A Randomized Placebo Controlled Trial of Inhaled Beclomethasone After Community-acquired Respiratory Viral Infection in Lung Transplant Recipients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Participants Free From New or Progressive Chronic Lung Allograft Dysfunction
研究概览
简要总结
The purpose of this study is to determine if the use of inhaled beclomethasone after a community-acquired respiratory viral infection in a lung transplant recipient decreases the risk of the subsequent development of chronic lung allograft dysfunction.
详细描述
Community-acquired respiratory viral (CARV) infections after lung transplantation are associated with an increased risk for the development of chronic lung allograft dysfunction (CLAD) after lung transplantation. The exact mechanisms whereby CARV infections increase this risk are unknown. We propose that viral infection results in airway epithelial cell injury and the expression of injury-response genes that provide signals that initiate immunologic and non-immunologic pathways that result in the airway remodeling characteristic of obliterative bronchiolitis, the predominant pathology of CLAD. Systemic and inhaled corticosteroids are frequently used as anti-inflammatory agents to treat the peribronchiolar inflammation seen in viral bronchiolitis. Beneficial effects from corticosteroids have been reported, but this has not been demonstrated in lung transplant recipients. The aim of this single center, randomized, double blind, placebo controlled study is to evaluate the short and long term effects of a 6 month course of inhaled beclomethasone on adult lung transplant recipients with CARV infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥ 18 years old)
- •Single, bilateral, or heart-lung transplant recipient
- •Confirmed infection with a community-acquired respiratory virus including: adenovirus, coronavirus, influenza A or B, respiratory syncytial virus (RSV), parainfluenza virus (PiV), human metapneumovirus (hMPV), and rhinovirus
- •At least 6 months post-transplant, with completion of 6 month bronchoscopy if indicated
- •Able and willing to give written informed consent and comply with study procedures (e.g. testing, treatment)
排除标准
- •BOS Stage 3
- •Requirement for mechanical ventilation at study entry
- •Use of inhaled steroids at the time of CARV infection
- •Any condition that in the investigator's opinion would preclude the patient's participation in a clinical trial
- •Lack of available spirometric data to establish a baseline forced expiratory volume in 1 second and/or forced vital capacity
- •Pregnancy
- •Current participation in another interventional clinical trial
研究组 & 干预措施
Placebo
Inhaled placebo twice daily for 180 days.
干预措施: Placebo (Drug)
Inhaled beclomethasone
Inhaled beclomethasone 320 mcg twice daily for 180 days.
干预措施: Inhaled beclomethasone (Drug)
结局指标
主要结局
Number of Participants Free From New or Progressive Chronic Lung Allograft Dysfunction
时间窗: 180 days
Death
时间窗: 180 days
次要结局
- Donor-specific Antibodies(180 days)
- Lymphocytic Bronchiolitis(180 days)
- Acute Rejection(180 days)
- Chronic Lung Allograft Dysfunction(180 days)