NCT01327625终止不适用
A Pilot Study Evaluating the Efficacy of Azithromycin, N-acetylcystein and Inhaled Corticosteroid Combination Therapy for Bronchiolitis Obliterans After Allogeneic Hematopoietic Cell Transpantation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Response rate based on the improvement of FEV1
研究概览
简要总结
[Study Objectives]
- To evaluate the efficacy of azithromycin, N-acetylcystein, and inhaled corticosteroid combination therapy in patients with bronchiolitis obliterans as a complication of allogeneic hematopoietic cell transplantation in terms of response rate at 6 months after treatment initiation based on the improvement of FEV1.
详细描述
- Bronchiolitis obliterans (BO) is a graft-versus-host disease of respiratory organs.
- Prognosis of BO is very poor, and the overall outcome of patients who are involved in BO is very dismal.
- The mechanism of BO has been known to be associated with immune / non-immune response.
- Corticosteroid and immunosuppressants are recommended as a best current treatment options for BO, which have been not satisfactory.
- Many treatment options have been tried to improve the outcome of BO.
- Azithromycin, as an immune modulating agent, has been tried for the treatment of BO, and has been reported to show hopeful results.
- N-acetylcystein, as an antioxidative agent, has been tried for BO.
- Inhaled corticosteroid may help to improve airway inflammation and decrease the amount of systemic corticosteroid.
- These 3 drugs are widely used for other respiratory disease, have been proven to be safe, and have shown some efficacy for BO in various depth of evidence.
- In these rationale, we'd like to try the 3-drug combination for BO, to assess the efficacy and safety of these drug combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who previously received allogeneic hematopoietic cell transplantation due to hematologic malignancy, bone marrow failure syndrome, and other compatible disease.
- •Patients who are diagnosed as bronchiolitis obliterans (BO) according to the NIH diagnostic guideline which is suggested as below.
- •Patients should be 15 years of age or older, but younger than 75 years.
- •Patients should have estimated life expectancy of more than 3 months.
- •Patients must have adequate hepatic function (bilirubin less than 3.0 ㎎/㎗, AST and ALT less than three times the upper normal limit).
- •Patients must have adequate renal function (creatinine less than 2.0 ㎎/㎗).
排除标准
- •Presence of significant active infection
- •Presence of uncontrolled bleeding
- •Any coexisting major illness or organ failure
- •Patients with a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
- •Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
- •Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
研究组 & 干预措施
Azithromycin
Experimental
Patient who are diagnosed as bronchiolitis obliterans according to the WHO criteria
干预措施: azithromycin + N-acetylcystein + inhaled corticosteroid (Drug)
结局指标
主要结局
Response rate based on the improvement of FEV1
时间窗: 6 months
Response rate at 6 months after treatment initiation based on the improvement of FEV1
次要结局
- Clinical benefit rate based on the degree of change in FEV1(6 months)
- change in FEV1 compared with pretreatment level(6 months after treatment initiation)
- Reduction rate in immunosuppressive agent / systemic corticosteroid(6 months after treatment initiation)
- Discontinuation rate in immunosuppressive agent / systemic corticosteroid(6 months after treatment initiation)
- Change in dose-intensity of immunosuppressive agent / systemic corticosteroid compared with pretreatment dose-intensity(6 months after treatment initiation)
- event-free survival(1 year)
- overall survival(1year)
研究者
Dae-Young Kim
Assistant Professor
Asan Medical Center
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Efficacy and Safety of Azithromycin and Artesunate in Pregnant WomenMalariaNCT00287300University of North Carolina141
已完成
3 期
Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot)Uncomplicated Severe Acute MalnutritionNCT03568643University of California, San Francisco301
已完成
3 期
The Effect of Azithromycin in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Productive CoughCoughChronic Obstructive Pulmonary DiseaseChronic BronchitisNCT01071161Isala84
已完成
2 期
Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) BronchiolitisRSV BronchiolitisNCT01486758Washington University School of Medicine40
终止
2 期
Azithromycin as a Quorum-Sensing Inhibitor for the Prevention of Pseudomonas Aeruginosa Ventilator-Associated PneumoniaPneumonia, Ventilator-AssociatedPseudomonas InfectionsNCT00610623Anbics Management-Services Ag92