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临床试验/NCT01621321
NCT01621321已完成2 期

A Randomized Controlled Trial of Voriconazole in Allergic Bronchopulmonary Aspergillosis

Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013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
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

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

Experimental

干预措施: Prednisolone (Drug)

Voriconazole group

Experimental

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

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ritesh Agarwal

Associate Professor

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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