RecruitingPhase 3Phase 4ACTRN12621000315819

BronchiEctasis Trial Testing ERdosteine (BETTER)

Evaluating the effect of erdosteine on respiratory exacerbation rate of children and adults with bronchiectasis - a double-blind, randomised controlled trial

Sponsor

Queensland University of Technology

Enrollment

205 participants

Start Date

May 27, 2021

Study Type

Interventional

Conditions

Bronchiectasis

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 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 RCT will answer: In children and adults aged <49 years with bronchiectasis, does 12 months treatment with erdosteine, compared to placebo, (i) reduce acute respiratory exacerbations and/or (ii) improve quality of life (QoL). The RCT will also determine the cost-effectiveness of the treatment.

Eligibility

Sex: Both males and femalesMin Age: 2 YearssMax Age: 49 Yearss

Inclusion Criteria3

Participants aged 2 to 49 years
Bronchiectasis with at least 2 acute respiratory exacerbations in the last 18 months AND
Able to be contacted for the 15 month follow up period.

Exclusion Criteria6

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) or nursing mothers
Previously randomised
Hospitalised in the last 4 weeks for respiratory instability
Participation in another intervention concurrent RCT.

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Interventions

Erdosteine: Oral twice daily doses for 12 months [<15 kg = 2.5mls/dose; 15-19 kg = 5mls/dose; 20-30 kg = 7.5ml/dose (or one capsule in children who can take capsules); >30 kg = 10ml/dose (or one capsule in participants who can take capsules)]. The formulation for liquid is powder for suspension. 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 RCT. 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.