跳至主要内容
临床试验/NCT01095354
NCT01095354已完成不适用

Investigation of Lung Ventilation Inhomogeneity in Pediatric Asthma: Multiple Breath Washout and Asthma

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2009年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
1
主要终点
Lung Clearance Index (LCI)

研究概览

简要总结

The primary objective of this study is to determine if well-controlled asthmatic patients followed in subspecialty asthma clinics between the ages of 3 - 18 years can be distinguished from healthy controls using lung clearance index, a parameter from the multiple breath washout test. Also, to correlate lung clearance index with asthma sputum cell counts.

详细描述

Clinical studies are underway which are examining the utility of the LCI in obstructive respiratory disease (cystic fibrosis and asthma). However, the majority of studies have examined asthmatics with ongoing evidence of reversible disease on spirometry. There is a very limited body of research comparing LCI values in well-controlled asthmatics to healthy controls. Furthermore, the type of inflammation occurring in asthma may have a different site of action, we will prospectively study whether there is a difference in LCI between eosinophilic and neutrophilic inflammation to give us an indication of whether the site of non-eosinophilic inflammation is primarily in the small airways as well.

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
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Asthma Subjects:
  • 3 - 18 years of age at enrolment
  • Clinically stable at enrolment
  • Physician diagnosis of asthma and attending follow-up in the Asthma Clinic

排除标准

  • Asthma Subjects:
  • Born premature (before 37 weeks gestational age)
  • Low birth weight (less than 2.5 kilograms)
  • History of congenital heart disease, neuromuscular disorder or bone disease
  • History of any chronic lung disease other than asthma
  • Respiratory infection in last three weeks
  • Change in medication in last three weeks (including oral steroids)
  • Current or previous history of smoking

研究组 & 干预措施

Asthma Patients

Spirometry. Bronchodilator with Salbutamol. Induced sputum in > 10 years of age using Sodium Chloride Inhalation. Multiple Breath Washout (MBW).

干预措施: Sodium Chloride Inhalation (Drug)

结局指标

主要结局

Lung Clearance Index (LCI)

时间窗: Day 1

Lung clearance index will be compared between healthy and asthmatic patients after they have performed Pulmonary Function Testing and Multiple Breath Washout

次要结局

  • Correlation of sputum cell counts with LCI(Day 1)
  • Effect of bronchodilator on baseline and post-spirometry LCI(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Padmaja Subbarao

Staff Respirologist

The Hospital for Sick Children

研究点 (1)

Loading locations...

相似试验

Investigation of Lung Ventilation Inhomogeneity in... | 临床试验