Not yet recruitingNAINTERVENTIONAL

SPutum Induction and Nebuliser deviCEs for Patients With CF

This study, called SPICE-CF, is for people with cystic fibrosis (CF) who find it hard to cough up sputum (phlegm) on their own. Researchers want to see if it's practical to recruit people for a study comparing two different nebuliser devices. These devices help people produce sputum for important tests. The study will also find out how acceptable and easy these sputum-producing procedures are for participants. It will compare a 'jet' nebuliser with an 'E-flow Rapid' nebuliser. Each person will try both devices to see which is better at collecting sputum and how they feel to use. This information will help plan bigger studies in the future.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Enrolment target

Start

01 Oct 2026

Estimated completion

01 Jul 2027

Cystic Fibrosis (CF)Cystic Fibrosis Lung Disease

What is this study about?

This study, called SPICE-CF, is for people with cystic fibrosis (CF) who have trouble producing sputum, also known as phlegm, on their own. Sputum samples are very important for checking for infections in the lungs and helping doctors decide on the best treatments. However, with newer CF medicines, many people with CF produce less sputum naturally, which can make these tests difficult.

Researchers want to find out the best way to help people with CF produce sputum when they can't do it easily. This study will compare two different types of devices, called nebulisers, that turn a salty solution into a fine mist for you to breathe in. This mist helps to loosen phlegm in the lungs so it can be coughed up and collected for testing. The main aim is to see if it's practical to run a study like this, and how well these two devices work.

The study will also look at how comfortable and easy the procedures are for participants, how long they take, and if enough sputum can be collected for testing using each device. The findings from this small study will be used to help plan bigger and more in-depth research in the future, aiming to improve how sputum samples are collected for people with CF.

Key takeaways

This study explores better ways to collect sputum samples from people with CF who struggle to produce them naturally.
It compares two different nebuliser devices for their effectiveness and user comfort.
Participation involves two clinic visits, where you'll use both devices.
Your lung function, oxygen, and heart rate will be monitored throughout.
The information helps plan future, larger studies to improve CF care.

Who may be eligible?

To join this study, you need to be at least 16 years old and have a confirmed diagnosis of cystic fibrosis. Researchers are looking for people who usually find it difficult to cough up sputum on their own.

However, there are some reasons why you might not be able to take part. This includes if you've had a bad reaction to salty solutions (hypertonic saline) in the past, or if your lung function is very low (less than 30% of what's expected). You also can't join if your oxygen levels are often low, or if you've had any recent bleeding from your lungs, a collapsed lung, or major chest or eye surgery.

Other reasons not to participate include if you've recently been treated for a lung infection, have certain heart conditions, are pregnant or trying to get pregnant, or are already taking part in another study that involves new medicines.

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.

I have been diagnosed with cystic fibrosis.
I am 16 years old or older.
I find it difficult to cough up sputum on my own.
I have not had a serious reaction to salty breathing solutions (hypertonic saline) before.
I haven't had recent lung bleeding, a collapsed lung, or major chest/eye surgery.
I am not pregnant or trying to conceive, and not in another medicine study.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit the study clinic twice. These visits will be at least two weeks apart. At each visit, you'll first be given a medicine (a bronchodilator) to help open your airways. Then, you'll use one of the two nebuliser devices (either the 'jet' or 'E-flow Rapid') to breathe in a salty solution. The order of which device you use first will be decided by chance, like flipping a coin.

During the procedure, a physiotherapist will help you with your usual airway clearance techniques to help you cough up sputum. Throughout this time, your lung function, oxygen levels, heart rate, and chest sounds will be carefully monitored. You'll be asked to provide any sputum you produce for testing. After each session, you'll fill out a short questionnaire about your experience and how you felt using the device. Each visit will take a few hours.

Potential risks and benefits

Taking part in this study may not directly improve your health, but the information gained could help other people with CF in the future by finding better ways to collect important lung samples. As with any medical procedure, there are some potential risks. Breathing in salty solutions can sometimes cause coughing or shortness of breath, but your medical team will monitor you closely and give you medication to help prevent this. Your heart rate and oxygen levels will also be checked regularly. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Royal Brompton Hospital
Verified postcode
London, United Kingdom

Common questions

What is sputum induction?

It's a way to help you cough up sputum (phlegm) for testing when you can't do it easily on your own, usually by breathing in a special salty mist.

Why is it important to collect sputum?

Collecting sputum helps doctors check for infections in your lungs, which is vital for planning the best treatment for your cystic fibrosis.

What are nebulisers?

Nebulisers are small machines that turn liquid medicine or solutions into a fine mist that you can breathe directly into your lungs.

Will I have to stay in hospital?

No, this study only involves two visits to a clinic, spaced at least two weeks apart. You won't need to stay overnight in hospital.

What if I feel uncomfortable during the study?

Your comfort and safety are a priority. Medical staff will be with you throughout the visits to monitor you and address any discomfort you might feel immediately.

How to find out more

Gemma Stanford, BSc (Hons), PhD

gemma.stanford2@nhs.net +44 20 7351 8071 Official trial record

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