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临床试验/NCT00793858
NCT00793858撤回4 期

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).

University of Chicago1 个研究点 分布在 1 个国家开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

placebo in left nostril, isotonic ciclesonide in right

干预措施: placebo, isotonic ciclesonide, hypotonic ciclesonide (Drug)

2

Active Comparator

hypotonic ciclesonide in left nostril, placebo in right

干预措施: placebo, isotonic ciclesonide, hypotonic ciclesonide (Drug)

3

Active Comparator

hypotonic ciclesonide in right and left nostrils

干预措施: placebo, isotonic ciclesonide, hypotonic ciclesonide (Drug)

4

Active Comparator

isotonic ciclesonide in both right and left nostrils

干预措施: placebo, isotonic ciclesonide, hypotonic ciclesonide (Drug)

6

Placebo Comparator

placebo in both right and left nostrils

干预措施: placebo, isotonic ciclesonide, hypotonic ciclesonide (Drug)

5

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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