JPRN-jRCTs071220023招募中2 期
Reducing effect of azithromycin for exacerbation in asthma patients who experiencing exacerbation: focusing on their body mass index - TARGET study
Tashiro Hiroki0 个研究点目标入组 50 人开始时间: 2022年6月29日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Asthma patients who have a history of the exacerbation in the past year, whose ages are from 20 and whose BMI are more than 25. Gender do not matter.
- •2) Patients who have been confirmed the diagnosis of asthma based on GINA guidelines: respiratory symptoms that are characteristic of asthma plus or minus wheeze, and clinical improvement (improvement of asthma symptoms and / or increase in FEV1 of >12% and >200 mL) by asthma treatment (ICS-LABA).
- •3) Patients provided written informed consent to participate in this study.
排除标准
- •1) Patients with serious hepatic dysfunction (serum AST or ALT >=100 IU/L), or renal dysfunction (BUN >=25 mg/dL or serum Cr >=2 mg/dL) at the time of registration.
- •2) Patients with paroxysmal tachycardia (more than 100 times / min) or life-threatening arrhythmia at the time of registration.
- •3) Patients with a history of myocardial infarction in the past year, or a history of hospitalization for heart failure in the past year.
- •4) Patients with a history of malignant tumor (except for basal cell carcinoma, squamous cell carcinoma, gastrointestinal malignant tumor, and only endoscopic mucosal resection) within the past 5 years (except for patients whose ECOG PS 0 is used and there is no problem with walking at the time of registration by the discretion of a specialist, and who is expected that there will be no recurrence of cancer requiring treatment during the period of participation in this study).
- •5) Patients who treated by macrolide antibiotics within 4 weeks before intervention day.
- •6) Patients who treated by biological agents within 8 weeks before intervention day.
- •7) Patients whose QTc are more than 480ms on electrocardiogram at the time of registration.
- •8) Patients who are pregnant or under lactating.
- •9) Patients whose BMI are less than 25.
- •10) Other patients who are judged to be inappropriate by the principal investigator or the investigator.
研究者
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