Randomised Open Label Trial of Hypertonic Saline and Carbocisteine in Bronchiectasis (CLEAR)
NCT ID: NCT04140214
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
288 participants
INTERVENTIONAL
2018-06-27
2024-12-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Bronchiectasis
NCT01112410
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled CHF6333 After Single Doses in Healthy Volunteers and After Single and Repeated Doses in Subjects With Bronchiectasis
NCT06166056
A Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Inhaled H057 in the Treatment of Acute Exacerbations of Bronchiectasis
NCT06958861
Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy
NCT05868941
Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial
NCT03846570
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The current guidelines indicate that mucoactives in combination with airway clearance may be considered to enhance sputum expectoration in BE, but the evidence to support their use is limited. Furthermore, evidence for the effectiveness of hypertonic saline (HTS) and carbocisteine is insufficient to recommend them within the management of BE. However, EMBARC/BRONCH-UK data show that BE centres do prescribe mucoactives. This is important because adherence to therapies in BE in general is low, decreases as the number of prescribed medications increases, and is also related to poorer patient outcomes, including the number of pulmonary exacerbations and quality of life. Therefore, it is essential that only those drugs that are effective should be prescribed for patients with BE. There are cost considerations associated with mucoactives, and there is a risk of polypharmacy side effects.
Unlike BE, relatively strong evidence exists to favour the use of both HTS and carbocisteine within other respiratory conditions. Therefore, this trial will answer important clinical questions about whether similar benefits can be demonstrated in BE by using a pragmatic design to explore the specific effects of mucoactive agents, and directly support, or refute, more targeted use of these drugs.
Patients will be randomised to one of four treatment groups: (i) standard care and twice daily nebulised HTS (6%), (ii) standard care and carbocisteine, (iii) standard care and combination of twice-daily nebulised HTS and carbocisteine, or (iv) standard care alone.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard Care and HTS
Standard care and twice-daily nebulised HTS (MucoClear 6%, PARI Pharma). Participants will be instructed to administer a 1 x 4 mL ampoule twice daily for 52 weeks using the eFlow rapid nebuliser and eTrack controller (PARI Pharma).
Hypertonic saline
Nebulized hypertonic saline solution (6%)
Standard Care and Carbocisteine
Standard care and carbocisteine (750 mg three-times-per-day until visit 3, reducing to 750 mg two times per day) over 52 weeks.
Carbocysteine 750 MG
Carbocisteine tablet
Standard Care and Combination of HTS and Carbocisteine
Standard care and combination of twice-daily nebulised HTS (MucoClear 6%, PARI Pharma) and carbocisteine. Participants will be instructed to administer a 1 x 4 mL ampoule twice daily for 52 weeks using the eFlow rapid nebuliser eFlow rapid nebuliser and eTrack controller (PARI Pharma). They will also be given carbocisteine (750 mg of three times per day until visit 3, reducing to 750 mg twice per day) over 52 weeks.
Hypertonic saline
Nebulized hypertonic saline solution (6%)
Carbocysteine 750 MG
Carbocisteine tablet
Standard Care Only
Standard care over 52 weeks. Patients in the standard care group will use airway clearance techniques in the management of their BE.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hypertonic saline
Nebulized hypertonic saline solution (6%)
Carbocysteine 750 MG
Carbocisteine tablet
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BE must be the primary respiratory diagnosis
* One or more pulmonary exacerbations in the last year requiring antibiotics\*
* Production of daily sputum
* Stable for 14 or more days before the first study visit with no changes to treatment
* Willing to continue any other existing chronic medication throughout the study
* Female subjects must be either surgically sterile, postmenopausal or agree to use effective contraception during the treatment period of the trial \*This can include patient reported exacerbations
Exclusion Criteria
* Patients with cystic fibrosis (CF)
* Patients with COPD as a primary respiratory diagnosis
* Current smokers, female ex-smokers with greater than 20 pack years and male ex-smokers with greater than 25 pack years.
* Forced expiratory volume in one second (FEV1) \<30%
* If being treated with long term macrolides, on treatment for less than one month before joining study
* Patients on regular isotonic saline
* Treatment with HTS, carbocisteine or any mucolytics within the past 30 days
* Known contraindication or intolerance to hypertonic saline or carbocisteine
* Hypersensitivity to any of the active ingredients or the excipients of carbocisteine
* Active peptic ulceration
* Any heredity galactose intolerance, the Lapp-Lactase deficiency or glucose-galactose malabsorption
* Patients unable to swallow oral capsules
* Women who are pregnant or lactating
* Participation in other trials of investigational products within 30 days
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Queen's University, Belfast
OTHER
Belfast Health and Social Care Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
J. Stuart Elborn
Role: PRINCIPAL_INVESTIGATOR
Queen's University, Belfast
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stoke Mandeville Hospital
Aylesbury, , United Kingdom
Belfast City Hospital, Belfast Health and Social Care Trust
Belfast, , United Kingdom
Queen Elizabeth Hospital, University Hospital Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, , United Kingdom
Bradford Teaching Hospitals
Bradford, , United Kingdom
Royal Brompton Hospital, Royal Brompton and Harefield NHS Foundation Trust
Brompton, , United Kingdom
Ninewells Hospital and Medical School, NHS Tayside
Dundee, , United Kingdom
Royal Infirmary Edinburgh, NHS Lothian
Edinburgh, , United Kingdom
Royal Free Hospital, Royal Free London NHS Foundation Trust
Hamstead, , United Kingdom
Princess Alexandra Hospital, The Princess Alexandra Hospital NHS Trust
Harlow, , United Kingdom
Royal Lancaster Infirmary, University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster, , United Kingdom
Cardiff & Vale University Heath Board
Llandough, , United Kingdom
Altnagelvin Area Hospital, Western Health and Social Care Trust
Londonderry, , United Kingdom
Milton Keynes University Hospital
Milton Keynes, , United Kingdom
Freeman Hospital, The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, , United Kingdom
Northumbria NHS Foundation Trust
North Shields, , United Kingdom
Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Royal Gwent Hospital, Aneurin Bevan University Health Board
Wales, , United Kingdom
Sandwell & West Birmingham
West Bromwich, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
16178SE-AS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.