatments or have stopped them. Researchers will check if Buloxibutid is safe, how well it works, and how the body handles the medicine. The main goal is to see if it helps improve lung function, measured by how much air you can breathe out.
En un coup d'œil
De quoi parle cette étude ?
This study, called ASPIRE, is investigating a new oral medication called Buloxibutid for people with Idiopathic Pulmonary Fibrosis (IPF). IPF is a serious lung condition where the lungs become scarred and stiff, making it increasingly difficult to breathe. Current treatments for IPF aim to slow down the disease, but researchers are constantly looking for new and better options.
Buloxibutid works by targeting specific cells in the lungs that are thought to be important in IPF. Early studies have suggested it might help to improve lung function, protect lung cells, and reduce scarring. This trial aims to confirm these findings in a larger group of people over a longer period.
The study will involve 360 participants and run for 52 weeks. It's a 'double-blind' study, meaning neither you nor your doctor will know if you're taking Buloxibutid or a placebo (a dummy pill). This is done to make sure the results are as fair and unbiased as possible. The main way they'll measure if the treatment works is by checking your lung function, specifically how much air you can breathe out after taking a deep breath.
Points clés
- This study is testing a new oral drug called Buloxibutid for IPF.
- It lasts for 52 weeks and is comparing the drug to a dummy pill (placebo).
- It's a 'double-blind' study, meaning you won't know if you're getting the drug or placebo.
- The main goal is to see if Buloxibutid improves lung function.
- You might be able to join if you're not on IPF treatment or on some types of stable IPF treatment (but not pirfenidone).
- Vous pouvez arrêter de participer à tout moment.
Qui peut être éligible ?
To be considered for this study, you need to be at least 40 years old and have been diagnosed with IPF within the last seven years. Doctors will also check your recent lung scans to confirm your diagnosis and make sure your fibrosis (scarring) is more significant than any emphysema you might have.
Your current lung function will be checked using tests like FVC and DLCO, and these need to be above certain levels. You might be able to join if you're already taking an approved IPF treatment and have been on a stable dose for at least eight weeks. However, if you are currently taking pirfenidone, unfortunately, you won't be able to join this study due to potential interactions with the new drug.
Alternatively, you could also join if you're not currently on any licensed IPF treatment. This could be because you've had problems with other medications, they didn't work for you, your doctor advised against them, or you chose not to take them. You also need to be expected to live for at least another 12 months, and while being on a lung transplant list doesn't exclude you, your doctors will consider if you're likely to need a transplant during the study period.
Cet étude pourrait-elle vous convenir ?
Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.
- Are you at least 40 years old?
- Were you diagnosed with IPF in the last 7 years?
- Is your current lung function (FVC and DLCO) above 50% and 30% of what's expected, respectively?
- Are you NOT currently taking pirfenidone?
- Do you anticipate living for at least another 12 months?
- Could you commit to regular clinic visits for over a year?
En quoi consiste la participation ?
If you decide to take part, you'll first go through a screening period that could last up to six weeks to make sure you meet all the study requirements. If you qualify, you'll then be randomly assigned to one of three groups: one taking a higher dose of Buloxibutid, one taking a lower dose, or one taking a placebo (dummy pill). You'll take your study medication twice a day for 52 weeks.
Throughout the study, you'll have regular visits to the clinic for various checks. These will include measurements of your lung function, blood tests, and other health assessments to monitor your safety and how well the treatment is working. Neither you nor your study doctor will know which treatment you are receiving until the study is over. After the 52-week treatment period, there will be a follow-up period of 2-4 weeks to ensure your well-being.
Risques et avantages potentiels
Locations (104)
- UAB Hospital, School of Medicine/Lung Health CenterCode postal vérifiéBirmingham, États-Unis
- Paradigm Clinical Research Centers, Inc.Code postal vérifiéRedding, États-Unis
- UC Davis Health SystemCode postal vérifiéSacramento, États-Unis
- UC San Diego Medical Center - HillcrestCode postal vérifiéSan Diego, États-Unis
- Paradigm Clinical ResearchCode postal vérifiéSan Diego, États-Unis
- National Jewish Medical and Research CenterCode postal vérifiéDenver, United States
- University of Florida Health (UF Health)Code postal vérifiéGainesville, États-Unis
- Clinical Research SpecialistsCode postal vérifiéKissimmee, United States
- Emory Saint Joseph's HospitalCode postal vérifiéAtlanta, États-Unis
- Endeavor Health - Evanston HospitalCode postal vérifiéEvanston, United States
- University of Kansas Medical CenterCode postal vérifiéKansas City, États-Unis
- William Beaumont Hospital - Royal OakCode postal vérifiéRoyal Oak, United States
Questions fréquentes
What is Idiopathic Pulmonary Fibrosis (IPF)?
IPF is a lung disease where the lungs become scarred and stiff, making it hard to breathe. The cause isn't fully known, which is why it's called 'idiopathic'.
What is Buloxibutid?
Buloxibutid is an experimental medication being tested to see if it can help improve lung function and slow down the progression of IPF.
What does 'double-blind, placebo-controlled' mean?
It means neither you nor your doctor will know if you're getting the active drug or a dummy pill (placebo). This helps make the study results more reliable.
Combien de temps vais-je participer à l'étude ?
The treatment phase of the study lasts for 52 weeks, with an initial screening period of up to 6 weeks and a follow-up period of 2-4 weeks afterwards.
Can I take part if I'm already on IPF medication?
Yes, potentially, as long as you've been on a stable dose for at least 8 weeks. However, if you're taking pirfenidone, you won't be able to join this particular study.
Comment en savoir plus
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
Discussion
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