JPRN-jRCT1091220205已完成2 期
Pulmonary alveolar proteinosis GM-CSF inhalation efficacy trial in Japan - PAGE
Koh Nakata0 个研究点目标入组 80 人开始时间: 2015年1月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
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
- >= 16age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1. age over 16 years and below 80 years (as of the date of registration).
- •2. can provide signed informed consent.
- •3. willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol (including short-term hospital admission).
- •4. Autoimmune pulmonary alveolar proteinosis diagnosed by both HR-CT and biopsy
- •and/or BAL as well as increased GM-CSF antibodies in serum more than 1mcg/ml.
- •5. PaO2 < 70 mmHg after 5 minutes spine position at room air, or PaO2 < 75 mmHg
- •after 5 minutes spine position at room air and with symptom(s) including cough,
- •sputum and exertional dyspnea
排除标准
- •1. Diagnosed as secondary or hereditary pulmonary alveolar proteinosis
- •2. WBC of 12,000/mm3 or more
- •3. Fever of 38 degree celsius or more
- •4. Severe edema
- •5. History of malignant disease within recent 5 years (not applied to the treated cases of uterine carcinoma in situ and local basal cell carcinoma)
- •6.Complication of cardiovascular diseases including congestive heart failure, angina pectoris, hemorrhagic tendency, etc with severe condition.
- •7.Complication of respiratory diseases such as pulmonary infectious disease (incl. pulmonary tuberculosis), bronchial asthma, lung fibrosis, interstitial pneumonitis, or bronchiectasis, in which the evaluations of safety and efficacy of GM-CSF therapy are considered as difficult.
- •8. History or complication of infectious diseases which require systemic administration of antibiotics, antifungal or antiviral agents within recent 2 weeks.
- •9. Treatment with other cytokines
- •10.Pregnant or possibly pregnant women, lactating women, and women who desire to become pregnant during the study period 11.Patients who have been treated with whole-lung lavage, repeated segmental-lung lavage, or rituximab within 6 months before the start of the study (this criterion does not apply to patients for whom 6 months or more have elapsed after their last lavage or rituximab)
- •12. Severe liver dysfunction (AST > 100 IU/L and/or ALT > 100 IU/L)
- •13. Severe renal dysfunction (Ccr < 30 mL/min, calculated by Cockcroft-Gault (CG) formula)
- •14. Previous experience of severe and unexplained side-effects during aerosol delivery of any kind of medicinal product
- •15. Treatment with oral or intravenous administration or inhalation of corticosteroids.
- •16. Treatment with other inhaled drugs.
- •17. Previously treated with GM-CSF before the start of the study.
- •18. Demonstrate hypersensitivity to GM-CSF agent.
- •19. Other patients judged to be inappropriate for the study by the attending physician (e.g., patients who are unlikely to complete treatment or are uncooperative).
研究者
相似试验
招募中
4 期
PAGEiiTrialAutoimmune pulmonary alveolar proteinosispulmonary alveolar proteinosis, GM-CSF, autoimmune disease, anti-GM-CSF autoantibodyC5670459JPRN-jRCTs031220127akata Koh60
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.
招募中
不适用
Pulmonary involvement (interstitial lung disease of known etiology) in patients with Seropositive and ACPA positive Rheumatoid Arthritis (RA-ILD I and II)Early detection of lung involvement in RAM05.9M05.1J99.0Seropositive rheumatoid arthritis, unspecifiedRheumatoid lung diseaseDRKS00028871Boehringer Ingelheim Pharma GmbH & Co. KG200