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Background: Asthma is the most common chronic childhood respiratory condition globally. Inhaled corticosteroid (ICS)-formoterol reliever-based regimens reduce the risk of asthma exacerbations compared with conventional short-acting β 2 -agonist (SABA) reliever-based regimens in adults and adolescents. The current limited evidence for anti-inflammatory reliever therapy in children means it is unknown whether these findings are also applicable to children. High-quality randomised controlled trials (RCTs) are needed., Objective: The study aim is to determine the efficacy and safety of budesonide-formoterol reliever alone or maintenance and reliever therapy (MART) compared with standard therapy: budesonide or budesonide-formoterol maintenance, both with terbutaline reliever, in children aged 5 to 11 years with mild, moderate and severe asthma., Methods: A 52-week, multicentre, open-label, parallel group, phase III, two-sided superiority RCT will recruit 400 children aged 5 to 11 years with asthma. Participants will be randomised 1:1 to either budesonide-formoterol 100/6 µg Turbuhaler reliever alone or MART; or budesonide or budesonide-formoterol Turbuhaler maintenance, with terbutaline Turbuhaler reliever. The primary outcome is moderate and severe asthma exacerbations as rate per participant per year. Secondary outcomes are asthma control, lung function, exhaled nitric oxide and treatment step change. Assessment of Turbuhaler technique and cost-effectiveness analysis are also planned., Conclusion: This will be the first RCT to compare the efficacy and safety of a step-wise budesonide-formoterol reliever alone or MART regimen with conventional inhaled ICS or ICS-long-acting β-agonist maintenance plus SABA reliever in children. The results will provide a much-needed evidence base for the treatment of asthma in children., Competing Interests: Conflict of interest: L. Fleming reports consulting fees from AstraZeneca, Sanofi Regeneron and GSK, outside the submitted work; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events for AstraZeneca, Novartis and Sanofi Regeneron, outside the submitted work. Conflict of interest: C.A. Byrnes reports grants or contracts from the National Health and Medical Research Council Australia, Fisher & Paykel, the Buddle Findlay & Paul Stevenson Memorial Fund and FluLab, outside the submitted work; participation on a Clinical Advisory Panel for Cystic Fibrosis New Zealand and as a Bronchiectasis Foundation Trustee, outside the submitted work; and is a group for Chair, Respiratory Network, Paediatric Society of New Zealand, and a member of the Royal Australasian College of Physicians Paediatric Research Committee, outside the submitted work. Conflict of interest: D. McNamara reports participation on a data safety monitoring board or advisory board for PRECARE study primary outcome arbitration committee, outside the submitted work; leadership or fiduciary role in other board, society, committee or advocacy group for Co-Chair NZ Paediatric Respiratory and Sleep Clinical Network Reference Group, and Member Scientific Advisory Board, Asthma and Respiratory Foundation of NZ, outside the submitted work. Conflict of interest: S.R. Dalziel reports grants or contracts from Cure Kids New Zealand, Health Research Council New Zealand and Starship Foundation, outside the submitted work. Conflict of interest: R. Beasley reports receiving support for the present manuscript from AstraZeneca; grants or contracts from AstraZeneca, Genentech, HRC (NZ) and Cure Kids NZ, outside the submitted work; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from AstraZeneca, Avillion, Cipla, Teva and CSL Seqirus, outside the submitted work; support for attending meetings and/or travel from AstraZeneca, Avillion, Cipla, Teva and CSL Seqirus, outside the submitted work; NZ asthma guidelines chair, and GOLD board member, disclosures made outside the submitted work; and receipt of equipment, materials, drugs, medical writing, gifts or other services from AstraZeneca, outside the submitted work. Conflict of interest: The remaining authors have nothing to disclose., (Copyright ©The authors 2024.)

