临床试验/NCT00641914

NCT00641914已完成4 期

Inhaled Steroid Treatment As Regular Therapy in Early Asthma. A Study on the Effect of Early Intervention With Long-Term Inhaled Budesonide (Pulmicort Turbuhaler ® ) in Newly Diagnosed Asthma.

AstraZeneca0 个研究点目标入组 6,800 人开始时间: 1996年10月最近更新: 2009年3月25日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: AstraZeneca
入组人数: 6,800
主要终点: Severe asthma related events (SARE) (part A); post-bronchodilator FEV1 % of predicted normal (part B)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

A study of the effect of the early treatment with Pulmicort of newly diagnosed asthma. Patients will receive either Pulmicort or a non-active treatment for three years. Neither patients or investigators will be aware of the treatment received. After three years of treatment all patients will receive Pulmicort for 2 further years.

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 60 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male or female patients aged between 6 and 60 years
•diagnosed with asthma within 2 years of starting the study
•Ability to use a Turbuhaler

排除标准

•Symptoms indicating asthma (e.g. wheezing) for more than two years prior to starting the study
•A history of the use of treatments like Pulmicort for more than 30 days per year in the two years before starting the study
•Regular daily treatment for asthma for more than two years before starting the study

研究组 & 干预措施

1

Experimental

干预措施: budesonide (Drug)

2

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Severe asthma related events (SARE) (part A); post-bronchodilator FEV1 % of predicted normal (part B)

时间窗: At week 6 and12, and every 3 months thereafter

次要结局

Pre-bronchodilator FEV1 % of predicted normal(At week 6 and12, and every 3 months thereafter)
HE: Asthma related events and health care utilisation, and symptom free days (SFD)(At week 6 and12, and every 3 months thereafter)
Post-bronchodilator FVC % of predicted(At week 6 and12, and every 3 months thereafter)

研究者

发起方

AstraZeneca

申办方类型

Industry

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