Participants with Chronic Obstructive Pulmonary Disease that have either chronic bronchitis and/or associated bronchiectasis that have self-reported difficulty self-expectorating Respiratory
Conditions
Interventions
Participants will be randomised on a 1:1 basis to nebulised 7% sodium chloride plus ACBT or 750mg carbocisteine plus ACBT.
The randomisation system will include allocation concealment and stratificati
Sponsors
Accord (United Kingdom)
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients =18 years old 2. Have COPD as the predominant respiratory diagnosis 3. Meet Medical Research Council (MRC) definition of chronic bronchitis, defined epidemiologically as cough and sputum production for =3 months per year in at least 2 consecutive years and/or have associated bronchiectasis on computed tomography of the chest 4. Self-reported difficulty in expectoration (determined from the medical notes and/or participant). If from the participant, this will be documented in the medical notes
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 16/12/2022: 1. Patients that do not have the capacity to consent (determined by clinician or member of the research team) 2. Patients with active malignancy 3. Patients with a solid organ transplant 4. Patients with active tuberculosis 5. Patients who are in end-of-life care 6. Patients who have had treatment with nebulised hypertonic sodium chloride, carbocisteine or any muco-active treatments within the past 7 days* 7. Patients who are established on long-term antibiotic therapy for less than 3 months 8. Patients who have had an exacerbation within the past 14 days requiring treatment with antibiotics and/or steroids** 9. Known contraindication or intolerance to nebulised 7% sodium chloride or carbocisteine or any hypersensitivity to the active ingredients or the excipients of carbocisteine 10. Active peptic ulceration; any known hereditary galactose intolerance, Lapp-Lactase deficiency or glucose-galactose malabsorption 11. Women who are pregnant or currently breastfeeding 12. Women of childbearing potential*** not taking appropriate contraception****. Contraception must be continued for a minimum of 30 days after the end of the IMP dosing schedule. 13. Participation in another Clinical Trial of an Investigational Medicinal Product (CTIMP) within the last 30 days 14. Previous recruitment to the study 15. Participants indicating that they are unable to comply with the study protocol prior to randomisation including those unable to complete participant questionnaires *If participants have been on treatment with nebulised 7% sodium chloride, carbocisteine or any muco-active treatments within the past 7 days, they need to come off these treatments for 7 days and remain clinically stable in order to be eligible for the study **14 days from the start of the recent exacerbation *** A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. ****Acceptable contraception in women of childbearing age is a “highly effective” contraceptive measure as defined by the Clinical Trials Facilitation Group and includes combined (oestrogen and progesterone containing) or progesterone-only contraception associated with inhibition of ovulation, or intrauterine device or bilateral tubal occlusion (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf). Previous participant exclusion criteria: 1. Patients that do not have capacity to consent (determined by clinician or member of the research team) 2. Patients with an active malignancy 3. Patients with a solid organ transplant 4. Patients with active tuberculosis 5. Patients who are in end-of-life care 6. Patients who have had treatment with nebulised hypertonic sodium chloride, carbocisteine or any muco-active treatments within the past 30 days* 7. Patients established on long-term antibiotic therapy for less than 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Impact of COPD measured using the COPD Assessment Test (CAT) at baseline and one year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health related quality of life: 1.1. CAT score at baseline and 6 months 1.2. Quality of life assessment using the Leicester Cough Questionnaire and St. George’s Respiratory Questionnaire at 6 months and 1 year 2. Exacerbations and time to first exacerbation: 2.1. Number of exacerbations over a one year period requiring antibiotic therapy and/or systemic steroid treatment measured using exacerbation diaries when exacerbation is reported by the patient 2.2. Time to first exacerbation requiring antibiotic therapy and/or systemic steroids over one year measured using exacerbation diaries when exacerbation is reported by the participant 2.3. Proportion of exacerbations needing antibiotic therapy over one year measured using exacerbation diaries when exacerbation is reported by the patient and concomitant medication recording 2.4. Number of upper respiratory tract infections (URTI) over a one year period) assessed using the Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) 2.5. Overall and COPD related hospital attendances/admissions over one year measured using healthcare usage questionnaire at baseline, 6 months and 12 months 2.6. Use of nebulised 7% sodium chloride in exacerbations measured using participant reported daily diaries 3. Potential pathogen microorganisms and viruses from sputum samples and combined nose and throat swabs: 3.1. Proportion being infected with a potential pathogenic organism and viruses at 6 months and one year (from sputum samples and combined nose and throat swabs (if taken as part of standard care)) 4. Viral transmissibility (household contacts to participant and participant to household contacts) measured using participant reported daily diaries 5. Lung function: 5.1. Forced Expired Volume in 1 second (FEV1), forced vital capacity (FVC) and mid-expiratory flows at 6 months and one year 6. Health economic benefits: 6.1. Cost per Quality Adjusted Life Year (QALY) a) over one year and b) modelled over a lifetime horizon measured | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactEmma Ward
Outcome results
None listed