Evaluation of Regional Lung Deposition of Inhaled Saline Using the Trans-Nasal Pulmonary Aerosol Delivery Device in Healthy, Non-Smoking Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- 24-hour clearance fraction
研究概览
简要总结
Purpose: Characterize the depositional attributes of a specialized trans-nasal aerosol delivery device in healthy people using clinical measurements of mucociliary clearance.
Procedures (methods): 14% hypertonic saline (HS) aerosol containing the radio tracer Tc99m-sulfur colloid will be delivered via the tPAD and compared to the well characterized PARI LC Star nebulizer (7% HS) using planar gamma scintigraphy (i.e. particle clearance). The fraction of sulfur colloid particles that clear over the ensuing 24 hours with each device will indicate the fraction deposited in conducting airways.
详细描述
Purpose: This is an early device characterization study to define the fraction of delivered aerosol generated by a novel nebulizer (tPAD) that deposits in conducting airways.
Design: Open label, cross-over design, using a standard oral nebulizer (PARI LC Star) as a comparator. The order of visits will be randomized.
Methods: Gamma scintigraphy will be performed following use of each device on separate study visits.
Primary Outcome: Fraction of inhaled particles that clears over 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- None
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
- 是
入选标准
- •Subjects aged 18 to 65 years (inclusive), and with a body mass index (BMI) < 30 kg/m
- •Non-pregnant female subjects must be either not sexually active, post-menopausal, surgically sterilized, or agree to use an appropriate "double-barrier" method (such as a diaphragm and condom); or, must currently be using a prescribed transdermal, injection, implant, or oral contraceptive during study participation.
- •Subjects who are in good health, as determined by a medical history and examination.
- •Subjects who have normal lung function with a FEV1 ≥80% predicted and a FEV1/FVC >70%.
- •Subjects who are capable of providing written informed consent in English to participate in the study.
排除标准
- •Subjects who have evidence of an upper or lower respiratory infection or clinically significant illness at entry or within 14 days of the start of dosing.
- •Subjects with lung diseases as defined by a FEV1 <80% or a FEV1/FVC <70%
- •Subjects on inhaled medications, such as short or long acting bronchodilators or inhaled corticosteroids, will be excluded.
- •Subjects with a history of allergy or intolerance to albuterol or hypertonic saline.
- •Subjects with active chronic or acute rhinosinusitis or other nasal or sinus abnormality or disease.
- •Subjects who have a present history of any clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological disorder or disease, substance abuse, or any other major disorder or disease.
- •Subjects who have had radiation exposure within the past year that would cause them to exceed Federal Regulations of 15 Rem annually by participating in this study. The study team will determine this.
- •Subjects with a history of smoking within the last 3 months.
- •Subjects with a positive pregnancy test or who are pregnant or are nursing.
- •Subjects who, in the opinion of the Principal Investigator, should not participate in the study.
- •Subjects with a BMI >30 kg/m2
- •Subjects who are taller than Height >6'2"
- •Subjects who have facial hair that they are not willing to shave
研究组 & 干预措施
tPAD, then PARI LC Star Nebulizer
tPAD device delivering 14% HS labelled with technetium-99m sulfur colloid particles separated by 2-28 days and then PARI LC delivering 7% HS labeled with technetium-99m sulfur colloid particles.
干预措施: tPAD Device (Device)
tPAD, then PARI LC Star Nebulizer
tPAD device delivering 14% HS labelled with technetium-99m sulfur colloid particles separated by 2-28 days and then PARI LC delivering 7% HS labeled with technetium-99m sulfur colloid particles.
干预措施: PARI LC Star Nebulizer (Device)
PARI LC Star Nebulizer, then tPAD
PARI LC delivering 7% HS labelled with technetium-99m sulfur colloid particles separated by 2-28 days and then tPAD device delivering 14% HS labelled with technetium-99m sulfur colloid particles
干预措施: tPAD Device (Device)
PARI LC Star Nebulizer, then tPAD
PARI LC delivering 7% HS labelled with technetium-99m sulfur colloid particles separated by 2-28 days and then tPAD device delivering 14% HS labelled with technetium-99m sulfur colloid particles
干预措施: PARI LC Star Nebulizer (Device)
结局指标
主要结局
24-hour clearance fraction
时间窗: 24 hours
The percentage of initially deposited aerosol particles that clear over 24 hours will be measured with gamma scintigraphy after 24 hours
次要结局
- Central:Peripheral Deposition Ratio(0-4 minutes after deposition)