Exhaled Nitric Oxide and Airway Caliber in Children With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in M/P40 ratio from baseline at 4 weeks of treatment with inhaled steroid
研究概览
简要总结
The purpose of this study is to assess if in steroid naïve asthmatic children with elevated baseline exhaled nitric oxide, treatment with inhaled steroid and normalization of exhaled nitric oxide level results in restoration of the bronchodilator response to deep inhalation.
详细描述
Previous studies have shown that a deep inhalation (DI) would increase airway caliber in normal subjects. Whereas in asthmatics with spontaneous bronchoconstriction (obstruction of the airway), DI was shown to worsen airway obstruction. The mechanism for this variability in response to DI is not well-understood, but seems to be a key in understanding the pathophysiology of the disease, and possibly in the development of an effective therapy. Air way inflammation resulting in airway wall thickening and peribronchial edema is thought to play a role how the airway responds to deep inhalation. This study assess if reduction in airway inflammation (as measured by level of exhaled NO)results in optimization of the bronchodilator response to deep inhalation
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: > 6 years at age of screening.
- •Physician diagnosed asthma
- •Elevated exhaled NO at initial evaluation (>25ppb)
- •Be able to reproducibly perform DI maneuvers and all other pulmonary function testing
- •Be clinically stable for at least 2 weeks prior to screening with no evidence of acute upper or lower respiratory infection or current pulmonary exacerbation.
- •Has not been on inhaled or oral steroid for at least 4 weeks prior to enrollment in the study.
- •Parent/child willingness to enroll in the study and provide written informed consent.
- •Be able to present for the required study visits.
排除标准
- •Chest wall or spinal column deformity; known cardiac, neuromuscular, or other chronic diseases
- •Use of beta agonist, theophylline, leukotriene receptor antagonists, or caffeine-containing soft drinks 12 hr prior to the study.
- •Use of inhaled steroid in the past 4 weeks.
- •Respiratory infection or asthma exacerbation in the previous 2 weeks
结局指标
主要结局
Change in M/P40 ratio from baseline at 4 weeks of treatment with inhaled steroid
时间窗: at baseline and 4 weeks later
M/P40 ratio is defined as the ratio of flow at 40% of FVC (forced vital capacity) on the flow-volume curve after maximal inspiration to flow at 40% of FVC on the flow-volume curve after partial (60%-70% of FVC) inspiration (M/P40 ratio)
次要结局
- Change in Ratio of post DI to pre DI airway resistance from baseline at 4 weeks of treatment with inhaled steroid(at baseline and 4 weeks later)
研究者
Patricia Breitwieser
Coordiantor, Respiratory Center for Children
Atlantic Health System