Phase 2, proof-of-concept, randomized, double-blinded, placebo-controlled, multicenter study to assess efficacy and safety of reparixin as add-on therapy to standard of care in adult patients with Acute Respiratory Distress Syndrome (RESPIRATIO)
This research study is looking at a new tablet medicine, reparixin, for adults who have a severe lung condition called Acute Respiratory Distress Syndrome (ARDS). This condition makes it very hard to breathe. The study aims to find out if adding reparixin to the standard care patients already receive can help improve their breathing and recovery. We will compare reparixin to a dummy pill (placebo) to see if it makes a difference. Researchers will also be checking to see if the medicine is safe and doesn't cause too many side effects. This is an important step to see if reparixin could be a helpful treatment for people with ARDS in the future.
At a glance
What is this study about?
This study is looking into a new medication called reparixin for a serious lung condition known as Acute Respiratory Distress Syndrome, or ARDS. ARDS can happen when your lungs are badly injured, making it very difficult for your body to get enough oxygen. People with ARDS often need help breathing with a machine called a ventilator.
The main goal of this study is to see if adding reparixin to the usual care a patient receives can help their lungs get more oxygen. Researchers will track how well patients are breathing over the first week of treatment. They will also look at how many days patients can breathe on their own, without a ventilator, to see if the new medicine helps people recover faster. Safety is also a top priority, so doctors will carefully monitor all patients for any side effects.
By comparing reparixin to a dummy pill (placebo), doctors can truly understand if the new medicine is effective. This type of study is called 'double-blinded,' meaning neither the patient nor their doctor knows if they are receiving the actual medicine or the placebo. This helps ensure the results are fair and unbiased, so we can learn if reparixin could be a valuable treatment for ARDS in the future.
Key takeaways
- This study is testing a new medicine called reparixin for adults with serious lung problems (ARDS).
- It aims to see if reparixin, when added to usual care, helps improve breathing and recovery.
- Patients will receive either reparixin tablets or a dummy pill (placebo).
- Doctors will carefully monitor your breathing, oxygen levels, and overall health.
- The study also looks at how safe the new medicine is and any potential side effects.
- You can choose to leave the study at any time without affecting your medical care.
Who may be eligible?
This study is for adults who are at least 18 years old and have been diagnosed with Acute Respiratory Distress Syndrome (ARDS). This means your lungs are severely inflamed and struggling to get enough oxygen into your blood.
To join, participants will likely need to meet specific health criteria related to their ARDS, which a doctor will explain. There might be some medical conditions or other medicines you are taking that would mean you can't take part, as these could affect the study's results or your safety.
The research team will carefully review your medical history and current health to determine if this study is the right fit for you. Their main concern is always your safety and ensuring the study will provide clear answers.
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 Acute Respiratory Distress Syndrome (ARDS)?
- Are you currently receiving standard medical care for ARDS?
- Are you willing to take a study tablet (either reparixin or a placebo)?
- Are you able to attend regular health check-ups and provide blood samples?
What does participation involve?
If you decide to join this study, you will be given either the study medicine, reparixin, or an inactive dummy pill (placebo) to take by mouth. You will continue to receive the standard medical care for ARDS, with the study medicine being an 'add-on'. Throughout your time in the study, doctors and nurses will regularly check your breathing and overall health. This includes monitoring your oxygen levels and how many days you need help from a breathing machine. They will also take blood samples to check certain markers. You will have regular assessments both during your hospital stay and potentially for a follow-up period after discharge. The total duration of your participation in the study involves ongoing monitoring and assessments from when you start the treatment up to about 60 days.
Potential risks and benefits
Locations (2)
- —UnverifiedItaly
- —UnverifiedGermany
Common questions
What is ARDS?
ARDS (Acute Respiratory Distress Syndrome) is a severe lung condition where your lungs become very inflamed and struggle to get oxygen into your blood, making breathing difficult.
What is reparixin?
Reparixin is the new medication being tested in this study, taken as a tablet, to see if it can help improve lung function in people with ARDS.
Will I know if I'm getting the real medicine or a dummy pill?
No, neither you nor your doctor will know if you are receiving reparixin or a placebo during the study. This helps ensure fair results.
How long will I be involved in the study?
Your involvement will include monitoring and assessments from when you start the treatment up to about 60 days.
Can I leave the study at any time?
Yes, you are free to leave the study at any point without it affecting your ongoing 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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