Concentration of Itraconazole Solution in Nasal Secretions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Concentration of Itraconazole in nasal secretions at 7 days
研究概览
简要总结
The primary objective of this study is to determine the concentration of itraconazole irrigation in nasal mucous specimens via collection and High-performance liquid chromatography (HPLC) assay.
Eight (8) patients with chronic rhinosinusitis (CRS) and two (2) healthy controls will be enrolled in the initial evaluation. After an initial control nasal specimen, followed by seven days of twice daily topical itraconazole irrigation, nasal specimens will be collected at varying time intervals and the concentrations measured.
The primary endpoint is development of a reliable collection and assay technique with concentration curves over time of topically administered itraconazole. A secondary endpoint is to determine if the concentrations measured achieve a mean inhibitory concentration (MIC90) to commonly cultured fungal species in the nose.
详细描述
This is a pilot study for the purpose of gathering concentration data on a commonly used topical antifungal solution of itraconazole. CRS patients that meet the defined inclusion criteria will begin topical itraconazole antifungal irrigations on Day 1. This will consist of Itraconazole in Sterile Water 100 mg/1000 ml, irrigating each nostril with 20 ml of solution twice daily, with a bulb syringe as directed. The patient will return on Day 7 for repeat examination and nasal secretion collection. Two patients will be randomly selected to have blood drawn at the completion of day 7 testing to determine the concentration of itraconazole in the blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than or equal to eighteen years of age.
- •Patient must be willing to be available and comply with all scheduled procedures as defined in the protocol.
- •Patients that have been felt to be candidates for topical itraconazole therapy and would have been started on the therapy regardless of study inclusion
- •CRS defined by American Academy of Otolaryngology - Head and Neck Surgery (AAO HNS) guidelines
- •Do not meet CRS definitions. No acute sinusitis within past 4 weeks. No previous surgery for rhinosinusitis. No history of allergic rhinitis or other rhinologic disorders.
排除标准
- •Previous use of a topical antifungal nasal irrigation within the past 2 weeks or a systemic antifungal medication within the past 3 months.
- •History of cystic fibrosis, immunodeficiency, immotile cilia syndrome, clinical or radiographic suspicion for fungal mycetoma or invasive fungal sinusitis
- •Pregnancy - female patients of child bearing age will undergo a pregnancy test, if positive they will be excluded
- •History of liver disease
- •History of congestive heart failure
- •Allergy or sensitivity to itraconazole, or other azole antifungals, or any other ingredient in the preparation.
研究组 & 干预措施
Itraconazole
Topical application of Itraconazole in Sterile Water 100 mg/1000 ml, irrigating each nostril with 20 ml of solution twice daily for 7 days.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Concentration of Itraconazole in nasal secretions at 7 days
时间窗: 7 days after initiation of study
次要结局
未报告次要终点