Voriconazole For Primary Therapy Of Proven, Chronic Bronchopulmonary Aspergillosis, In Minimally Immunocompromised Or, Non-Immunocompromised Hosts
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of Subjects With Successful Global Outcome at 6 Months: Chronic Bronchopulmonary Aspergillosis
研究概览
简要总结
To evaluate the efficacy of voriconazole (VFend(R)) as first line treatment for proven chronic bronchopulmonary aspergillosis, in minimally immunocompromised or non-immunocompromised patients after 6 months of treatment i.e. chronic necrotizing pulmonary
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
- •Patients with a chronic bronchopulmonary aspergillosis assessed by a compatible chest imagery (CT scan) and/or an endoscopic lesion sourced by photo, would it be:
- •Complex aspergilloma non primarily operable,
- •Chronic necrotizing pulmonary aspergillosis,
- •Tracheo-bronchial aspergillosis, obstructive or necrotizing/pseudo-membranous.
排除标准
- •Patient with risk factor(s) of cardiac arrhythmia, symptomatic arrhythmia, treated by medication known to prolong QT interval, or prolongation of QTc interval > 450 msec in men and > 470 msec in women.
- •Simple aspergilloma with primary indication of surgical treatment.
研究组 & 干预措施
1
干预措施: Voriconazole (Drug)
结局指标
主要结局
Number of Subjects With Successful Global Outcome at 6 Months: Chronic Bronchopulmonary Aspergillosis
时间窗: at 6 months of treatment
Successful global outcome: composite assessment of radiological and mycological responses; defined as complete or partial radiological response and mycological eradication (absence of aspergillus); no success=criteria not met. Assessment was determined by the Data Review Committee (DRC). Complete response: resolution of radiographic and or bronchoscopic abnormalities attributable to aspergillosis present at baseline; partial response: reduction in diameter ≥ 50 percent on chest tomodensitometry (TDM) or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.
次要结局
- Number of Subjects With Successful Global Outcome at Month 3 and End of Treatment: Chronic Bronchopulmonary Aspergillosis(Month 3 and End of Treatment (Month 9 or Month 12))
- Number of Subjects With Successful Global Outcome at 6 Months: Chronic Necrotizing Pulmonary Aspergillosis (CNPA) and Tracheo-bronchial Aspergillosis(at 6 months of treatment)
- Number of Subjects With Successful Global Outcome at 6 Months: Complex Aspergilloma(at 6 months of treatment)
- Change From Baseline in Respiratory Clinical Signs and Symptoms on Visual Analog Scales (VAS)(Baseline, Month 3, and Month 6, Month 9, or Month 12 [EOT], and End of study ([EOS] EOT + 6 months))
- Number of Subjects With Relapse(During the 6 months following EOT (EOT + 3 months, EOT + 6 months))
- Time to Relapse After EOT(During the 6 months following EOT (EOT + 3 months, EOT + 6 months))
- Global Survival: Number of Subjects With an Outcome of Death(Baseline through EOS (EOT + 6 months))
- Change From Baseline in Quality of Life (QOL): St. George's Hospital Respiratory Questionnaire(Baseline, Month 3, and Month 6, Month 9, or Month 12 [EOT], and EOS (EOT + 6 months))
- Number of Subjects With Complete or Partial Radiological Response(Month 3, and Month 6, Month 9, or Month 12 [EOT])
- Number of Subjects With Mycological Response of Eradication(Month 3, and Month 6, Month 9, or Month 12 [EOT])
- Number of Subjects With Complete or Partial Serological Response(Month 3, and Month 6, Month 9, or Month 12 [EOT])