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临床试验/NCT01560689
NCT01560689已完成2 期

Open-labeled Trial to Evaluate the Therapeutic Effects of Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans After Allogeneic Stem Cell Transplantation

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
32
试验地点
1
主要终点
pulmonary function tests

研究概览

简要总结

The purpose of this study is to determine whether inhaled Budesonide/formoterol is effective in the treatment of bronchiolitis obliterans after allogeneic stem cell transplantation.

详细描述

Bronchiolitis obliterans (BO) is a life-threatening pulmonary late-onset complication following allogenic stem cell transplantation (SCT), commonly attributed to graft versus host disease (GVHD), and carries a poor prognosis. Although immunosuppressive treatments (IS) represents the main therapeutic approach in this disorder, these medications are rarely efficient and alternative approaches are strongly needed. Because, the combination of inhaled steroids and long-acting bronchodilator are known to decrease respiratory symptoms, prevent exacerbations and improve lung function in chronic obstructive pulmonary diseases with bronchiolar component, they may have beneficial effects in BO. Thus, the investigators conducted a pilot open-labeled trial to evaluate the therapeutic effects of inhaled Budesonide/Formoterol combination (400/12 µg twice a day) without modifying systemic IS received by the patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult allogeneic stem cell transplant recipients with clinical respiratory signs assumed to be secondary to BO, without extra-thoracic extensive graft versus host disease

排除标准

  • Extensive extra thoracic GVH necessitating increasing immunosuppressive treatments

研究组 & 干预措施

BUDESONIDE/FORMOTEROL

Active Comparator

干预措施: Budesonide/formoterol (Drug)

control

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

pulmonary function tests

时间窗: 1 month

Dyspnea based on NYHA classification

时间窗: 1 month

次要结局

  • pulmonary function test(7 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Bergeron

MD, PhD

Assistance Publique - Hôpitaux de Paris

研究点 (1)

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