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临床试验/EUCTR2005-004475-37-GB
EUCTR2005-004475-37-GB进行中(未招募)1 期

Comparative study of the bioactivity of the HFA Fluticasone Dipropionate via current delivery devices - Systemic bioactivity of fluticasone via current delivery devices. Ver 1

niversity of Dundee ( Research & Innovation Services)0 个研究点目标入组 20 人开始时间: 2005年10月31日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
20

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

  • 1.Mild to moderate stable asthmatics on =800µg BDP or equivalent
  • 2.Male or female 18-65
  • 3.Informed Consent
  • 4.Ability to comply with the requirements of the 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
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1.Severe asthmatics as defined by an FEV1= 60% or PEF variability > 30% or
  • with continual daytime or nocturnal symptoms.
  • 2.The use of oral corticosteroids within the last 3 months.
  • 3.Recent respiratory tract infection (2 months).
  • 4.Significant concomitant respiratory disease such as COPD, CF, ABPA,
  • bronchiectasis and active pulmonary tuberculosis.
  • 5.Any other clinically significant medical condition such as unstable angina,
  • acute myocardial infarction in the preceding 3 months, recent TIA/
  • CVA, that may endanger the health or safety of the participant, or
  • jeopardise the protocol.
  • 6.Any significant abnormal laboratory result as deemed by the investigators
  • 7.Pregnancy, planned pregnancy or lactation
  • 8.Known or suspected contra-indication to any of the IMP’s
  • 9.Concomitant use of medicines (prescribed, over the counter or herbal) that
  • may interfere with the trial

研究者

发起方
niversity of Dundee ( Research & Innovation Services)

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