ISRCTN74240789进行中（未招募）Unknown
CONTENTed study: Characterisation Of Neuroimaging and wellbeing over Time in severe EosiNophilic asthma Treated with mepolizumab
orth Bristol NHS Trust0 个研究点目标入组 150 人开始时间: 2023年12月4日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Aged 18+ years
- •2. Physician-diagnosed severe eosinophilic asthma eligible for mepolizumab therapy as per National Institute for Health and Care Excellence guidance 2017, satisfying one of the following criteria:
- •2.1. Peripheral blood eosinophils =300 cells per microlitre, with =4 exacerbations requiring oral corticosteroids in the previous 12 months or continuous oral corticosteroids of at least the equivalent of prednisolone 5 milligrams per day over the previous 6 months
- •2.2. Peripheral blood eosinophils =400 cells per microlitre, with =3 exacerbations requiring oral corticosteroids in the previous 12 months or continuous oral corticosteroids of at least the equivalent of prednisolone 5 milligrams per day over the previous 6 months
- •3. A regional asthma MDT decision was made to start mepolizumab
- •4. The patient agrees to start mepolizumab and is able to provide written informed consent and participate in the study
- •1. Aged 18+
- •2. Physician-diagnosed mild or moderate asthma for >3 months, GINA step 2-4
- •3. Well-controlled asthma defined by an Asthma Control Questionnaire–5 (ACQ-5) =/< 1.5
- •4. Participant is willing and able to give informed consent to take part in the study
排除标准
- •1. Current smoking, or a greater than 10 pack-year history of smoking in ex-smokers.
- •2. A diagnosis of an alternative lung disease, including, but not limited to, allergic bronchopulmonary aspergillosis, eosinophilic granulomatous polyangiitis, bronchiectasis or chronic obstructive pulmonary disease.
- •3. Previous anti-asthma biological therapies including mepolizumab, benralizumab, omalizumab, reslizumab and dupilimab.
- •4. Pregnancy/childbearing age not using contraception.
- •5. Alcohol and drug addiction.
- •6. CNS diseases the investigators consider would have a significant effect on outcomes – including stroke, MS, epilepsy, tumour or significant cognitive impairment (including dementia, or severe learning disabilities).
- •7. Participants with contraindications to MRI will not be able to take part in the MRI study, but can be recruited to complete the questionnaires.
- •8. Contraindications to completing pulmonary function tests.
- •1. Oral corticosteroid use in the last 3 months, or =3 oral corticosteroid courses in the last 12 months.
- •2. Current smoking, or a greater than 10 pack-year history of smoking in ex-smokers.
- •3. A diagnosis of an alternative lung disease, including, but not limited to, allergic bronchopulmonary aspergillosis, eosinophilic granulomatous polyangiitis, bronchiectasis, chronic obstructive pulmonary disease or interstitial lung disease.
- •4. Previous anti-asthma biological therapies including mepolizumab, benralizumab, omalizumab, reslizumab, dupilumab or tezepelumab.
- •5. Pregnancy/childbearing age not using contraception.
- •6. Alcohol and drug addiction.
- •7. CNS diseases the investigators consider would have a significant effect on outcomes – including stroke, MS, epilepsy, tumour or significant cognitive impairment (including dementia, or severe learning disabilities).
- •8. Participants with contraindications to MRI will not be able to take part in the MRI study, but can be recruited to complete the questionnaires.
- •9. Contraindications to completing pulmonary function tests.
研究者
相似试验
招募中
不适用
An observational neuroimaging and neurophysiological study investigating the visual pathway in Huntington*s disease.hereditary neurodegenerative movement disorderHuntington's disease1002929910028037NL-OMON45518eids Universitair Medisch Centrum60
已完成
不适用
Translating neuroimaging findings from research into clinical practice (PSYSCAN): Clinical High Riskhigh risk of psychosis10039628schizophreniaNL-OMON47887Institute of Psychiatry, King's College, London74
尚未招募
不适用
Brain science of chronic pain using PET and MRIfibromyalgia, chronic low back pain, postherpetic neuralgia, other chronic pain disordersJPRN-UMIN000040403The Jikei University School of Medicine80
尚未招募
Unknown
Research on neurological disease using neuroimaging database and movement analysisJPRN-UMIN000053240Tokyo Medical and Dental University800
进行中（未招募）
1 期
Amyloid imaging in Alzheimer’s disease, frontotemporal dementia and healthy volunteersse of 18F-AV-45 positron emission tomography as early diagnostic technique in frontal lobe dementia and Alzheimer's disease.MedDRA version: 14.0 Level: PT Classification code 10061816 Term: Diagnostic procedure System Organ Class: 10022891 - InvestigationsEUCTR2008-003597-18-GBAvid Radiopharmaceuticals, Inc34