Assessment of Respiratory Symptoms After Corticosteroid Treatment Period Using Impedance Pneumography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Ability of IP measurement to distinguish patient subgroups
研究概览
简要总结
INTRODUCTION
Lung function assessment of preschool children is hindered by their limited co-operation in conventional tests such as peak expiratory flow (PEF) or spirometry and the methods available for younger children are, again, laborious and time consuming. However, impedance pneumography (IP) records indices of airway obstruction during normal sleep at home and has been shown accurate in wheezy preschool children (Seppä et al. J Appl Physiol 2013).
AIM OF THE STUDY
The general purpose of this study is to assess the clinical value of the information provided by overnight home recording of tidal breathing by means of IP technique in young children with asthmatic symptoms and inhaled corticosteroid (ICS) medication.
The main hypothesis is that IP measurement can distinguish between groups whose asthmatic symptoms recur or do not recur after ending the ICS drug treatment period.
METHODS
The study recruits 1-5 year old children (n=75) who have presented at the emergency room due to obstructive bronchitis and for whom an ICS drug treatment period has been prescribed based on the national guidelines.
The subjects will perform three overnight IP measurements at home at two weeks intervals close to and after ending of the treatment period.
SIGNIFICANCE OF THE STUDY
Being an affordable, simple and convenient ambulatory measurement method, IP may bring needed objectivity to asthma diagnostics and asthma drug response assessment in young children.
详细描述
QUALITY CONTROL AND QUALITY ASSURANCE
Information of study personnel and training All personnel involved with the use of the IP measurement device will be instructed by Ville-Pekka Seppä.
Protocol amendments Essential amendments in the research protocol will be reviewed by the institutional review board and informed to National Supervisory Authority of Welfare and Health (Valvira).
DATA HANDLING AND RECORD KEEPING Electronic data collection Electronic data will consist of IP recorder device data files (.ipr). Upon complete protocol execution there will be three files for each patient. These files will be stored in a computer in TAYS Allergiakeskus.
Data management Access to all collected patient information and the patient information collected before the study in the primary care centers will be accessible to RN Tiina Mäki (0503439195), MD Marita Paassilta, and MD Jussi Karjalainen of Allergiakeskus.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1-5 yrs
- •Recurrent obstructive bronchitis
- •Inhaled corticosteroid treatment has been prescribed
排除标准
- •Laryngeal disease
- •Tracheobronchial malacia
- •Parenchymal lung disease
- •History of bronchopulmonary dysplasia
- •Active implantable medical such as pacemakers
结局指标
主要结局
Ability of IP measurement to distinguish patient subgroups
时间窗: 1 wk before to 4 weeks after end of ICS period
Comparison of the measures derived from the IP measurement (the investigational device) between the subgroups in the cohort at three times: 1 wk before end of ICS period, 1-2 wk after ending ICS period, 3-4 wk after ending ICS period
次要结局
未报告次要终点
研究者
Jussi Karjalainen
MD
Tampere University Hospital