Modulation Of Airway Reactivity With Chronic Mechanical Strain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change in Airway Reactivity From Baseline (Visit 1) and 4 Weeks (Visit 2)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change in Airway Reactivity From Baseline (Visit 1) and 4 Weeks (Visit 2)
时间窗: 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.
次要结局
- Change in Airway Inflammation From Baseline (Visit 1) and 4 Weeks (Visit 2)(baseline (visit 1) and 4 weeks (visit 2))
研究者
Robert Tepper
Robert Tepper
Indiana University