NCT00070590已完成2 期
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis
Actelion0 个研究点目标入组 132 人开始时间: 2003年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 主要终点
- Change from baseline to End-of-Study in 6-minute walk distance.
研究概览
简要总结
Clinical and experimental studies suggest that bosentan could delay the progression of interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for which no established efficacious treatment is available. The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO Class III and IV, to a new category of patients suffering from ILD associated with SSc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Main inclusion criteria:
- •Systemic Sclerosis diffuse or limited
- •Significant Interstitial Lung Disease on HRCTscan
- •DLco < 80% predicted
- •Dyspnea on exertion
- •Walk not limited by musculoskeletal reasons
排除标准
- •Interstitial Lung Disease due to other conditions than SSc
- •End stage restrictive or obstructive lung disease
- •Severe cardiac or renal diseases
- •Significant pulmonary arterial hypertension
- •Smoker (> 5cig./day)
- •Treatment with immunosuppressive, antifibrotic drugs, high dose corticosteroids (within 4 weeks of randomization)
结局指标
主要结局
Change from baseline to End-of-Study in 6-minute walk distance.
次要结局
- Time to death (all causes) or to worsening of PFTs up to End-of-Study.
- Worsening of PFTs (on 2 consecutive tests at least 4 weeks apart) is defined as: decrease from baseline ≥ 10% in FVC OR decrease from baseline ≥ 15% in DLco AND ≥ 6% in FVC
研究者
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