EUCTR2017-003665-10-GB进行中（未招募）1 期
A single-centre study of the relationship between eosinophil activation and the lung microbiome in severe eosinophilic asthma (SEA) and the effect of benralizumab on these factors - Benralizumab and the lung microbiome (BALM)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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.Age 18-75 years
- •2.Weight =40kg
- •3.Severe asthma as defined in the 2014 ERS/ATS severe asthma guideline
- •4.Deemed eligible to commence benralizumab as NHS treatment according to NICE TA565
- •5.FEV1 = 60% predicted
- •6.ACQ-6 >1.5.
- •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 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1.Significant cardiac disease, e.g. ischaemic heart disease, cardiac failure, permanent pacemaker
- •2.Pregnant and breastfeeding
- •3.Significant respiratory disease, other than the condition being studied, e.g. chronic obstructive pulmonary disease, interstitial lung disease, obstructive sleep apnoea requiring treatment.
- •4.Current malignancy
- •5.Current smokers (All subjects must be non-smokers or ex-smokers for at least 12 months with <10 pack-years smoking history.)
- •6.Obesity (BMI>35kg/m2)
- •7.Rheumatoid arthritis
- •8.Confounding drugs (anti-asthma immune modulators other than steroids)
- •9.Treatment with a monoclonal antibody in the last 6 months
- •10.Known history of allergy or reaction to the study drug formulation, or history of anaphylaxis to any biologic therapy.
- •11.Long-term systemic antibiotics/ antifungals, or any course(s) of systemic antibiotics/ antifungals within the past 2 weeks.
- •12.Acute exacerbations of asthma (defined as a clinical episode requiring treatment with systemic corticosteroids, or requiring an increase in the dosage of systemic corticosteroids if the patient is on long term corticosteroid treatment) within the past 2 weeks
- •13.History of an upper or lower respiratory infection (including common cold) within the past 2 weeks
- •14.Female subjects who are pregnant/ breastfeeding/ less than 6 weeks post-partum at the time of enrolment, or who fulfil any of these criteria at any point prior to the final investigation (bronchoscopy)
- •15.Previous bronchial thermoplasty in the last 48 months.
- •16.Unable to provide written informed consent.
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