Victoria Bell, Nicole Sergenson, Seonaidh Cotton, Chukwuemeka David Emele, Ruth Thomas, Lorna Aucott, Mark Forrest, Erol A Gaillard, Erika J Kennington, Graeme MacLennan, Ian Sinha, Thenmalar Vadiveloo, Neil W Scott, Steve Turner
{"title":"Spirometry to manage asthma in children: study protocol for a randomised controlled trial (SPIROMAC).","authors":"Victoria Bell, Nicole Sergenson, Seonaidh Cotton, Chukwuemeka David Emele, Ruth Thomas, Lorna Aucott, Mark Forrest, Erol A Gaillard, Erika J Kennington, Graeme MacLennan, Ian Sinha, Thenmalar Vadiveloo, Neil W Scott, Steve Turner","doi":"10.1186/s13063-025-09104-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Asthma affects over 1 million children across the UK, and preventative treatment is guided subjectively by patient symptoms. Spirometry is an objective test of lung function and can be used in children to guide treatment. However, current guidelines do not indicate how asthma treatment should change in the context of changing spirometry results. This study will evaluate how spirometry can be used to guide asthma treatment and reduce the risk for asthma attacks in children.</p><p><strong>Methods: </strong>This is a multi-centre, randomised controlled trial. Children aged 6-15 years, who have a diagnosis of asthma and have had an exacerbation requiring oral or intravenous corticosteroids in the previous 12 months, will be eligible. Exclusion criteria include being unable to provide spirometry measurement at baseline assessment, having another chronic respiratory condition and being currently treated with maintenance oral steroids or biologicals. Participants will be recruited in both primary and secondary care settings and will be randomised to either receive asthma treatment guided by spirometry plus symptoms (intervention group) or asthma treatment guided by symptoms only (standard care group). Within the spirometry group, treatment recommendations will be dependent on changes in spirometry measurements. Participants will attend assessments 3, 6, 9 and 12 months post-randomisation, where treatment recommendations will be made. The primary outcome is the number of asthma attacks per participant requiring treatment with 1-7 days of oral or intravenous corticosteroid over 12 months, as recorded by the participant or parent. Secondary outcomes include time to first attack, any asthma attack, adverse events, dose of inhaled corticosteroids, asthma control and quality of life. Adherence to inhaled corticosteroid treatment is measured by an electronic logging device.</p><p><strong>Discussion: </strong>This study will evaluate whether asthma treatment guided by spirometry will reduce future asthma attacks in children. Our findings may be relevant to national and international asthma guidelines.</p><p><strong>Trial registration: </strong>ISRCTN, ISRCTN31849868. Registered on 01.07.2022. Prospectively registered.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"373"},"PeriodicalIF":2.0000,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12482643/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Trials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13063-025-09104-1","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Asthma affects over 1 million children across the UK, and preventative treatment is guided subjectively by patient symptoms. Spirometry is an objective test of lung function and can be used in children to guide treatment. However, current guidelines do not indicate how asthma treatment should change in the context of changing spirometry results. This study will evaluate how spirometry can be used to guide asthma treatment and reduce the risk for asthma attacks in children.
Methods: This is a multi-centre, randomised controlled trial. Children aged 6-15 years, who have a diagnosis of asthma and have had an exacerbation requiring oral or intravenous corticosteroids in the previous 12 months, will be eligible. Exclusion criteria include being unable to provide spirometry measurement at baseline assessment, having another chronic respiratory condition and being currently treated with maintenance oral steroids or biologicals. Participants will be recruited in both primary and secondary care settings and will be randomised to either receive asthma treatment guided by spirometry plus symptoms (intervention group) or asthma treatment guided by symptoms only (standard care group). Within the spirometry group, treatment recommendations will be dependent on changes in spirometry measurements. Participants will attend assessments 3, 6, 9 and 12 months post-randomisation, where treatment recommendations will be made. The primary outcome is the number of asthma attacks per participant requiring treatment with 1-7 days of oral or intravenous corticosteroid over 12 months, as recorded by the participant or parent. Secondary outcomes include time to first attack, any asthma attack, adverse events, dose of inhaled corticosteroids, asthma control and quality of life. Adherence to inhaled corticosteroid treatment is measured by an electronic logging device.
Discussion: This study will evaluate whether asthma treatment guided by spirometry will reduce future asthma attacks in children. Our findings may be relevant to national and international asthma guidelines.
Trial registration: ISRCTN, ISRCTN31849868. Registered on 01.07.2022. Prospectively registered.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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