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临床试验/JPRN-jRCT1091220205
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

发起方
Koh Nakata

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