Bronchiectasis Respiratory Bronchiectasis
Conditions
Interventions
Current interventions as of 06/08/2025:
Treatment allocation will be assigned using an automated randomisation process. Eligible participants will be allocated to one of the four treatment groups (thr
Sponsors
Belfast Health & Social Care Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 06/10/2022: 1. Diagnosis of BE on high resolution computed tomography (HRCT)/computed tomography (CT) scans 2. BE must be the primary respiratory diagnosis 3. One or more pulmonary exacerbations in the last year requiring antibiotics* 4. Production of daily sputum 5. Stable for 14 or more days before the first study visit with no changes to treatment 6. Willing to continue any other existing chronic medication throughout the study 7. 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 Previous inclusion criteria: 1. Diagnosis of BE on high resolution computed tomography (HRCT)/computed tomography (CT) scans 2. BE must be the primary respiratory diagnosis 3. Two or more pulmonary exacerbations in the last year requiring antibiotics* 4. Production of daily sputum 5. Stable for 14 or more days before the first study visit with no changes to treatment 6. Willing to continue any other existing chronic medication throughout the study 7. 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
Exclusion criteria: 1. Age <18 years old 2. Patients with CF 3. Patients with COPD as a primary respiratory diagnosis 4. Current smokers, female ex-smokers with greater than 20 pack years and male ex-smokers with greater than 25 pack years 5. FEV1<30% 6. If being treated with long term macrolides, on treatment for less than 1 month before joining study 7. Patients on regular isotonic saline 8. Treatment with HTS, carbocisteine or any mucolytics within the past 30 days 9. Known intolerance or contraindication to HTS or carbocisteine. 10. Hypersensitivity to any of the active ingredients or the excipients of carbocisteine 11. Active peptic ulceration 12. Any heredity galactose intolerance, the Lapp-Lactase deficiency or glucose-galactose malabsorption. 13. Patients unable to swallow oral capsules. 14. Women who are pregnant or lactating 15. Participation in another Clinical Trial of an Investigational Product within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean number of exacerbations over 52 weeks; exacerbations diagnosed as they occur via interview with patients and completion of the Respiratory and Systemic Symptoms questionnaire (RSSQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease-specific health-related quality of life (HRQoL) at 52 weeks measured using the respiratory symptoms domain of quality of life with bronchiectasis (QoL B) questionnaire completed at baseline, 2 weeks, 8 weeks, 26 weeks and 52 weeks 2. Time to next exacerbation post-randomisation measured in days, with exacerbations diagnosed as they occur via interview with patients and completion of the RSSQ 3. Number of days of antibiotics related to exacerbations over 52 weeks assessed via interview with patients at 2, 8, 26 and 52 weeks 4. Generic health-related quality of life (HRQoL) measured using the EQ-5D-5L questionnaire at baseline, 2 weeks, 8 weeks, 26 weeks and 52 weeks 5. Health Service use over 52 weeks assessed via completion of a questionnaire completed at baseline, 2 weeks, 8 weeks, 26 weeks and 52 weeks 6. Quality Adjusted Life Years (QALYs) over 52 weeks calculated by assessment of generic HRQoL measured using the EQ-5D-5L questionnaire completed at baseline, 2 weeks, 8 weeks, 26 weeks and 52 weeks 7. Health impairment measured using the St George’s Respiratory Questionnaire (SGRQ) at baseline, 2 weeks, 8 weeks, 26 weeks and 52 weeks 8. Patient preferences for treatment measured using a Treatment Satisfaction Questionnaire at 2, 8, 26, and 52 weeks 9. Adverse events over 52 weeks recorded as they occur by the PI or designee via interview with patients 10. Lung function over 52 weeks measured by spirometry testing at baseline, 2 weeks, 8 weeks, 26 weeks and 52 weeks 11. Adherence to HTS and carbocisteine over 52 weeks assessed via interview with patients at 2, 8, 26, and 52 weeks | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactAndrew;Andrew Jackson;Jackson
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Outcome results
None listed