RecruitingNAINTERVENTIONAL

Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis

This study is investigating a new device called SIMEOX for people in the UK with non-cystic fibrosis bronchiectasis. This lung condition causes a build-up of mucus, leading to infections. SIMEOX is designed to clear mucus using gentle air pulses, and it can be used at home. The study aims to find out if using SIMEOX, alongside remote physiotherapy, can improve patients' quality of life and reduce the number of lung infections they experience over a long period. Researchers will compare this approach to standard care, which also includes remote physiotherapy. They are particularly interested in seeing how helpful the device is for long-term use.

At a glance

Status

Recruiting

Phase

Sponsor

Physio-Assist

Enrolment target

622

Start

03 Feb 2025

Estimated completion

01 Dec 2027

Non-cystic Fibrosis Bronchiectasis

What is this study about?

This study is about a lung condition called non-cystic fibrosis bronchiectasis. In this condition, the airways in your lungs become wider than they should be, making it hard to clear mucus. This sticky mucus can lead to infections and ongoing inflammation. Regular physiotherapy is very important for people with bronchiectasis to help clear their airways.

However, getting to physiotherapy appointments can be difficult due to travel, time, or simply not enough trained professionals. This study is looking at an innovative device called SIMEOX, which you can use at home. It works by sending gentle, short pulses of air into your airways. This helps to loosen the mucus and make it easier to cough up and remove. Early studies have shown that people using SIMEOX at home alongside remote physiotherapy felt much better and were happy with how it helped clear their lungs.

The main goal of this study is to see if using SIMEOX at home for a long time improves the quality of life for people with bronchiectasis and reduces the number of serious lung infections they experience. Researchers will compare this new approach to what is considered standard care, which in this study will also include remote physiotherapy. They want to understand if this home-based treatment can make a real difference in managing the condition.

Key takeaways

This study explores a home-use device (SIMEOX) for lung mucus clearance.
It's for adults with non-cystic fibrosis bronchiectasis.
The goal is to improve quality of life and reduce lung infections.
Participants will also receive remote physiotherapy support.
Compares SIMEOX with standard care over a long period.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To be part of this study, you need to be an adult (18 years or older) and primarily have non-cystic fibrosis bronchiectasis that a CT scan has confirmed. You should regularly produce mucus and be feeling stable at the time you join the study – meaning you haven't had a recent flare-up or change in your main treatments.

Also, you must have experienced at least two lung infections needing treatment changes in the past year, or one infection that required a hospital stay. The study team will also need to believe you can comfortably use the device and follow the study instructions. You cannot be using certain other mechanical airway clearance devices at home, nor have cystic fibrosis, severe COPD, or uncontrolled asthma.

There are a few other reasons you might not be able to join, such as if you smoke, have certain immune problems, or unstable heart conditions. The study team will discuss all these points with you to make sure it's safe and suitable 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?
Do you have non-cystic fibrosis bronchiectasis?
Do you regularly produce mucus?
Have you had at least two lung infections in the last year, or one needing hospitalisation?
Are you currently feeling stable and not experiencing a lung flare-up?
Are you not using certain other airway clearance devices at home?

Answer every question to see your result.

What does participation involve?

If you join this study, you will either use the SIMEOX device at home or continue with standard care, both of which will include remote physiotherapy sessions roughly every two weeks. You'll have regular check-ups, which might involve questionnaires about your quality of life and lung health. The study will likely involve using the device or following your assigned care plan for a significant period to see long-term effects. The total duration of the study will be discussed with you.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might find that participating improves your quality of life or helps manage your lung condition better. However, there's no guarantee the treatment will work for everyone, and you might not experience any direct benefit yourself. Some people might find using the device or attending appointments takes extra time. As with any medical device, there's a small chance of side effects, which the study team will explain fully. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (57)

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

CH Abbeville
Verified postcode
Abbeville, France· Recruiting
CH Aix en Provence
Verified postcode
Aix-en-Provence, France· Recruiting
CH Albi
Verified postcode
Albi, France· Recruiting
Clinique Victor Pauchet
Verified postcode
Amiens, France· Recruiting
CHU Amiens Picardie
Verified postcode
Amiens, France· Recruiting
CHU Angers
Verified postcode
Angers, France· Recruiting
CH Annecy
Verified postcode
Annecy, France· Recruiting
Clinique Aressy
Verified postcode
Aressy, France· Not yet recruiting
CHRU Brest
Verified postcode
Brest, France· Recruiting
CH Cotentin
Verified postcode
Cherbourg, France· Recruiting
CH Compiègne-Noyon
Verified postcode
Compiègne, France· Recruiting
CH Alpes-Léman
Verified postcode
Contamine-sur-Arve, France· Recruiting

Common questions

What is non-cystic fibrosis bronchiectasis?

It's a long-term lung condition where your airways become permanently wider, making it harder to clear mucus, which can lead to infections.

What is the SIMEOX device?

It's a home-use device that uses gentle air pulses to help loosen and clear mucus from your lungs.

Will I still get physiotherapy?

Yes, both groups in the study will receive remote physiotherapy sessions, which means you'll have guidance from a therapist from a distance.

What will researchers be looking for?

They want to see if using SIMEOX improves your quality of life and reduces the number of lung infections you get over time.

Can I stop participating if I want to?

Yes, you are free to withdraw from the study at any time without it affecting your medical care.

How to find out more

Pauline Périnet-Marquet

p.perinet-marquet@icadom.com +33 7 63 23 66 15 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.