A 2x2 factorial randomised open label trial to determine the CLinical and cost-Effectiveness of hypertonic saline (HTS 6%) and carbocisteine for Airway cleaRance versus usual care over 52 weeks in bronchiectasis
Bronchiectasis causes the lung airways to widen and gather thick mucus. This leads to daily coughing, breathlessness, and repeated chest infections that often require antibiotics or hospital care. While doctors sometimes prescribe mucus-thinning treatments, stronger evidence is needed to prove which ones work best. This trial tests two treatments: hypertonic saline (a strong salt water mist inhaled through a nebuliser) and carbocisteine (a capsule that thins phlegm). Participants are placed by chance into one of four groups to receive standard care alone, one of the medicines, or both together. Over one to two years, participants attend about six hospital visits and check their breathing at home once a week with a supplied hand-held device. The goal is to discover the best approach to keep lungs clearer, cut down flare-ups, and help people live more comfortably with bronchiectasis.
At a glance
What is this study about?
Bronchiectasis is a long-term lung condition where the airways become wider than normal. This shape change allows sticky phlegm to build up instead of clearing out naturally. When mucus gathers in the lungs, bacteria can easily grow, leading to regular chest flare-ups, repeated courses of antibiotics, and tiring coughing spells that interfere with everyday life.
Doctors frequently recommend airway clearance techniques and mucus-thinning medicines to help people cough up this phlegm. Two common options are hypertonic saline and carbocisteine. Hypertonic saline is a sterile, salty water liquid turned into a fine mist by a small machine called a nebuliser, which you breathe in for about ten minutes. Carbocisteine is a capsule swallowed with water that chemically loosens thick secretions. While both are already used within the NHS, medical teams do not yet have enough scientific proof to confirm if one works better than the other, or if combining both gives the best protection.
This study aims to fill that knowledge gap. By comparing people receiving these treatments alongside usual care against those receiving standard care alone over 52 weeks, researchers can measure which approach cuts down chest infections and hospital visits most effectively. The results will help shape future NHS treatment guidelines so that everyone with bronchiectasis receives the best possible care.
Key takeaways
- The trial compares salty water mist (hypertonic saline), carbocisteine capsules, or both against usual care for bronchiectasis.
- The main goal is to find out which treatment best clears mucus and prevents chest infections.
- Participation involves six hospital visits over two years and simple weekly breathing checks at home.
- You will continue to take your normal prescribed health medications throughout the study.
- Joining is entirely your choice, and you can withdraw at any point without altering your everyday NHS care.
Who may be eligible?
This trial is open to adults aged 18 and older who have a confirmed diagnosis of bronchiectasis from a chest CT scan, provided it is their main lung condition. To take part, you must cough up phlegm on most days and have experienced at least one chest flare-up in the past year that needed antibiotics. Your condition should also be stable, meaning you have not needed any treatment changes in the two weeks before joining.
You cannot take part if you have cystic fibrosis or if chronic obstructive pulmonary disease (COPD) is your primary lung problem. The study is also not suitable for current smokers or people with a heavy history of smoking.
Additionally, people who have active stomach ulcers, very low lung capacity, or who have regularly taken hypertonic saline or carbocisteine in the month before the study starts are unable to participate.
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 am aged 18 or older.
- I have been diagnosed with bronchiectasis via a chest CT scan.
- Bronchiectasis is my main lung condition (not cystic fibrosis or primary COPD).
- I cough up mucus or phlegm on most days.
- I have had at least one chest infection requiring antibiotics in the past 12 months.
- I do not currently smoke.
What does participation involve?
Taking part lasts up to two years (104 weeks), with the main treatment phase covering the first 52 weeks. You will be randomly assigned by a computer to one of four groups: standard care only, standard care plus hypertonic saline mist, standard care plus carbocisteine capsules, or standard care with both treatments.
You will attend around six hospital appointments across the two years, with five of those visits taking place in the first year. Each visit lasts roughly two hours. At these visits, the team will check your vital signs, perform simple breathing tests (spirometry), review your symptoms, and ask you to complete health questionnaires.
You will also be given a portable breathing monitor to use at home once a week and whenever you feel a chest infection starting. You will bring this device to your clinic visits so your study team can review how your lungs are doing over time.
Potential risks and benefits
Locations (23)
- Altnagelvin Area HospitalCity onlyLondonderry, Northern Ireland
- Royal Free HospitalApproximateLondon, England
- Royal Infirmary of EdinburghApproximateEdinburgh, Scotland
- Freeman HospitalApproximateNewcastle upon Tyne, England
- Royal Brompton HospitalApproximateLondon, England
- Belfast City HospitalUnverifiedBelfast, Northern Ireland
- Ninewells Hospital and Medical SchoolUnverifiedDundee, Scotland
- Princess Alexandra HospitalUnverifiedHarlow, England
- The Ulster HospitalUnverifiedDundonald, Northern Ireland
- Southampton General HospitalUnverifiedSouthampton, England
- Craigavon Area HospitalUnverifiedCraigavon, Northern Ireland
- University Hospitals of Morecambe Bay NHS Foundation TrustUnverifiedKendal, England
Common questions
Will I definitely receive one of the study treatments?
Not necessarily. A computer randomly assigns you to one of four groups. You have an equal chance of receiving hypertonic saline, carbocisteine, both treatments together, or continuing with your standard care alone.
How long does the nebuliser treatment take each day?
If you are placed in a group using hypertonic saline, inhaling the salty water mist through the nebuliser takes about ten minutes per session.
Can I carry on taking my normal chest medications?
Yes. You will be asked to continue taking your usual long-term prescribed medications as directed by your doctor, alongside any trial treatments you are given.
Do I have to pay for the study medicines or the home breathing device?
No. All study-related treatments, nebulisers, and home breathing monitors are provided free of charge for the duration of the trial.
What happens if I get a chest infection during the study?
You will treat your chest infection as you normally would, usually with antibiotics prescribed by your GP or specialist. You will also record the flare-up using your home monitor and report it to the study team.
How to find out more
Andrew Jackson
Always speak to your GP or specialist before deciding to take part in a study.
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