JPRN-jRCTs031190237进行中（未招募）4 期
A study on the effect of benralizumab in patient with severe asthma - A study on the effect of benralizumab in patient with severe asthma
Fukunaga Koichi0 个研究点目标入组 100 人开始时间: 2020年3月3日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Asthma patients over 20 years old
- •2) Weight over 40kg
- •3) Compliance with inhaled steroid (ICS) is over 80% and fluticasone (FP) equivalent ICS has been taken over 1000 micro g/day since 3 months before.
- •4) In addition to take ICS since 3 months before, at least one long-term administration drug (long -acting beta2 inhalation stimulant (LABA), leukotriene receptor antagonist, inhaled anticholinergic or theophylline) taking.
- •5) Blood eosinophil count before treatment with benralizumab is over 150 / micro L
- •6) In addition to the above criteria, the patient must meet at least one of the following criteria.
- •(1) At least one asthma exacerbation has been diagnosed within two years.
- •The definition of exacerbation is as follows
- •(Deterioration requiring treatment with systemic steroids for at least 3 days (when be taken systemic steroids as a long-term medicine, it is defined as temporary increase from maintenance dose), or aggravation requiring emergency outpatient consultation or emergency hospitalization due to asthma)
- •(2) ACQ-5 score is under1.5 (control failure)
- •(3) Pre-bronchodilator FEV1 is <80% of predicted value
排除标准
- •1) Patient who cannot obtain written consent by his/her own free will.
- •2) Patient complicated with bronchiectasis, diffuse pan bronchiolitis, collagen disease, pulmonary hypertension, sequelae of tuberculosis, interstitial pneumonia, allergic bronchopulmonary aspergilli / mycosis
- •3) Patient diagnosed with COPD
- •4) Patient who is smoking or have a history of smoking within 6 months
- •5) Malignant tumors: patient is in disease or within a year after remission
- •6) Patient was diagnosed with eosinophilia syndrome, eosinophilic polyangiitis granulomatous disease
- •7) Patient was diagnosed with parasitic helminth infection within 6 months
- •8) Patient have already received clinical trials or treatments of benralizumab
- •9) Patient received bronchial hyperthermia within a year
- •10) Have a history of anaphylaxis for biological products
- •11) Patient is being treated with other biologics and the last medication is less than a month
- •12) Pregnant or nursing woman
- •13) The condition is not stable because of cardiovascular or gastrointestinal tract, liver, kidney, nerve, musculoskeletal, infection, endocrine, metabolism, blood, mental disorder etc. and serious physical disorder. In addition, a principal investigator or sub-investigators judged that the following items may apply
- •(1)Affects the safety of the patient while the study period.
- •(2)Influence the study results and their interpretation
- •(3)The study will not able to be completed with the condition or situation of the patient
- •14) Patient diagnosed with acute upper or lower respiratory tract infection requiring administration of antibiotics or antivirals
- •15) Patient with a history of hypersensitivity for benralizumab and its components.
- •16) In addition, the attending physician judged the patient as inappropriate
研究者
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