跳至主要内容
临床试验/EUCTR2013-003269-33-BG
EUCTR2013-003269-33-BG进行中(未招募)1 期

A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects with Inadequately Controlled, Severe Asthma

MedImmune LLC0 个研究点目标入组 552 人开始时间: 2014年2月24日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
MedImmune LLC
入组人数
552

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Age and weight range as defined in the protocol.
  • Documented Physician-diagnosed asthma in line with the protocol requirements.
  • Subjects must have received a physician-prescribed asthma controller
  • regimen as outlined in the protocol.
  • Able to meet the pulmonary function requirements and other defined asthma metrics/measures as outlined in the study protocol.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 510
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 42

排除标准

  • Established diagnosis of occupational asthma.
  • Current smokers or subjects with a smoking history of = 10 pack years.
  • Any concomitant respiratory disease, including acute upper or lower respiratory infections.
  • Known history of active tuberculosis (TB).
  • Receipt of any marketed or investigational biologic agent within 4 months or 5 half lives prior to Visit 1 (Week 5), whichever is longer.

研究者

发起方
MedImmune LLC

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