ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)
This study, called ENCORE, is looking at a new inhaled medicine (Amikacin Liposome Inhalation Suspension, or ALIS) for adults newly diagnosed with a specific lung infection called Mycobacterium avium Complex (MAC). This infection is a type of Nontuberculous Mycobacterial (NTM) disease. Researchers want to find out if adding ALIS to the usual antibiotics helps patients more than the usual antibiotics alone. They will be checking if it improves breathing problems and successfully clears the infection. The study is a Phase III trial, which means it's a key step to see if this new treatment works well and is safe before it can be widely used. Participants will receive either the new inhaled medicine or a dummy medicine, alongside their regular MAC treatments.
At a glance
What is this study about?
This research study, named ENCORE, is designed for adults who have recently been diagnosed with a lung infection caused by a germ called Mycobacterium avium Complex (MAC). This is a type of infection that doesn't cause tuberculosis but can still be very serious, affecting the lungs.
The main goal of this study is to test a new inhaled medicine called Amikacin Liposome Inhalation Suspension, or ALIS. It's thought that ALIS, when used together with standard MAC treatments, might be more effective than standard treatments alone. The researchers want to see if this new medicine can help people breathe better and successfully clear the infection from their lungs.
This is a 'Phase III' study, which means it's a large and important step in testing new medicines. It compares the new treatment with existing ones to make sure it's both safe and works well. Your participation would help doctors understand better how to treat this challenging lung infection.
Key takeaways
- This study tests a new inhaled medicine (ALIS) for MAC lung infection.
- It aims to improve breathing symptoms and clear the infection.
- Participants will receive ALIS or a placebo, plus standard antibiotics.
- It's a long-term study lasting over a year.
- Participation involves regular clinic visits and health checks.
Who may be eligible?
To join this study, you must be an adult, aged 18 or older.
Crucially, you would need to have been recently diagnosed with a lung infection caused by Mycobacterium avium Complex (MAC). The study will have specific medical criteria to ensure it's the right fit for your health situation.
Detailed checks will be done by the study doctors to confirm you meet all the requirements and that it's safe for you to take part.
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 recently been diagnosed with a lung infection caused by Mycobacterium avium Complex (MAC)?
- Are you willing to take an inhaled study medicine and regular antibiotics?
- Can you commit to regular clinic visits for over a year?
What does participation involve?
If you join this study, it would involve regular visits to the clinic over a period of about 15 months. You would take either the new inhaled study medicine (ALIS) or a placebo (a dummy medicine that looks like ALIS but contains no active drug), delivered through a nebuliser. This will be given alongside your usual antibiotics for MAC infection. You won't know if you're getting the active medicine or the placebo, and neither will your study doctor, until the study is over. During your visits, doctors will measure your breathing symptoms, take samples to check the infection, and monitor your general health through physical exams and blood tests. There will also be follow-up appointments after your main treatment period to see how you are doing.
Potential risks and benefits
Locations (11)
- —UnverifiedDenmark
- —UnverifiedSpain
- —UnverifiedHungary
- —UnverifiedAustria
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedPoland
- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedPortugal
- —UnverifiedGreece
Common questions
What is MAC lung infection?
MAC lung infection is a type of lung disease caused by bacteria called Mycobacterium avium Complex. It's different from tuberculosis.
What is the new medicine being tested?
It's an inhaled medicine called Amikacin Liposome Inhalation Suspension (ALIS). It's given through a nebuliser, which turns the medicine into a fine mist you can breathe in.
How long does the study last?
The main part of the treatment and monitoring lasts for about 15 months, with some follow-up after that.
Will I know if I'm getting the real medicine or a placebo?
No, this is a 'blinded' study, meaning neither you nor your study doctor will know who gets the active medicine and who gets the placebo until the study is over.
What does a 'Phase III' study mean?
It means this is a large, important study to confirm if a new medicine is safe and effective before it can be considered for wider use.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.