EUCTR2012-003923-39-GB进行中（未招募）1 期
Pilot study to evaluate whether treating persistent small airway dysfunction with extra-fine HFA-Beclometasone results in improved asthma control. - Targeted small airways therapy in persistent asthma ANDA3
Tayside Medical Science Centre0 个研究点目标入组 74 人开始时间: 2013年6月3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
- 74
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
入选标准
- •Male and female volunteers aged 18-65, with persistent asthma.
- •Asthma Control Questionnaire score >1.0 (at end of run-in)
- •Spirometry: FEV1 >60% predicted.
- •Impulse oscillometry: R5>130% predicted and R5-R20>0.03kPa/L/s.
- •Ability to perform spirometry, IOS, bronchial challenge and all domiciliary measurements.
- •Ability to give informed consent.
- •Asthmatic patients receiving treatment at Step 2, 3, or 4 of BTS asthma guidelines.
- •Ability to withhold long acting beta 2 agonists for the duration of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 23
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Pregnancy or lactation.
- •Known or suspected sensitivity to the IMP(s).
- •Inability to comply with protocol.
- •Any clinically significant medical conditions that may either endanger the health or safety of the participant, or jeopardise the protocol.
- •An asthma exacerbation requiring systemic steroid therapy or lower respiratory tract infection requiring antibiotics within 3 months prior to study commencement.
- •Participation in previous trial within 30 days.
研究者
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