A double-blind, randomized, placebo-controlled study to assess the safety and efficacy of nebulized PC945 when added to systemic antifungal therapy for the treatment of refractory invasive pulmonary aspergillosis (OPERA-T study)
This research is a 'Phase 3' study, meaning it's a key step to see if a new treatment works and is safe. It focuses on a serious lung infection called refractory invasive pulmonary aspergillosis, which means the infection hasn't responded well to standard treatments. Participants will either receive an investigational medicine called PC945 as a mist (nebuliser liquid) alongside their usual antifungal medicines, or a placebo mist (which looks and feels the same but contains no active medicine). The main goal is to find out how many people show a significant improvement in their condition within 12 weeks. We'll also be looking at how quickly people respond to treatment. This study includes adults aged 18 and over, both men and women.
At a glance
What is this study about?
This study is designed to help us understand if a new treatment can improve outcomes for people with a serious lung infection called refractory invasive pulmonary aspergillosis. 'Refractory' means that the infection has been hard to treat and hasn't gotten better with the usual antifungal medications.
The new treatment involves a medicine called PC945, which is given as a fine mist that you breathe in (called a nebuliser). The idea is to add this special mist treatment to the antifungal medicines you are already taking. Some participants will receive the actual PC945 mist, while others will receive a 'placebo' mist, which looks and feels exactly the same but doesn't contain any active medicine. This is a common way to test new treatments fairly.
The main thing we want to find out is how many people get significantly better within 12 weeks of starting the treatment. We'll also be tracking how quickly people respond and how long any improvements last. If successful, this new approach could offer a new way to help fight this difficult infection.
Key takeaways
- This study is testing a new mist treatment (nebulized PC945) for persistent lung infections.
- It's for people whose fungal lung infection hasn't responded to standard treatments.
- Participants will receive either the new medicine or a placebo alongside their usual care.
- The main goal is to see how many people improve significantly in 12 weeks.
- It's a 'Phase 3' study, a crucial step for potential new treatments.
- Participation involves regular medical checks and careful monitoring of your health.
Who may be eligible?
To join this study, you must be 18 years old or older – there's no upper age limit. Both men and women can take part. The most important requirement is that you have been diagnosed with refractory invasive pulmonary aspergillosis, meaning your lung infection hasn't improved with standard treatments.
There will also be other specific medical conditions and test results that the study doctors will check to make sure the study is right and safe for you. These might include details about your overall health, other medicines you are taking, and how well your body's organs are working.
It's important to discuss your full medical history with the study team. They will carefully review all your information to determine if you meet all the necessary criteria to be part of this research, ensuring your safety throughout the 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 been diagnosed with invasive pulmonary aspergillosis that hasn't responded to usual treatments?
- Are you able to attend regular study appointments?
- Are you willing to potentially receive either the new mist treatment or a placebo mist?
What does participation involve?
If you decide to participate, you will receive either the investigational medicine PC945 or a placebo, both given as a mist through a nebuliser, in addition to your current fungal infection treatments. This will happen over a period of 12 weeks. You will have regular appointments where the study team will monitor your health closely, perform physical exams, and take blood samples. They will also do imaging scans, like X-rays or CT scans, to check on your lung infection.
Beyond the initial 12 weeks, there will be follow-up appointments to see how you are doing in the longer term. Medication will be provided through the study. The total duration of the study participation, including follow-up, will be explained in detail by the study team. You'll be asked to keep a record of any symptoms you experience.
Potential risks and benefits
Locations (7)
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- —UnverifiedAustria
- —UnverifiedBelgium
- —UnverifiedItaly
- —UnverifiedGreece
- —UnverifiedFrance
- —UnverifiedGermany
Common questions
What is 'refractory invasive pulmonary aspergillosis'?
It's a serious lung infection caused by a common mould, where the infection hasn't responded well to usual treatments.
What does 'nebulized PC945' mean?
PC945 is the name of the new medicine, and 'nebulized' means it's given as a fine mist that you breathe in.
What is a 'placebo' in this study?
A placebo is a mist that looks and feels like the study drug but doesn't contain any active medicine. It helps us fairly compare the new treatment's effects.
How long will I be on the treatment?
The main treatment period is up to 12 weeks, but you'll have follow-up visits after this.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.
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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