EUCTR2020-000421-76-FI进行中（未招募）1 期
Aggravated airway inflammation: research on biological treatment (Mepolizumab) AirGOs-biologics
Helsinki University Hospital0 个研究点目标入组 120 人开始时间: 2020年3月26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
- 120
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
- •-=18 years of age
- •-chronic rhinosinusitis with bilateral polyps. Endoscopic bilateral nasal polyp score of at least 5 (out of 8), with a minimum score of 2 in each nasal cavity
- •-SNOT-22 =25
- •-At least one other symptom, such as partial loss of smell (hyposmia), nasal obstruction, total loss of smell (anosmia), or anterior or posterior rhinorrhea
- •-=1 previous CRS-surgery. Note that the last CRS-surgery must have been performed at least 6 months before 1st visit
- •-Peripheral blood eosinophils (PBEos) >300 cells/ul at visit 1 OR (PBEos >150 cells/ul at visit 1 AND a history of PBEos >300 cells/ul during the past 12 months). A history of Nasal polyp tissue eosinophilia (NPeos) =30% during the past 12 months is a supportive criterion.
- •-patient should have a history of at least one exacerbation during the past two years e.g. at least one criterion must be fulfilled of the following list during the past two years =1 oral corticosteroids; =3 antibiotic courses; =1 CRS-operation; = 1 asthma hospitalization. In patients with contraindications of previously listed treatment or continuous oral steroids, additional criteria are not required.
- •-Asthma diagnosis (patient has the National Social Insurance Institution´s reimbursement right for asthma medication)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •-Age <18 years
- •-CRS-surgery < 6 months before 1st visit
- •-pregnancy/ breastfeeding
- •-complication of CRS (f.ex. mucocele, invasive fungal rhinosinusitis). Take sinus CT scans, if needed!
- •-acute rhinosinusitis/respiratory infection
- •-severe disease related to airways/ immunology: cystic fibrosis, primary ciliary dyskinesia (PCD), sarcoidosis, immunosuppression, diagnosed Specific antibody deficiency (SAD), CVI, HIV, fungal rhinosinusitis; Young syndrome; Kartagener syndrome;
- •-other severe disease such as active cancer
- •-Received biologic therapy/systemic immunosuppressant/ASA desensitization therapy/experimental monoclonal antibody treatment to treat inflammatory or autoimmune disease within 2 months of study entry or 5 half-lives, whichever is longer. The patient is allowed to use ASA dose <100 mg/day due to cardiovascular reasons after ASA desensitization.
- •-current immunotherapy
- •-communication problems (f.e. neurological/psychiatric disease, language skills)
- •-unlikely to comply
- •-ASA-challenge negative.
- •-History of hypersensitivity to mepolizumab or excipients in the formulation
研究者
相似试验
进行中（未招募）
1 期
Aggravated airway inflammation: research on genomics and optimal treatments (AirGOs)Acetylsalicylic acid (ASA-) exacerbated respiratory disease (AERD).EUCTR2017-001570-42-FIHelsinki University Hospital150
尚未招募
不适用
Aggravated airway inflammation: research on genomics and optimal surgical treatmentchronic rhinosinusitis with nasal polypsnasal polyps10038737NL-OMON50207Academisch Medisch Centrum80
未知
不适用
Analysis of Airway Inflammatory state alteration after intravenous L-Arginine loadingChildren who are required growth hormone (GH) stimulation tests to diagnose GH deficiency. These are children whose heights are two standard deviations (SD) below the mean for age and sex, and/or whose growth velocities are 1.5 SD below the mean for age and sex over 2 years'follow-up, or whose pediatric endocrinologists order growth hormone (GH) stimulation test for another reasons.JPRN-UMIN000027260Osaka City University Graduate School of Medicine15
已完成
不适用
Mechanisms of airway inflammation in severe/refractory asthmaBronchial asthmaJPRN-UMIN000008401Wakayama Medical University Third Department of Internal Medicine20
已完成
不适用
Inflammatory Processes in the Airway of Asthmatics With Persistent Bronchial HyperreactivityAsthmaNCT00217854Washington University School of Medicine27