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.
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