The CLEAR Trial
Research type
Research Study
Full title
A 2x2 factorial randomised examiner blind 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
IRAS ID
214254
Contact name
Stuart Elborn
Contact email
Sponsor organisation
Belfast Health and Social Care Trust
Eudract number
2017-000664-14
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
Title: A study to compare the effect of two medications (hypertonic saline and carbocisteine) with routine care to help clear sputum in people with bronchiectasis
Patients with bronchiectasis suffer from a persistent cough, daily sputum production and recurrent exacerbations. These can affect the quality of life of people living with bronchiectasis. This study is concerned with sputum production and exploring which combinations of agents (hypertonic saline (HTS) and carbocisteine) might help patients bring up their sputum more easily. These agents are currently used in clinical care but there is not enough evidence to recommend them as part of standard care.
HTS is salty water that is delivered into the airways via a nebuliser, which converts it into a mist. This treatment takes ten minutes. Carbocisteine is taken as a capsule. Research has shown these agents can make it easier for patients to cough up sputum resulting in potentially fewer exacerbations and hospital admissions which could improve quality of life for people with bronchiectasis.
Patients will be recruited to this study and randomly assigned to one of four groups; HTS and standard care, carbocisteine and standard care, a combination of HTS and carbocisteine with standard care and standard care alone. Participants will have to attend 6 additional appointments as part of the study over a 2-year period with 5 in year one.
This study is being funded by the NIHR and patients will be recruited from sites across the UK.
The study aims to find out whether HTS and/or carbocisteine can reduce the number of exacerbations suffered by people with bronchiectasis after 52 weeks of treatment. This research has the potential to impact guidelines for standard care in the future.
Alongside the trial there will be a SWAT about recruitment, and a sub-study looking in depth at exacerbations.
Lay summary of study results: Background:
Guidelines form expert groups and societies disagree on whether mucus-thinning drugs work for bronchiectasis, and doctors around the world don’t all use them the same way. To really know if these drugs are safe and help patients, we need large, carefully designed studies.
How the Study Was Done:
This study took place at 20 locations across the UK and involved people who have a lung condition called bronchiectasis (not caused by cystic fibrosis). These participants often had flare-ups and produced mucus daily. People who smoked or had recently used mucus-thinning treatments weren’t included.
Everyone in the study got regular medical care. In addition, they were randomly placed into one of four groups:
• One group got a salty water treatment (called hypertonic saline).
• Another got both the salty water and a drug called Carbocisteine.
• A third group got only Carbocisteine.
• The last group got no extra treatment beyond standard care.
The researchers wanted to compare how well hypertonic saline worked versus not using it, and how well Carbocisteine worked versus not using it. The main thing they measured was how many lung flare-ups each person had over a year. They also looked at quality of life, how long it took for the next flare-up to happen, and whether the treatments were safe.
Results
A total of 288 people took part in the study. They were randomly placed into different treatment groups. The researchers found no meaningful difference between the treatments. The drugs were safe and didn’t interact with each other in a way that changed the results.
Over the year, people who used hypertonic saline had an average of 0.76 flare-ups, while those who didn’t had 0.98. People who used Carbocisteine had 0.86 flare-ups, compared to 0.90 for those who didn’t.
“This means we would expect people who use hypertonic saline to have an average of 1 flare-up every 480 days, and those who don’t use it to have 1 flare-up every 372 days. “ “We would expect people who use Carbocisteine to have an average of 1 flare-up every 424 days, compared to 1 every 406 days for those who don’t use it. “ These very small differences were not significant enough to show that either treatment was beneficial to the patient.
When looking at other results — like quality of life and side effects — there were no major differences between the groups. This means that adding hypertonic saline or carbocisteine didn’t improve how people felt or reduce serious health problems compared to regular treatment.Conclusion:
In this study, people with bronchiectasis were treated with either hypertonic saline, carbocisteine, or just standard care. After one year, the results showed that neither of the two treatments helped reduce the number of chest flare-ups compared to standard care alone.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0339
Date of REC Opinion
30 Nov 2017
REC opinion
Further Information Favourable Opinion