JPRN-jRCTs031180338已完成2 期
The prospective study to evaluate the efficacy of the combination therapy of inhaled budesonide/formoterol fumarate, clarithromycin, and montelukast in AFO after allogeneic SCT - Chiba AFO-01 study
Sakaida Emiko0 个研究点目标入组 85 人开始时间: 2019年3月18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
- 85
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 <= 70age old（—）
- 性别
- All
入选标准
- •1. The patient who receives the 1st allogeneic stem cell transplantation
- •2. The patient who can examine the pulmonary function tests.
- •3. PS (ECOG), 0-2
- •4. The patient who has no exceptionable organ problems
- •1) serum ALT/AST concentrations:150 IU/L and under
- •2) total bilirubin: 3mg/dL and under
- •3) CCr:40ml/min or over (by C-G)
- •4) arterial blood oxygen saturation or SpO2 in room air:94% or over
- •5. Written informed consent
排除标准
- •1. Known history of intolerance or allergy to any triplet component.
- •2. The patient who has past history of asthma and had attack within one year.
- •3. The patient who has already been treated with the triplet combination.
- •4. The patient who has active infection
- •5. The patient who has mental disability requiring treatment
- •6. The patient who has severe thromboembolism, including myocardial infarction, cerebral infarction, and cardiovascular complications.
- •7. The patient who has uncontrollable diabetes mellitus and metabolic disease
- •8. The patient who has other malignancy requiring anticancer treatment
- •9. Pregnancy or nursing.
- •10. At the time of enrollment as judged by the enrolling investigator would interfere
- •with the subjects ability to comply with the study requirements
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