Phase II clinical study of recombinant human granulocyte-macrophage colony stimulating factor (GMCSF) inhalation therapy for the treatment of patients with autoimmune (idiopathic) pulmonary alveolar proteinosis

iigata University Medical and Dental Hospital (Japan)0 个研究点目标入组 40 人开始时间: 2008年6月4日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Both males and females, age over 16 years and below 80 years (as of the date of registration)
•2. Patients from whom informed consent has been obtained in writing
•3. Patients who can be admitted to a hospital for a short period for evaluation at the start and the end of the treatment period
•4. Patients with autoimmune (idiopathic) pulmonary alveolar proteinosis who satisfy either criterion A or B below and whose serum anti-GM-CSF autoantibody level is in the positive range (over 0.5 microgram/ml):
•A: Typical pathological findings (pool of PAS-positive protein-like material in the alveoli) detected by transbronchial lung biopsy or surgical lung biopsy (thoracoscopic lung biopsy, etc.)
•B: Typical findings in bronchoalveolar lavage fluid (turbid, protein-like material; decreased macrophage count)
•5. Patients with resting PO2 below 75 mmHg at supine position

•1. White blood cell (WBC) of 12,000/microliter or more
•2. Fever of 38 degrees centigrade or more
•3. Grade 2 or severer oedema
•4. Malignant disease of the bone marrow
•5. Complication by congestive heart failure, angina pectoris, hemorrhagic tendency, primary lung carcinoma, metastatic lung carcinoma, bronchial asthma, etc., in which Leukine® therapy and its evaluation are considered as difficult
•6. Treatment with other cytokines
•7. Pregnant or possibly pregnant women, lactating women, and women who desire to become pregnant during the study period
•8. Patients who have undergone whole-lung lavage or repeated segmental-lung lavage 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)
•9. 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)

发起方

iigata University Medical and Dental Hospital (Japan)