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临床试验/NCT00305487
NCT00305487已完成3 期

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Efficacy of Ciclesonide (200mcg and 100mcg, Once Daily) Applied as a Nasal Spray for Two Weeks in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 6 to 11 Years of Age

AstraZeneca72 个研究点 分布在 1 个国家目标入组 660 人开始时间: 2006年3月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
AstraZeneca
入组人数
660
试验地点
72
主要终点
Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment

研究概览

简要总结

The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a treatment period (2 weeks).

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
Double

入排标准

年龄范围
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Main Inclusion Criteria:
  • Written informed consent
  • General good health other than seasonal allergic rhinitis
  • Positive standard skin prick test

排除标准

  • Pregnancy, nursing, or plans to become pregnant or donate gametes for in vitro fertilization
  • Participation in any investigational drug trial within the 30 days preceding the Screening Visit
  • A known hypersensitivity to any corticosteroid or any of the ingredients in the study drug formulation
  • Plans to travel outside the study area (the known pollen area for the investigative site) for 24 hours or more during the final 7 days of the baseline period
  • Plans to travel outside the study area (the known pollen area for the investigative site) for more than 2 consecutive days OR more than 3 days total during the treatment period
  • Use of any prohibited concomitant medications
  • Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit
  • Use of antiepileptic drugs for epilepsy within 30 days of the Screening Visit
  • Study participation by more than one patient from the same household

结局指标

主要结局

Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment

次要结局

  • Physician assessment of nasal symptoms score at endpoint
  • safety
  • average of morning and evening parent/caregiver reported instantaneous total nasal symptom score over the two weeks of treatment

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (72)

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