跳至主要内容
临床试验/NCT00461812
NCT00461812终止4 期

A Single-Blind, Randomized, Positive-controlled Study to Compare Monotherapy With an Inhaled Corticosteroid (Mometasone) to Combination Therapy With an Inhaled Corticosteroid + a Long-Acting Bronchodilator (Advair) in Patients With Milder Persistent Asthma

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2007年4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
终止
入组人数
33
试验地点
1
主要终点
Efficacy as Assessed my Pulmonary Function Tests

研究概览

简要总结

The research hypothesis for the proposed study asks the question, can Asmanex® demonstrate comparable anti-inflammatory therapeutic efficacy to the combination product, Advair® in control of mild persistent asthma?

The purpose is to demonstrate that the anti-inflammatory protection afforded by monotherapy with an inhaled steroid (Asmanex®) is comparable to combination therapy with Advair® 100/50, when measured by this standard methodology (methacholine bronchoprovocation) in subjects with mild persistent asthma.

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
Single

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

  • subjects 18 to 65 years of age
  • a >2 year history of asthma
  • FEV1 > 80% for subjects currently using Advair®.

排除标准

  • severe asthma
  • current smokers
  • pregnant or breast-feeding women
  • other chronic significant illnesses

研究组 & 干预措施

Mometasone

Experimental

干预措施: Mometasone (Drug)

Advair

Experimental

干预措施: Advair (Drug)

结局指标

主要结局

Efficacy as Assessed my Pulmonary Function Tests

时间窗: change from baseline to study completion

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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