EUCTR2005-005622-31-GB进行中（未招募）1 期
A Proof Of Concept Study To Investigate The Potential Role Of Acetylsalicyclic Acid (Aspirin) As An Anti-Inflammatory Agent For The Treatment Of Asthma - Aspirin as an anti-inflammatory agent in the treatment of asthma
niversity of Dundee0 个研究点目标入组 20 人开始时间: 2006年1月13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.Informed consent
- •2.Mild to moderate persistent stable asthma with an FEV1 of >60% of predicted
- •3.Males or females aged 18-65
- •4.A documented MCh PC10 of less than 4mg/ml at visit 1
- •5.Known tolerance to systemic NSAID treatment
- •6.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.Daily requirement of >800mg BDP or equivalent of ICS
- •2.Instability of control after or during ICS withdrawal, or after withdrawal of second line agents
- •3.Known or suspected hypersensitivity to any of the IMP’s in particular NSAID intolerance
- •4.Previous or current history (suggestive or definite) of upper gastro-intestinal bleeding or peptic ulcer disease
- •5.Use of oral corticosteroids within the last 3 months
- •6.A respiratory tract infection within the last 2 months
- •7.Any concomitant medical condition that may either endanger the safety of the participant, or compromise the trial protocol. This can include significantly abnormal screening blood test results.
- •8.Pregnancy, planned pregnancy or lactation
- •9.Current treatment with aspirin or non-steroidal anti-inflammatory medication.
研究者
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