The Effect of Budesonide Spray Via Mucosal Atomization Device on the Hypothalamic-Pituitary Axis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Cosyntropin testing and blood work for quantification of plasma budesonide and plasma cortisol.
研究概览
简要总结
Budesonide, a steroid subtype, has been used as an adjunctive treatment for chronic rhinosinusitis as a topical nasal steroid spray. The current standard of care at St. Paul's Sinus Centre is to administer budesonide via the Mucosal Atomization Device (MAD). It is believed that the MAD is a better device than the standard nasal lavage because its fine mist enhances absorption and improves bioavailability. No studies have been done to determine if enhanced absorption and improved bioavailability of budesonide via MAD could potentially affect the hypothalamic-pituitary-adrenal (HPA) axis, resulting in the suppression of our own body's production of natural steroids.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years of age or older
- •Diagnosed with CRS with or without polyps
- •Awaiting for Functional Endoscopic Sinus Surgery
- •Give consent on their own
排除标准
- •Concurrent or recent use (within the past 30 days) of systemic corticosteroids
- •History of pituitary disease
- •Morbid obesity (body mass index [calculated as weight in kilograms divided by height in meters squared]
- •Concurrent or recent use of medications that accelerate the clearance of cortisol:
- •o Such as dilantin, rifampin, amphetamines, or lithium carbonate
- •Concurrent use of medications that interfere with the production of cortisol:
- •o Such as ketoconazole, amphotericin B, bupropion, Echinacea, fluoroquinolones, itraconazole, licorice
- •Use of oral contraception
- •Use of female or male hormone therapy
- •Known hypersensitivity to cortisol, corticotropin, or cosyntropin
结局指标
主要结局
Cosyntropin testing and blood work for quantification of plasma budesonide and plasma cortisol.
时间窗: Participants will be followed for 30 days.
次要结局
- SNOT-22 questionnaire to measure subjective perspective.(Participants will be followed for the duration of post op standard of care, an expected average of 6 months.)
研究者
Amin Javer
MD FRCSC FARS, Principal Investigator, Director of St Paul's Sinus Centre
St. Paul's Hospital, Canada