Child Health, University of Aberdeen, Aberdeen, UK.
Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK.
Trials. 2019 Oct 4;20(1):573. doi: 10.1186/s13063-019-3500-7.
Childhood asthma is a common condition. Currently there is no validated objective test which can be used to guide asthma treatment in children. This study tests the hypothesis that the addition of fractional exhaled nitric oxide (FNO) monitoring in addition to standard care reduces the number of exacerbations (or attacks) in children with asthma.
This is a multi-centre, randomised controlled study. Children will be included of age 6-16 years who have a diagnosis of asthma, currently use inhaled corticosteroids (ICSs) and have had an exacerbation in the previous 12 months. Exclusion criteria include being unable to provide FNO measurement at baseline assessment, having another chronic respiratory condition and being currently treated with maintenance oral steroids. Participants will be recruited in both primary and secondary care settings and will be randomised to either receive asthma treatment guided by FNO plus symptoms (FNO group) or asthma treatment guided by symptoms only (standard care group). Within the FNO group, different treatment decisions will be made dependent on changes in FNO. Participants will attend assessments 3, 6, 9 and 12 months post randomisation. The primary outcome is asthma exacerbation requiring prescription and/or use of an oral corticosteroid over 12 months as recorded by the participant/parent or in general practitioner records. Secondary outcomes include time to first attack, number of attacks, asthma control score and quality of life. Adherence to ICS treatment is objectively measured by an electronic logging device. Participants are invited to participate in a "phenotyping" assessment where skin prick reactivity and bronchodilator response are determined and a saliva sample is collected for DNA extraction. Qualitative interviews will be held with participants and research nurses. A health economic evaluation will take place.
This study will evaluate whether FNO can provide an objective index to guide and stratify asthma treatment in children.
ISRCTN, ISRCTN67875351. Registered on 12 April 2017. Prospectively registered.
儿童哮喘是一种常见疾病。目前尚无经过验证的客观测试可用于指导儿童哮喘的治疗。本研究旨在检验以下假设，即通过添加呼出气一氧化氮（FENO）监测来指导哮喘治疗，可减少哮喘患儿的哮喘加重（或发作）次数。
这是一项多中心、随机对照研究。纳入的患儿年龄为 6-16 岁，诊断为哮喘，目前使用吸入性皮质类固醇（ICS），并且在过去 12 个月内有过哮喘加重。排除标准包括无法在基线评估时进行 FENO 测量、患有其他慢性呼吸系统疾病和目前正在接受维持性口服类固醇治疗。参与者将在初级和二级保健机构中招募，并随机分为接受 FENO 联合症状指导的哮喘治疗（FENO 组）或仅接受症状指导的哮喘治疗（标准护理组）。在 FENO 组中，将根据 FENO 的变化做出不同的治疗决策。参与者将在随机分组后 3、6、9 和 12 个月进行评估。主要结局是在 12 个月内需要处方和/或使用口服皮质类固醇治疗的哮喘加重，由参与者/家长或全科医生记录。次要结局包括首次发作的时间、发作次数、哮喘控制评分和生活质量。ICS 治疗的依从性通过电子记录器进行客观测量。参与者被邀请参加“表型”评估，其中包括皮肤点刺反应和支气管扩张剂反应的测定以及收集唾液样本进行 DNA 提取。将对参与者和研究护士进行定性访谈。将进行健康经济学评价。
本研究将评估 FENO 是否可以提供客观指标来指导和分层儿童哮喘的治疗。
ISRCTN，ISRCTN67875351。于 2017 年 4 月 12 日注册。前瞻性注册。
