Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

Phase 1/2a Trial to Evaluate the Safety, Tolerability and Efficacy of Nebulised RESP30X Nitric Oxide Formulations in Non-Cystic Fibrosis Bronchiectasis (NCFB) Patients with Pseudomonas Aeruginosa (Pa) or other Potentially Pathogenic Micro-organisms (PPMs).

This research study is looking at a new inhaled treatment called RESP30X. It's designed for adults who have a lung condition called non-cystic fibrosis bronchiectasis (NCFB), especially if they also have lung infections caused by bacteria like *Pseudomonas aeruginosa* or other harmful germs. We're in an early stage of testing (Phase 1/2a), which means we're mainly focused on understanding if the medicine is safe and how well people can tolerate it. We're also checking how the body handles the medicine and if it shows any signs of working. The study compares RESP30X, a similar version called RESP303, and a common lung medicine called Salbutamol, all given through a nebuliser.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Thirty Respiratory Limited

Enrolment target

Start

18 Apr 2024

Non-Cystic Fibrosis Bronchiectasis with Pseudomonas Aeruginosa or other Potentially Pathogenic Micro-organisms

What is this study about?

This research study is about finding new ways to help people living with non-cystic fibrosis bronchiectasis (NCFB). This is a long-term lung condition where the airways become wider and scarred, making it harder to clear mucus and leading to infections. These infections, especially from bacteria like *Pseudomonas aeruginosa*, can make the condition worse and cause frequent flare-ups.

The new medicine being tested is called RESP30X (and a similar version, RESP303). It's given as an inhaled mist using a nebuliser, which is a common way to deliver medicines directly to the lungs. The idea behind RESP30X is to use nitric oxide, a natural gas that our bodies already produce, to help fight these stubborn lung infections. We'll also be comparing it to Salbutamol, another medicine often used by people with breathing difficulties, also given via nebuliser.

Because this is an early-stage study (called Phase 1/2a), our main goal is to make sure the new medicines are safe. We'll be carefully watching for any side effects and how well people tolerate the treatment. We'll also take measurements like blood pressure, heart rate, and do blood tests to see how the new medicines affect the body. We'll also look at how much of the medicine gets into the bloodstream and how long it stays there.

Key takeaways

This study tests a new inhaled medicine (RESP30X) for non-cystic fibrosis bronchiectasis.
It aims to see if the medicine is safe, well-tolerated, and effective against lung infections.
Participation involves breathing in medicine via a nebuliser and regular health check-ups.
You must be an adult (18+) with NCFB and certain lung infections to be considered.
The study is in an early stage, focusing on safety and how the body reacts to the medicine.

Who may be eligible?

This study is looking for adults aged 18 and older.

You might be able to join if you have non-cystic fibrosis bronchiectasis and have also had lung infections caused by certain bacteria, such as *Pseudomonas aeruginosa* or other potentially harmful germs.

There will also be other specific health requirements that your doctor will check to make sure the study is a good fit for you and safe for your health.

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 non-cystic fibrosis bronchiectasis?
Have you had lung infections caused by bacteria like *Pseudomonas aeruginosa* or other specific germs?
Are you able to attend regular clinic visits for assessments and treatments?
Are you able to use a nebuliser to inhale medicine?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive one of the medicines (RESP30X, RESP303, or Salbutamol) through a nebuliser. This means you would breathe in a fine mist of the medicine for a set period of time. You would have several visits to the clinic where study staff will check your health. This includes taking your blood pressure, heart rate, temperature, and checking your oxygen levels. You would also have blood tests and regularly report any effects you experience.

The study will involve a number of visits over a certain period, and you would be carefully monitored throughout. More details about the exact number of visits, their duration, and the total length of your participation would be fully explained by the study team.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as access to a new treatment that isn't widely available. While we hope the new medicine will be helpful, it's also possible that it may not improve your condition. There are always potential risks with any new medicine, including side effects. These will be carefully monitored, and the study team will explain all known or expected risks to you. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Romania
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Unverified
Bulgaria
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Unverified
Poland

Common questions

What is non-cystic fibrosis bronchiectasis (NCFB)?

NCFB is a long-term lung condition where the airways become wider and scarred, making it harder to clear mucus and making you prone to infections.

What is a nebuliser?

A nebuliser is a device that turns liquid medicine into a fine mist, which you then breathe in directly into your lungs.

What does 'Phase 1/2a' mean for a study?

It means this is an early study primarily focused on checking if the new medicine is safe and how well people tolerate it, as well as looking for early signs it might be working.

What are 'potentially pathogenic micro-organisms'?

These are types of germs, like bacteria (e.g., *Pseudomonas aeruginosa*), that can cause infections or make existing lung conditions worse.

Will I know which medicine I'm getting?

Often in studies like this, you won't know which treatment you are receiving (this is called 'blinding') to ensure fair results. The study team will explain the details.