JPRN-jRCTs031220127招募中4 期
Pulmonary Alveolar Proteinosis GM-CSF Inhalation Efficacy Trial II
akata Koh0 个研究点目标入组 60 人开始时间: 2022年6月10日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
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
- >= 12age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Persons aged older than 12 years at the time
- •of obtaining consent.
- •2) The name of the disease and the condition of th e disease have been fully explained
- •by the attendi ng physician in advance.
- •3) A person who has received sufficient explanatio n in participating in this research,
- •and who has obtained sufficient understanding and consent to the document at his / her own free will.
- •4) Baseline at 12 or 24 or 36 or 48 weeks afte r the start of administration
- •of the investigational drug
- •5) A case diagnosed with autoimmune alveolar proteinosis, that is, HRCT shows shadows matchin g this disease in both lungs, satisfying the following A or B, and serum anti-GM-CSF autoanti body concentration of 1.7 U / ml or more.
- •A: Typical pathological findings (intraalveolar rete ntion of PAS-positive protein-like substances) by tr ansbronchial lung biopsy or surgical lung biopsy (t horacic lung biopsy, etc.)
- •B: Typical findings in bronchoalveolar lavage fluid (white turbidity, increased protein-like substances, increased foamy macrophages)
- •6) A case with PaO2 under 70mmHg at spine position after breathlng roomair at least 5minute
排除标准
- •1) a. cases diagnosed with secondary alveolar prot
- •einosis or hereditary alveolar proteinosis.
- •2). cases with leukocyte count of 12000/mcl or mo re at the time of enrollment.
- •3). cases with fever or more at the time of enrollme nt
- •4) cases with marked edema of the extremities
- •5) Patients with a history of malignant tumor within the past 5 years (excluding patients with stable disease and during the follow-up period)
- •6) cases with severe symptoms due to cardiovascu lar diseases such as congestive heart failure and a ngina
- •7) cases with respiratory complications such as bronchial asthma, pulmonary infection (including pulmonary tuberculosis), pulmonary fibrosis, interstitial pneumonia, and bronchiectasis, and its efficacy and safety are expected to be difficult to evaluate.However, patients with non-tuberculous mycobacterial disease, pulmonary aspergillosis, or pulmonary nocardiosis who are being treated or have not been treated and have stable symptoms may be registered at the discretion of the attending physician.
- •8) cases with a history of infectious diseases or complications that require systemic administration of antibacterial agents, antifungal agents, antiviral agents, etc. for the past 2 weeks.However, systemic administration of antibiotics for nontuberculous mycobacterial disease, pulmonary aspergillosis, and pulmonary nocardiosis is not limited to this.
- •9) cases receiving other cytokine therapy.
- •10) pregnant and potentially pregnant women, lact ating women, or women who wish to become preg nant during the exam
- •11) cases treated with whole lung lavage, repeated segmental lavage, and rituximab within one month of enrollment.
- •12)Patients with severe liver dysfunction are defined as having at least one of AST (GOT) and ALT (GPT) of 100 U/l or more as a guideline, and the attending physician will make a judgment based on the symptoms and changes in laboratory values.
- •13) cases with severe renal dysfunction (cases wit h a Ccr of less than 30 according to the Cockcroft & Gault equation).
- •14)Patients who received oral or intravenous steroids within 2 months of enrollment.
- •However, oral administration to prevent rejection after transplantation is not limited to this criteria.
- •15) cases receiving GM-CSF inhalation therapy wit hin one months from the time of enrollment
- •16) cases with hypersensitivity to Leukine compon
- •17) other cases that the doctor in charge deems in
- •appropriate (cases that are considered difficult to
- •complete treatment, cases that interfere with inhal
- •er, vial operation, non-cooperative case etc.)
研究者
相似试验
已完成
2 期
Pulmonary alveolar proteinosis GM-CSF inhalation efficacy trial in Japaautoimmune pulmonary alveolar proteinosisJPRN-jRCT1091220205Koh Nakata80
已完成
2 期
Pulmonary Alveolar Proteinosis GM-CSF Inhalation Efficacy Trial in JapanPulmonary Alveolar Proteinosis, AutoimmuneNCT02835742Niigata University Medical & Dental Hospital78
终止
2 期
GM-CSF in Patients With Pulmonary Alveolar ProteinosisPulmonary Alveolar ProteinosisNCT00030056The Cleveland Clinic48
Available
不适用
Molgramostim Nebulizer Solution Expanded Access Program ProtocolAutoimmune Pulmonary Alveolar ProteinosisNCT06546098Savara Inc.
进行中（未招募）
1 期
asale Inhalation von Pulmozyme bei Patienten mit Mukoviszidose und chronischer Rhinosinusitis mit dem Pari Sinus-Vernebler.- bizentrische, randomisierte, doppel-blinde, placebo-kontrollierte, prospektive klinische Studie -Nasal Inhalation of Dornase alfa (Pulmozyme) in Patients with Cystic Fibrosis and Chronic Rhinosinusitis - pulmozyme-nasal-cfEUCTR2007-001548-36-DEniversity of Jena16