Evidence map›Paper›PMID 38719503›Full record

ArticleBMJ open respiratory research2024

Erdosteine in children and adults with bronchiectasis (BETTER trial): study protocol for a multicentre, double-blind, randomised controlled trial.

Anne B Chang, Stephanie T Yerkovich, Katherine J Baines, Lucy Burr, Anita Champion, Mark D Chatfield, Kah P Eg, Vikas Goyal, Robyn L Marsh, Gabrielle B McCallum and 14 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open respiratory research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Mucolytics for children with chronic suppurative lung disease.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Trial
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Anne B ChangDepartment of Respiratory Medicine, Queensland Children's Hospital, South Brisbane, Queensland, Australia anne.chang@menzies.edu.au.ORCID http://orcid.org/0000-0002-1331-3706
Stephanie T YerkovichThe Australian Centre for Health Services Innovation (AusHSI), Queensland University of Technology, Brisbane, Queensland, Australia.
Katherine J BainesSchool of Medicine and Public Health, The University of Newcastle, Newcastle, New South Wales, Australia.
Lucy BurrMater Health Services, South Brisbane, Queensland, Australia.
Anita ChampionDepartment of Pharmacy, Queensland Children's Hospital, Brisbane, Queensland, Australia.
Mark D ChatfieldThe University of Queensland, Brisbane, Queensland, Australia.
Kah P EgDepartment of Paediatrics, Universiti Malaya Faculty of Medicine, Kuala Lumpur, Malaysia.
Vikas GoyalThe Australian Centre for Health Services Innovation (AusHSI), Queensland University of Technology, Brisbane, Queensland, Australia.
Robyn L MarshChild and Maternal Health Division and andand NHMRC Centre for Research Excellence in Paediatric Bronchiectasis (AusBREATHE), Menzies School of Health Research, Darwin, Northern Territory, Australia.
Gabrielle B McCallumChild and Maternal Health Division and andand NHMRC Centre for Research Excellence in Paediatric Bronchiectasis (AusBREATHE), Menzies School of Health Research, Darwin, Northern Territory, Australia.
Margaret McElreaThe Australian Centre for Health Services Innovation (AusHSI), Queensland University of Technology, Brisbane, Queensland, Australia.ORCID http://orcid.org/0000-0001-9078-2357
Steven McPhailThe Australian Centre for Health Services Innovation (AusHSI), Queensland University of Technology, Brisbane, Queensland, Australia.
Lucy C MorganDepartment of Respiratory Medicine, Concord Repatriation General Hospital, Concord, New South Wales, Australia.
Peter S MorrisChild and Maternal Health Division and andand NHMRC Centre for Research Excellence in Paediatric Bronchiectasis (AusBREATHE), Menzies School of Health Research, Darwin, Northern Territory, Australia.
Anne M NathanDepartment of Paediatrics, Universiti Malaya Faculty of Medicine, Kuala Lumpur, Malaysia.
Hannah O'FarrellThe Australian Centre for Health Services Innovation (AusHSI), Queensland University of Technology, Brisbane, Queensland, Australia.
Marion O SanchezSection of Pediatric Pulmonology, Institute of Pulmonary Medicine, St. Luke's Medical Center, Quezon City, Philippines.
Marianne ParsonsParent Advisory Group, Cough, Asthma and Airways Group, Queensland University of Technology Faculty of Health, Kelvin Grove, Queensland, Australia.
André SchultzDepartment of Respiratory Medicine, Princess Margaret Hospital for Children, Perth, Western Australia, Australia.
Paul J TorzilloRespiratory Medicine, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.
Nicholas P WestSchool of Medicine and Dentistry, Griffith University Griffith Health, Gold Coast, Queensland, Australia.
Lesley VersteeghChild and Maternal Health Division and andand NHMRC Centre for Research Excellence in Paediatric Bronchiectasis (AusBREATHE), Menzies School of Health Research, Darwin, Northern Territory, Australia.
Julie M MarchantDepartment of Respiratory Medicine, Queensland Children's Hospital, South Brisbane, Queensland, Australia.
Keith GrimwoodSchool of Medicine and Dentistry, Griffith University Griffith Health, Gold Coast, Queensland, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBronchiectasis is a worldwide chronic lung disorder where exacerbations are common. It affects people of all ages, but especially Indigenous populations in high-income nations. Despite being a major contributor to chronic lung disease, there are no licensed therapies for bronchiectasis and there remain relatively few randomised controlled trials (RCTs) conducted in children and adults. Our RCT will address some of these unmet needs by evaluating whether the novel mucoactive agent, erdosteine, has a therapeutic role in children and adults with bronchiectasis.Our primary aim is to determine in children and adults aged 2-49 years with bronchiectasis whether regular erdosteine over a 12-month period reduces acute respiratory exacerbations compared with placebo. Our primary hypothesis is that people with bronchiectasis who regularly use erdosteine will have fewer exacerbations than those receiving placebo.Our secondary aims are to determine the effect of the trial medications on quality of life (QoL) and other clinical outcomes (exacerbation duration, time-to-next exacerbation, hospitalisations, lung function, adverse events). We will also assess the cost-effectiveness of the intervention. METHODS AND ANALYSIS: We are undertaking an international multicentre, double-blind, placebo-RCT to evaluate whether 12 months of erdosteine is beneficial for children and adults with bronchiectasis. We will recruit 194 children and adults with bronchiectasis to a parallel, superiority RCT at eight sites across Australia, Malaysia and Philippines. Our primary endpoint is the rate of exacerbations over 12 months. Our main secondary outcomes are QoL, exacerbation duration, time-to-next exacerbation, hospitalisations and lung function. ETHICS AND DISSEMINATION: The Human Research Ethics Committees (HREC) of Children's Health Queensland (for all Australian sites), University of Malaya Medical Centre (Malaysia) and St. Luke's Medical Centre (Philippines) approved the study. We will publish the results and share the outcomes with the academic and medical community, funding and relevant patient organisations. TRIAL REGISTRATION NUMBER: ACTRN12621000315819.

Indexed as

BronchiectasisExpectorantsMulticenter Studies as TopicQuality of LifeThioglycolatesThiophenesAdolescentAdultChildChild, PreschoolDisease ProgressionDouble-Blind MethodEquivalence Trials as TopicFemaleHumansMaleerdosteineExpectorantsThioglycolatesThiophenesBronchiectasisPaediatric Lung Disaese

Identifiers

PMID38719503
PMCPMC11086403

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.