ISRCTN14101933终止未知
A pragmatic, off-label, randomised controlled trial of variable inhaled corticosteroid dosing by blood eosinophil level and medication adherence digital evaluation in airways disease
niversity of Leicester0 个研究点目标入组 760 人开始时间: 2022年9月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 760
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Clinically diagnosed airway disease (asthma or COPD)
- •2. Blood eosinophil count of = 0.2 x 109/L either at the clinic visit or any one time in the preceding 24 months
- •3. History of Exacerbation prone airway disease” (defined as 2 or more exacerbations requiring oral corticosteroids and or antibiotics within 12 months of initial pre-screening review)
- •4. Male and female patients aged 18 years and over
- •5. Willing and able to consent to participate in trial
- •6. Able to use a smartphone device and comply with biomarker guided protocol
排除标准
- •1. Unable to give informed consent
- •2. Unable to use a smartphone device and or comply with biomarker guided protocol
- •3. Absence of eosinophilia (defined as persistently < 0.2 x 109 cells/L withing the last 24 months)
- •4. History of unstable or severe cardiac, hepatic, thyrotoxicosis, or renal disease, or other medically significant illness which the investigator believes would be a contraindication to study participation
- •5. Current or within the last 6 months (or maximum relevant wash out period, whichever is longer), participation in an investigational medicinal product (IMP) or device trial at the time of screening
- •6. History of long QT syndrome or whose QTcF interval (Fridericia’s) is prolonged >450 msec at screening or baseline
- •7. History of previous hospital admission as pneumoniaa (with radiological lung changes) prior to 12 months of study screening
- •8. History of human immunodeficiency virus (HIV) or hepatitis B or C
- •9. History of active Malignancy in any organ system (diagnosis within last 12 months or ongoing active cancer treatment such as chemotherapy, radiotherapy, or immunotherapy
- •10. Patients whose treatment is considered palliative (life expectancy < 6 months).
- •11. Pregnancy/lactating or intends to become pregnant during the study period where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test in urine or serum
- •12. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, who are not able to use effective methods of contraception during dosing of trial treatment and for a minimum of 1 month after their last treatment
- •13. Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening including (but not limited to):
- •13.1. AST or ALT >2.0x upper limit of normal (ULN)
- •13.2. Total bilirubin >1.3 X ULN at screening (except for patients with Gilberts syndrome where suitability for inclusion will be left to the discretion of the local investigator)
研究者
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