Pilot Study of Cyclosporine A Dry Powder Inhalation in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in Forced Expiratory Volume in 1 second before and after intervention
研究概览
简要总结
The purpose of this study is to investigate whether dry powder inhalation of Cyclosporine A is beneficial in lung transplant patients with Bronchiolitis Obliterans Syndrome. For patients suffering from this syndrome often no therapeutic options are available. Furthermore, the side effects of the maintenance therapy leaves no room for dose increments. The hypothesis for this trial is that when Cyclosporine A is administered locally (in the lungs) chronic rejection can be treated more effectively without extra systemic side effects.
详细描述
Because calcineurin inhibitors are not completely effective in a full prevention of acute rejection and the corresponding chronic disfunction of the transplanted organ (Bronchiolitis Obliterans Syndrome, BOS) a rejection risc remains. To effectively treat BOS high doses of calcineurin inhibitors are necessary. On the other hand these high doses lead te serious side effects. The search for a balance between effectiveness and side effects leads to dose adjustments. Ultimately, chronic rejection is unstoppable.
In order to treat chronic rejection higher doses of calcineurin inhibitors are not a therapeutic option. The only option to reach a high dose in the target organ without extra systemic side effects would be inhalation. Indeed, this has been extensively investigated at the University of Pittsburgh (lead investigator Iacono).
The intervention in the Pittsburgh trials existed of nebulization of Cyclosporine in propylene glycol with pretreatment of nebulization of lidocaine/albuterol in order to make the inhalation tolerable.
The investigational drug in this trial consists of dry powder inhalation of a sugar-glass based solid dispersion containing cyclosporine A. The effectiveness is measured by comparing the Forced Expiratory Volume in 1 second (FEV1) before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Signed Informed Consent
- •Primary lung transplant
- •Tacrolimus as maintenance therapy
- •Bronchiolitis Obliterans Syndrome stages 1 - 3: FEV1<80% of baseline
- •At least 3 months after last usual BOS intervention
- •Declining FEV1 after last usual BOS intervention
排除标准
- •Cyclosporine as maintenance therapy
- •Bronchiolitis Obliterans Syndrome 0: FEV1>80%
- •Renal failure: Glomerular Filtration Rate < 30 ml/min
- •Chronic airway infections
- •Clinical stability
- •Pregnancy
结局指标
主要结局
Change in Forced Expiratory Volume in 1 second before and after intervention
Amount of lung deposition of cyclosporine A
Systemic uptake of Cyclosporine A
次要结局
- Kidney function (GFR and serum creat)