Randomised Open Label Trial of Hypertonic Saline and Carbocisteine in Bronchiectasis (CLEAR)
Key facts
- Phase
- Phase 3
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Trial details
- Who runs it
- Belfast Health and Social Care Trust
- Trial code
- NCT04140214
- Record updated
- 2 May 2025
- Original description
Patients with bronchiectasis (BE) suffer from a persistent cough, daily sputum expectoration, recurrent chest infections, and a poor health-related quality of life. Current guidelines for the management of BE highlight the lack of evidence to recommend mucoactive agents, such as hypertonic saline (HTS) and carbocisteine, to aid sputum-removal as part of standard care. The investigators hypothesise that mucoactive agents (HTS or cabocisteine, or a combination of both) are effective in reducing exacerbations over a 52-week period, compared to usual care.Read full original descriptionShow less
A 2x2 Factorial Randomized 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
Patients with bronchiectasis (BE) suffer from a persistent cough, daily sputum expectoration, recurrent chest infections, and a poor health-related quality of life. Current guidelines for the management of BE highlight the lack of evidence to recommend mucoactive agents, such as hypertonic saline (HTS) and carbocisteine, to aid sputum-removal as part of standard care. The investigators hypothesise that mucoactive agents (HTS or cabocisteine, or a combination of both) are effective in reducing exacerbations over a 52-week period, compared to usual care.
Inclusion: Diagnosis of BE on high resolution computed tomography(HRCT)/computed tomography (CT) scans; 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: If being treated with long term macrolides, on treatment for less than one month before joining study; Treatment with HTS, carbocisteine or any mucolytics within the past 30 days; Participation in other trials of investigational products within 30 days; Hypersensitivity to any of the active ingredients or the excipients of carbocisteine; Any heredity galactose intolerance, the Lapp-Lactase deficiency or glucose-galactose malabsorption; Age <18 years old; 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%; Patients on regular isotonic saline; Known contraindication or intolerance to hypertonic saline or carbocisteine; Active peptic ulceration; Patients unable to swallow oral capsules; Women who are pregnant or lactating.