Modulation Of Airway Reactivity With Chronic Mechanical Strain
2021年2月17日 更新者：Robert Tepper、Indiana University
The purpose of this study is to see if the use of a machine called CPAP will help children with asthma breathe better.
CPAP is a machine that produces airflow to help people with breathing problems.
To use it, you will wear a mask connected by a hose to the CPAP machine.
We believe that use of CPAP may be a treatment for children with asthma.
研究概览
地位
完全的
条件
详细说明
During the previous funding period of this project, our laboratory demonstrated that chronic mechanical strain imposed on the airways in vivo using continuous positive airway pressure (CPAP) results in a dramatic reduction in airway reactivity in vivo in mice, ferrets and rabbits1-3.
Lungs, airways and airway smooth muscle (ASM) tissues isolated from CPAP-treated animals studied in vitro exhibited lower responsiveness to bronchoconstrictors1-3.
We also observed this suppression of airway responsiveness by chronic mechanical strain in a rabbit model of allergic asthma5.
These animal studies led to a small clinical trial in which adults with asthma were treated with nocturnal CPAP for 1 week.
CPAP caused a significant reduction in airway reactivity in these patients6.
This novel approach for treating airway hyper-reactivity is currently being evaluated in a NIH multi-center Phase II clinical trial of adults with mild to moderate asthma (U01 HL108730).
研究类型
介入性
注册 (实际的)
84
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Indiana
-
Indianapolis、Indiana、美国、46202
- Riley Hospital for Children
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
8年 至 17年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Children 8-17 yrs olds with severe asthma (N=120) will be recruited from the Pediatric High Risk Asthma Clinic and Pulmonary Clinics at Riley Hospital for Children at Indiana University Health.
- Severe asthma will be defined by the need for medication therapies following steps 4-6 according to the National Institutes of Health's Asthma Care Quick Reference, September 2012 or high dose of inhaled corticosteroids
- On a stable regimen of asthma medications for at least 8 weeks prior to enrollment without systemic corticosteroids for ≥ 4 weeks
Exclusion Criteria:
- Obese (>95% predicted BMI)
- Congenital heart disease or chronic lung disease
- History of pneumothorax
- Inability to perform pulmonary function testing
- Oxygen saturation <93%
- forced expiratory volume at one second (FEV1) <70% predicted
- Provocative concentration causing a 20% drop in FEV1 from baseline (PC20) ≥16 mg/ml of methacholine.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Continuous Positive Airway Pressure (CPAP)
Use of a CPAP machine for at least 5 days per week for 28 days
|
Subjects assigned to this group will be asked to use the CPAP machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.
|
|
假比较器：Continuous Positive Airway Pressure (CPAP) Sham
Use of a sham CPAP machine for at least 5 days per week for 28 days
|
Subjects assigned to this group will be asked to use the CPAP Sham machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Airway Reactivity From Baseline (Visit 1) and 4 Weeks (Visit 2)
大体时间：baseline (visit 1) and 4 weeks (visit 2)
|
The change in airway reactivity measured prior to and after 4 weeks of either CPAP or SHAM treatment.
Methacholine bronchial challenge was performed using the 5-breath protocol (DeVilbiss646 with KoKo dosimeter: 9 μL/breath) with quadrupling concentrations starting with 0.0625 mg/mL and continuing until FEV1 decreased by 20% (PC20) or Methacholine concentration of 16 mg/mL was inhaled.
|
baseline (visit 1) and 4 weeks (visit 2)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Airway Inflammation From Baseline (Visit 1) and 4 Weeks (Visit 2)
大体时间：baseline (visit 1) and 4 weeks (visit 2)
|
Airway Inflammation assessed as the change in the percentage eosinophils in the induced sputum measured prior to and after 4 weeks of Continuous Positive Airway Pressure (CPAP) or sham CPAP treatment.
|
baseline (visit 1) and 4 weeks (visit 2)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Robert Tepper, MD、Indiana University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年1月1日
初级完成 (实际的)
2020年1月9日
研究完成 (实际的)
2020年1月9日
研究注册日期
首次提交
2015年3月18日
首先提交符合 QC 标准的
2015年3月23日
首次发布 (估计)
2015年3月24日
研究记录更新
最后更新发布 (实际的)
2021年3月9日
上次提交的符合 QC 标准的更新
2021年2月17日
最后验证
2021年2月1日
更多信息
与本研究相关的术语
其他研究编号
- 4689673
- 5R01HL048522 (美国 NIH 拨款/合同)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.