A Randomized Controlled Trial of Voriconazole in Allergic Bronchopulmonary Aspergillosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Relapse rates in the two groups
研究概览
简要总结
This is a research project to evaluate the efficacy and safety of two different treatment protocols in Allergic bronchopulmonary Aspergillosis.
详细描述
Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. The management of ABPA includes two important aspects - institution of immunosuppressive therapy in the form of glucocorticoids to control the immunologic activity, and close monitoring for detection of relapses. Another possible target is to use antifungal agents to attenuate the fungal burden secondary to the fungal colonization in the airways. Oral corticosteroids are currently the treatment of choice for ABPA associated with bronchial asthma.They not only suppress the immune hyperfunction but are also anti-inflammatory. However, there is no data to guide the dose and duration of glucocorticoids and different regimens of glucocorticoids have been used in literature.Itraconazole, an oral triazole with relatively low toxicity, is active against Aspergillus spp. in vitro and in vivo. The activity of itraconazole against Aspergillus spp. is more than that of ketoconazole. The administration of itraconazole can eliminate Aspergillus in the airways and can theoretically reduce the allergic responses in ABPA. The new triazoles, such as voriconazole, have recently been found effective in the treatment of fungal infections. The investigators hypothesize that voriconazole might also be useful in the treatment of ABPA. The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of voriconazole therapy in patients with ABPA.
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
- None
入排标准
- 年龄范围
- 15 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of all the following three criteria:
- •Immediate cutaneous hyperreactivity on aspergillus skin test
- •Elevated total IgE levels > 1000 IU/mL
- •A fumigatus specific IgE levels > 0.35 kUA/L
- •And, two of the following criteria:
- •Presence of serum precipitating antibodies against A fumigatus
- •Fixed or transient radiographic pulmonary opacities
- •Total eosinophil count > 1000/µL
- •Central bronchiectasis on HRCT
排除标准
- •Failure to give informed consent
- •Intake of glucocorticoids for more than three weeks in the preceding six months
- •Enrollment in another trial of ABPA
- •Any exposure to azoles in the last six months
研究组 & 干预措施
Steroid group
干预措施: Prednisolone (Drug)
Voriconazole group
干预措施: Voriconazole (Drug)
结局指标
主要结局
Relapse rates in the two groups
时间窗: 12, 18, 24 months
No ABPA exacerbations over the next 3 months after stopping therapy
Response rates in the two groups
时间窗: Six weeks and three months
IgE levels decline by \>=25 percent and there is clinical improvement with partial/total clearance of chest radiographic lesions \[if pulmonary opacities have been previously present\] after six and three months of treatment
次要结局
- Number of Participants with Adverse Events(4 months)
研究者
Ritesh Agarwal
Associate Professor
Post Graduate Institute of Medical Education and Research, Chandigarh
