Feasibility study of 2-weeks of erdosteine used during exacerbations in children with bronchiectasis
Evaluating the effect of 2-weeks erdosteine, a novel mucolytic, as add-on treatment during respiratory exacerbations in children with bronchiectasis - a feasibility study
Queensland University of Technology
30 participants
Jan 6, 2025
Interventional
Conditions
Summary
Bronchiectasis is a commonly seen chronic lung disease in our inpatient and outpatient services. The unmet needs of people with bronchiectasis are huge, with relatively few randomised controlled trials (RCTs) and evidence-based interventions. This pilot RCT aims to improve the outcomes of children and young adults with bronchiectasis. It will examine the benefits (or otherwise) of a novel medication, erdosteine. Erdosteine’s effects include (a) mucolytic action, modulation of mucus production and increasing muco-ciliary transport; with (b) antioxidant; (c) airway anti-inflammatory and; (d) bacterial anti-adhesion properties. This pilot RCT will answer: In children (aged 2-18 years) with bronchiectasis, does 2 weeks of treatment with erdosteine as an add-on therapy, compared to placebo, (i) reduce the duration of the acute respiratory exacerbation, (ii) improve quality of life (QoL) and/or (iii) increase the time to next respiratory exacerbation.
Eligibility
Inclusion Criteria3
- Participants aged 2 to 18 years who have chest computed tomography (CT) proven bronchiectasis
- Participants have had at least 2 acute respiratory exacerbations in the last 18 months requiring antibiotics OR one hospitalisation for treatment of a respiratory exacerbation
- Able to be contacted for the 12 month follow up period.
Exclusion Criteria7
- Cystic fibrosis
- Contraindication to erdosteine use (e.g. liver dysfunction, hypersensitivity, renal failure, deficiency of the cystathionine-synthetase enzyme, phenylketonuria, active peptic ulcer)
- Pregnant, pregnancy planned (in next 12 months)
- Participation in another concurrent randomised controlled trial
- Taking tacrolimus, sirolimus, everolimus and cyclosporin
- Past (treatment within the last 6 months) or current infection with non-tuberculous mycobacteria.
- Diagnosed with tuberculosis infection and still considered contagious
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Interventions
Erdosteine 300mg capsules: Oral twice daily doses for 2 weeks [one capsule (300mg) per dose for children >20kg; half capsule (150mg) per dose for children 15-20kg] Adherence will be monitored by return of bottles or capsule packaging. In a subset of participants, we will also evaluate if inflammatory and/or microbial biomarkers will identify pathways and/or predict those at greater risk of recurrent respiratory exacerbations. These outcomes will not be reported in the trial. Participants for this component will be based on whether they consent to these additional procedures (sputum and blood). Where possible, bloods and sputum will be taken at baseline and at commencement of an exacerbation.
Locations(1)
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ACTRN12624001381572