STUDY OF BUDESONIDE NEBULIZING SUSPENSION & PLACEBO IN ASTHMATIC CHILDREN

布地奈德雾化混悬剂的研究

• 批准号: 6120788
• 负责人: LYNDA C SCHNEIDER
• 金额: $ 3.04万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6120788
• 关键词: asthma; bronchodilators; child (0-11); clinical research; clinical trials; dosage forms; drug screening /evaluation; glucocorticoids; hormone therapy; human subject; human therapy evaluation; hypothalamic pituitary adrenal axis; pediatric pharmacology; respiratory disorder chemotherapy; respiratory function

The study will evaluate the efficacy and safety of budesonide nebulizing suspension, in children between the ages of 6 months and 8 years with moderate to severe asthma. The trial is a double blind placebo- controlled, dosage, efficacy and safety trial. During the course of treatment, patients will be evaluated with pulmonary function tests and screening laboratory studies. Additionally, assessment of hypothalamic-pituitary-adrenal axis function will be done with baseline laboratory studies, including Cortosyn stimulation testing.

本研究将评价布地奈德雾化吸入的有效性和安全性 6个月至8岁儿童， 中度至重度哮喘。试验是双盲安慰剂试验- 对照、剂量、疗效和安全性试验。过程中 治疗期间，将对患者进行肺功能检查， 筛选实验室研究。 此外，下丘脑-垂体-肾上腺轴功能评估 将进行基线实验室研究，包括Cortosyn 刺激试验