Department of (Pediatric) Dermatology and Allergology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
Trials. 2014 Mar 26;15:94. doi: 10.1186/1745-6215-15-94.
About 10 to 20% of children in West European countries have atopic dermatitis (AD), often as part of the atopic syndrome. The full atopic syndrome also consists of allergic asthma, allergic rhinitis and food allergy. Treatment approaches for atopic dermatitis and asthma include intermittent anti-inflammatory therapy with corticosteroids, health education and self-management training. However, symptoms persist in a subgroup of patients. Several observational studies have shown significant improvement in clinical symptoms in children and adults with atopic dermatitis or asthma after treatment at high altitude, but evidence on the efficacy when compared to treatment at sea level is still lacking.
METHODS/DESIGN: This study is a pragmatic randomized controlled trial for children with moderate to severe AD within the atopic syndrome. Patients are eligible for enrolment in the study if they are: diagnosed with moderate to severe AD within the atopic syndrome, aged between 8 and 18 years, fluent in the Dutch language, have internet access at home, able to use the digital patient system Digital Eczema Center Utrecht (DECU), willing and able to stay in Davos for a six week treatment period. All data are collected at the Wilhelmina Children's Hospital and DECU. Patients are randomized over two groups. The first group receives multidisciplinary inpatient treatment during six weeks at the Dutch Asthma Center in Davos, Switzerland. The second group receives multidisciplinary treatment during six weeks at the outpatient clinic of the Wilhelmina Children's Hospital, Utrecht, the Netherlands. The trial is not conducted as a blind trial. The trial is designed with three components: psychosocial, clinical and translational. Primary outcomes are coping with itch, quality of life and disease activity. Secondary outcomes include asthma control, medication use, parental quality of life, social and emotional wellbeing of the child and translational parameters.
The results of this trial will provide evidence for the efficacy of high altitude treatment compared to treatment at sea level for children with moderate to severe AD.
Current Controlled Trials ISRCTN88136485.
西欧国家约有 10%至 20%的儿童患有特应性皮炎（AD），通常作为特应性综合征的一部分。特应性综合征还包括过敏性哮喘、过敏性鼻炎和食物过敏。特应性皮炎和哮喘的治疗方法包括间歇性使用皮质类固醇进行抗炎治疗、健康教育和自我管理培训。然而，在一部分患者中，症状仍然存在。几项观察性研究表明，在高海拔地区治疗后，患有特应性皮炎或哮喘的儿童和成人的临床症状有显著改善，但与海平面治疗相比，其疗效的证据仍然缺乏。
方法/设计：本研究是一项针对特应性综合征中中重度 AD 儿童的实用随机对照试验。如果患者符合以下条件，即可有资格参加研究：被诊断为特应性综合征中的中重度 AD，年龄在 8 至 18 岁之间，精通荷兰语，家中有互联网接入，能够使用数字患者系统乌得勒支数字湿疹中心（DECU），愿意并能够在达沃斯停留六周治疗期。所有数据均在威廉敏娜儿童医院和 DECU 收集。患者随机分为两组。第一组在瑞士达沃斯的荷兰哮喘中心接受六周的多学科住院治疗。第二组在荷兰乌得勒支威廉敏娜儿童医院的门诊接受六周的多学科治疗。该试验不是作为盲法试验进行的。该试验设计有三个组成部分：心理社会、临床和转化。主要结局是应对瘙痒、生活质量和疾病活动。次要结局包括哮喘控制、药物使用、父母生活质量、儿童的社会和情感幸福感以及转化参数。
该试验的结果将为高海拔治疗与海平面治疗对中重度 AD 儿童的疗效提供证据。
当前对照试验 ISRCTN88136485。