Background: Eczema is a chronic, relapsing skin condition commonly managed by emollients and topical corticosteroids. Prevalence of use and demand for effective botanical therapies for eczema is high worldwide, however, clinical evidence of benefit is limited for many currently available botanical treatment options. Robustly-designed and adequately powered randomised controlled trials (RCTs) are essential to determine evidence of clinical benefit. This protocol describes an RCT that aims to investigate whether a mānuka oil based emollient cream, containing 2% ECMT-154, is a safe and effective topical treatment for moderate to severe eczema., Methods: This multicentre, single-blind, parallel-group, randomised controlled trial aims to recruit 118 participants from community pharmacies in Aotearoa New Zealand. Participants will be randomised 1:1 to receive topical cream with 2% ECMT-154 or vehicle control, and will apply assigned treatment twice daily to affected areas for six weeks. The primary outcome is improvement in subjective symptoms, assessed by change in POEM score. Secondary outcomes include change in objective symptoms assessed by SCORAD (part B), PO-SCORAD, DLQI, and treatment acceptability assessed by TSQM II and NRS., Discussion: Recruitment through community pharmacies commenced in January 2022 and follow up will be completed by mid-2023. This study aims to collect acceptability and efficacy data of mānuka oil based ECMT-154 for the treatment of eczema. If efficacy is demonstrated, this topical may provide an option for a novel emollient treatment. The community-based design of the trial is anticipated to provide a generalisable result., Ethics and Dissemination: Ethics approval was obtained from Central Health and Disability Ethics Committee (reference: 2021 EXP 11490). Findings of the study will be disseminated to study participants, published in peer-reviewed journal and presented at scientific conferences., Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621001096842. Registered on August 18, 2021 ( https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382412&isReview=true )., Protocol Version: 2.1 (Dated 18/05/2022)., (© 2024. The Author(s).)

Background: Māori, the indigenous people of New Zealand, have traditionally used the kānuka tree as part of their healing system, Rongoā Māori, and the oil from the kānuka tree has demonstratable anti-inflammatory and anti-bacterial properties. This trial investigated the efficacy and safety of a 3% kānuka oil (KO) cream compared to vehicle control (VC) for the topical treatment of eczema. The trial was conducted through a nationwide community pharmacy research network., Methods: This single-blind, parallel-group, randomised, vehicle-controlled trial was undertaken in 11 research trained community pharmacies across New Zealand. Eighty adult participants with self-reported moderate-to-severe eczema, assessed by Patient Orientated Eczema Measure (POEM) were randomised by blinded investigators to apply 3% KO cream or VC topically, twice daily, for six weeks. Randomisation was stratified by site and eczema severity, moderate versus severe. Primary outcome was difference in POEM scores at week six between groups by intention to treat. The study is registered on the Australian New Zealand Clinical Trial Registry (ANZCTR) reference number, ACTRN12618001754235., Findings: Eighty participants were recruited between 17 May 2019 and 10 May 2021 (41 KO group, 39 VC group). Mean POEM score (standard deviation) improved between baseline and week six for KO group, 18·4 (4·4) to 6·8 (5·5), and VC group, 18·7 (4·5) to 9·8 (6·5); mean difference between groups (95% confidence interval) was -3·1 (-6·0 to -0·2), p  = 0·036. There were three adverse events reported in the KO group related to the intervention and two in the control group., Interpretation: The KO group had a significant improvement in POEM score compared to VC. Rates of adverse events and withdrawals were similar between groups with no serious adverse events reported. Treatment acceptability was high for both groups across all domains. Our results suggest that in adults with moderate-to-severe eczema, the addition of KO to a daily emollient regimen led to a reduction in POEM score compared to VC. KO may represent an effective, safe, and well tolerated treatment for moderate-to-severe eczema in adults., Funding: Hikurangi Bioactives (Ruatoria, New Zealand) and HoneyLab (Tauranga, New Zealand), supported by a grant from Callaghan Innovation., Competing Interests: All authors have completed the ICMJE uniform disclosure form. R.B., A.S., and N.S. declare funding from Hikuangi Bioactives and Honeylab to the MRINZ for the submitted work. All other authors declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work., (© 2022 The Author(s).)