Evaluation of Ventilation Defects Downstream of Mucus Plugs in Patients With Muco-Obstructive Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Ventilation Defect in Mucus blocked Regions
研究概览
简要总结
In this study, xenon MRI will be used to evaluate regional functional consequences of mucus plugs in the lungs of patients with muco-obstructive pulmonary disease. Mucus plugs will be identified using CT imaging, and xenon MRI will be used to evaluate ventilation and gas exchange impairments in regions of the lungs corresponding to the airways downstream of mucus plugs.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adequate completion of informed consent process with written documentation
- •Patients 18 - 65 years old
- •• Physician diagnosis of muco-obstructive pulmonary disease, including cystic fibrosis, severe asthma, chronic obstructive pulmonary disease, or non-cystic fibrosis bronchiectasis for > 1 year
- •Able to perform reproducible spirometry according to ATS criteria based on clinical PFTs.
排除标准
- •Respiratory tract infection within the 4 weeks prior to Visit 1
- •Body mass index (BMI) > 30 at Visit 1
- •One-time doses such as intra-articular injections require a 4-week washout prior to Visit 1
- •ER visit related to pulmonary condition within the previous 4 weeks of Visit 1
- •Significant concomitant medical illness, including (but not limited to) heart disease, cancer, uncontrolled diabetes, other chronic lung diseases (determined by the Investigator.)
- •Resting O2 saturation <90% with maximum supplemental O2 delivered by nasal canula
- •Positive urine pregnancy test
- •Participation in an intervention study (including bronchoscopy) or use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study
- •Unable or unlikely to complete study assessments in the opinion of the Investigator
- •Study intervention poses undue risk to patient in the opinion of the Investigator
- •Conditions that will prohibit MRI scanning determined by the MRI safety screening.
结局指标
主要结局
Ventilation Defect in Mucus blocked Regions
时间窗: Baseline
The primary endpoint of this study is the ventilation defect percent (VDP; measured by Xe-MRI) in regions of the lungs that are downstream of mucus plugs (identified on CT imaging).
Ventilation Defect in Mucus blocked Regions
时间窗: 12-weeks
The primary endpoint of this study is the ventilation defect percent (VDP; measured by Xe-MRI) in regions of the lungs that are downstream of mucus plugs (identified on CT imaging).
次要结局
- Changes to Gas Exchange with Bronchodilator(Baseline)
- Long term change in VDP(12-weeks)
- Change in VDP(4-weeks)