A Pilot Investigation of the Nasal Mucosal Absorption, Retention, and Metabolism of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray When Each Formulation Is Administered to Currently Symptomatic Patients (18 Years or Older) With Documented Perennial Allergic Rhinitis (PAR).
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- levels of ciclesonide in biopsy tissue
研究概览
简要总结
The purpose of this study is to measure the amount of a nasal steroid spray (ciclesonide) absorbed by the tissue in the nose 2 hours after having this study drug sprayed in the nose
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Males and females 18 years of age or older.
- •History of perennial allergic rhinitis for at least 1 year prior to screening.
- •Positive skin test to perennial allergen.
排除标准
- •Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- •Pregnant or lactating women.
- •Upper respiratory infection within 14 days of study start.
- •Active asthma requiring treatment with inhaled or systemic steroids.
- •Use of any form of nasal spray during the previous month.
研究组 & 干预措施
1
placebo in left nostril, isotonic ciclesonide in right
干预措施: placebo, isotonic ciclesonide, hypotonic ciclesonide (Drug)
2
hypotonic ciclesonide in left nostril, placebo in right
干预措施: placebo, isotonic ciclesonide, hypotonic ciclesonide (Drug)
3
hypotonic ciclesonide in right and left nostrils
干预措施: placebo, isotonic ciclesonide, hypotonic ciclesonide (Drug)
4
isotonic ciclesonide in both right and left nostrils
干预措施: placebo, isotonic ciclesonide, hypotonic ciclesonide (Drug)
6
placebo in both right and left nostrils
干预措施: placebo, isotonic ciclesonide, hypotonic ciclesonide (Drug)
5
isotonic ciclesonide in left nostril and hypotonic ciclesonide in right
干预措施: placebo, isotonic ciclesonide, hypotonic ciclesonide (Drug)
结局指标
主要结局
levels of ciclesonide in biopsy tissue
时间窗: 2 hours post study drug administration
次要结局
未报告次要终点
