A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
This study is looking into a new experimental medicine called LTI-03, which is breathed in using an inhaler. It's for people with Idiopathic Pulmonary Fibrosis (IPF), a serious lung condition that causes scarring and breathing difficulties. Researchers believe LTI-03 might help protect lung cells and reduce scarring. The main goals are to check if LTI-03 is safe, if it causes side effects, whether it can improve lung scarring, and if it makes IPF symptoms better. The study will compare LTI-03 to a dummy medicine (placebo) in people diagnosed with IPF in the last five years, including those already on common IPF treatments.
במבט חטוף
על מה המחקר הזה?
Idiopathic Pulmonary Fibrosis (IPF) is a lung condition where the lungs become scarred and stiff over time, making it harder to breathe. This scarring is progressive, meaning it tends to get worse. This study is testing a new experimental inhaled medicine called LTI-03. Researchers hope this medicine might help protect the parts of your lungs that take in oxygen and reduce the scarring, potentially making it easier to breathe.
The main purpose of this study is to find out if LTI-03 is safe for people with IPF and if it causes any unwanted side effects. It also aims to see if LTI-03 can help improve the scarring in the lungs and make IPF symptoms better. The study is particularly looking at people who have been diagnosed with IPF within the last five years. Importantly, you might still be able to take part even if you're already receiving other common IPF treatments, as long as your dose has been stable.
To ensure the results are clear, LTI-03 will be compared to a 'dummy' medicine called a placebo. A placebo looks exactly like the real medicine but contains no active ingredients. This helps researchers understand if any improvements are genuinely due to LTI-03 or other factors. The study will involve around 120 participants across different locations, and neither you nor the study team will know if you're receiving LTI-03 or the placebo.
נקודות עיקריות
- It's a study for adults with Idiopathic Pulmonary Fibrosis (IPF).
- It's testing an experimental inhaled medicine, LTI-03, against a placebo.
- The main goals are to check safety, side effects, lung scarring, and symptoms.
- Participation involves clinic visits, lung tests, and using an inhaler for 24 weeks.
- You might be eligible even if you're already on other IPF treatments.
- אתה יכול לפרוש מהמחקר בכל עת.
מי עשוי להיות זכאי?
This study is looking for men and women aged 40 or older who have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) in the last five years. Your lung scans need to show that at least 10% of your lung has fibrosis (scarring), and you must currently have certain levels of lung function.
If you are already taking medicines like nintedanib, pirfenidone, or nerandomilast for your IPF, you can still participate, but you must have been on a stable dose for at least 12 weeks before starting the study. If you stopped taking these medicines previously, you must have done so at least 8 weeks before the study begins. You also need to be able to use an inhaler properly.
However, you cannot take part if you have certain other lung conditions, are a smoker, have had a recent flare-up of your IPF, or have serious kidney problems. You also can't be taking certain other medications or participating in another clinical study.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- האם אתה בן 40 או יותר?
- Were you diagnosed with IPF in the last 5 years?
- Do your lung scans show at least 10% lung scarring (fibrosis)?
- Can you comfortably use an inhaler?
- Have you been on a stable dose of your current IPF medicine (if applicable) for at least 12 weeks?
- Are you a non-smoker and haven't had a recent IPF flare-up?
מה כרוך בהשתתפות?
If you decide to take part, you'll first have a screening period lasting about 4 weeks to check if you're suitable. Once confirmed, you'll be given either LTI-03 or a placebo, both delivered through a dry powder inhaler that you'll use yourself. This treatment period will last for 24 weeks.
During the study, you'll need to visit the study clinic up to 9 times. At these visits, doctors will monitor your health by checking your heart rate, blood pressure, and breathing, performing physical exams, and taking blood samples. You'll also have regular lung function tests to see how your lungs are working. On some visits, you'll fill out questionnaires about your symptoms, and you'll have special lung scans at the start and end of your treatment to check for changes in lung scarring.
After your 24-week treatment, there will be a final 4-week follow-up period. The total time you'd be involved in the study is about 29 weeks.
סיכונים ותועלות פוטנציאליים
מיקומים (48)
- UAB Lung Health Centerמיקוד מאומתבירמינגהם, ארצות הברית· גיוס
- University of Southern Californiaמיקוד מאומתלוס אנג'לס, ארצות הברית· גיוס
- מרכז רפואי סידרס סינימיקוד מאומתלוס אנג'לס, ארצות הברית· גיוס
- Paradigm Clinical Research Centers, LLCמיקוד מאומתסן דייגו, ארצות הברית· גיוס
- National Jewish Healthמיקוד מאומתדנוור, ארצות הברית· גיוס
- Yale University School of Medicineמיקוד מאומתניו הייבן, ארצות הברית· גיוס
- Cleveland Clinic Floridaמיקוד מאומתWeston, United States· גיוס
- אוניברסיטת אינדיאנהמיקוד מאומתאינדיאנפוליס, ארצות הברית· גיוס
- המרכז הרפואי של אוניברסיטת קנזסמיקוד מאומתקנזס סיטי, ארצות הברית· גיוס
- Henry Ford Healthמיקוד מאומתדטרויט, ארצות הברית· גיוס
- The Lung Research Center, LLCמיקוד מאומתChesterfield, United States· גיוס
- Icahn School of Medicine at Mount Sinaiמיקוד מאומתניו יורק, ארצות הברית· גיוס
שאלות נפוצות
What is Idiopathic Pulmonary Fibrosis (IPF)?
IPF is a lung disease that causes scarring and stiffness in your lungs, making it progressively harder to breathe.
What is LTI-03?
LTI-03 is a new, experimental medicine being tested for IPF. It's breathed into the lungs using an inhaler.
מהו פלצבו?
A placebo is a 'dummy' medicine that looks like the real treatment but has no active ingredients. It helps researchers understand the true effect of the new medicine.
Will I know if I'm getting the medicine or the placebo?
No, neither you nor the study team will know if you're receiving LTI-03 or the placebo. This is called a 'blinded' study.
Can I still take my usual IPF medication?
Yes, if you are on a stable dose of certain IPF medications, you may still be able to participate.
כיצד לגלות עוד
Steven A. Shoemaker, MD
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
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