Study to Assess the Impact of Inhaled Silver Nanoparticles on Lung Cell Immune Response
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- To evaluate the impact of nanosilver exposure on ex vivo inflammatory response of bronchoscopy-derived cells (i.e. alveolar macrophage and epithelial cells) to challenge with a TLR agonist
研究概览
简要总结
Background:
- Nanosilver is tiny silver particles. Many products contain nanosilver, like antimicrobial cleaning supplies and antimicrobial fabrics. Some products also contain nanosilver in a solution that people inhale. The companies that make these products claim they can help boost the immune system.
Objective:
- To learn if inhaling nanosilver affects the lung s immune system. In addition, to see if nanosilver affects lung function and if it gets absorbed into the bloodstream after it is inhaled.
Eligibility:
- Healthy, non-smoking adults ages 18 60.
Design:
- Participants will be pre-screened by phone.
- Participants will then be screened with a medical history and physical exam. They will give blood and urine samples.
- Participants will have lung function tests. They will breathe into a spirometer. It has a mouthpiece attached to a tube that is connected to a computer.
- Participants will have a methacholine challenge test. They will blow into a spirometer. Then they will inhale methacholine.
- Eligible participants will have 3 study visits over 2 5 weeks. At each visit, they will repeat some of the screening tests.
- At visit 1, participants will have a bronchoscopy. For this, an intravenous line is placed in an arm vein. Electrodes are placed on the chest. A tube is placed through the nose and into the airways. The airway is washed. A sample of cells is taken.
- At visit 2, participants will get the study treatment. They will inhale a nanosilver solution mist. They will have lung function tests before and after treatment.
- Participants will collect their urine from the time they get the treatment until they return to the clinic the next day.
- At visit 3, participants will turn in their urine. They will have another bronchoscopy.
详细描述
This is a single-center, single-arm pilot study to assess the impact of inhaled silver nanoparticles (nanosilver or nAg) on immune responses in the lung. Non-smoking, healthy adults (no lung or cardiovascular conditions), age 18-60 will be recruited to participate; pregnant or breastfeeding women will be excluded.
Potential participants will be prescreened by telephone and scheduled for a final eligibility visit that will include vital signs/anthropometry, medical/medication history review, physical exam, urine tests, blood draw, urine collection, and pulmonary function tests (PFTs; i.e., spirometry and methacholine challenge test). After eligibility is confirmed, the participant will be scheduled for a baseline visit, which includes vital signs/anthropometry, medical/medication history review, physical exam, blood draw, urine collection, and bronchoscopy (with lavage and brushing). Participants will return 14-40 days between the baseline visit and study treatment visit, which includes vital signs/anthropometry, blood draw, urine collection, spirometry, one-time administration of ionic silver via nebulizer, and instructions to collect urine for 24 hours. The next day after the study treatment visit, the participant will return for a visit that includes vital signs/anthropometry, blood draw, providing the 24-hour urine sample, spirometry, and bronchoscopy. During each bronchoscopy procedure, bronchoalveolar lavage (BAL) fluid and tissue from bronchial brushings will be collected from the participant to obtain alveolar macrophages and bronchial epithelial cells.
The primary objective of the study is to determine whether exposure to nanosilver alters the immune responses of lung cells. The primary laboratory analysis will determine whether exposure to nanosilver mediates a change from baseline in the response of bronchoscopy-derived, cultured macrophages or epithelial cells to challenge with a toll-like receptor (TLR) agonist. Additional analyses will assess changes in cytokine levels in BAL fluid, changes in the lung microbiome, silver penetration into the blood stream, silver excretion in the urine, and changes in PFT measures.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To evaluate the impact of nanosilver exposure on ex vivo inflammatory response of bronchoscopy-derived cells (i.e. alveolar macrophage and epithelial cells) to challenge with a TLR agonist
时间窗: 1 day post treatment
次要结局
未报告次要终点