EUCTR2013-005365-39-GB进行中（未招募）1 期
A guideline approach to therapy step-down utilising Flutiform®: change and step-down (FFLU-X study) - Flutiform® Change and Step-Down Study (FFLU-X study) v.1.0
Research in Real-Life Ltd0 个研究点目标入组 224 人开始时间: 2014年2月5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
- 224
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
- •To be included in phase 1 of the study, all of the criteria below need to be met:
- •1) Able and willing to provide written informed consent and to comply with the study protocol
- •2) Current diagnosis of asthma (as evidenced by appropriate diagnostic code)
- •3) Step 4 of the BTS guidelines
- •4) Received at least 4 inhalers of Seretide® 250 Evohaler® 2 puffs twice daily in the last 6 months (corresponds to =66% compliance)
- •5) No asthma exacerbation* in last 3 months
- •6) =2 exacerbations* in last 12 months
- •7) No critical errors in device use after training (during baseline visit)
- •8) Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after discontinuation of study drug. Acceptable methods of contraception include intrauterine device (IUD) known to have a failure rate of less than 1% per year, steroidal contraceptive (oral, implanted, transdermal, or injected), barrier method with spermicide, abstinence, and partner vasectomy.
- •* Exacerbation defined as acute course of oral steroids, emergency room attendance and/or hospitalisation for asthma
- •Only patients who received Flutiform and did not have any exacerbations in phase 1 will be eligible for phase 2 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 164
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1) Chronic respiratory disease other than asthma
- •2) Uncontrolled asthma (according to the Global Initiative for Asthma (GINA) criteria)
- •3) Participation in a clinical study within the past year
- •4) Hypersensitivity to Flutiform®, its component Formoterol or its excipients
- •5) Pregnancy
研究者
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