Randomized Controlled Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Glucocorticoid-dependent ABPA
研究概览
简要总结
Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. 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. The disorder is highly prevalent in India. The investigators have previously reported their experience with screening stable outpatients with bronchial asthma and acute severe asthma for ABPA. The investigators have also recently reported the prognostic factors associated with clinical outcomes in patients with ABPA.
The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of two different glucocorticoid dose protocols in patients with ABPA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ABPA
- •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 kU/L, AND,
- •Presence of two of the following criteria:
- •presence of serum precipitating antibodies against A fumigatus
- •fixed or transient radiographic pulmonary opacities
- •absolute eosinophil count > 1000/µL
- •central bronchiectasis on HRCT
排除标准
- •If they have taken glucocorticoids for more than three weeks in the preceding six months
- •Failure to give informed consent
- •Enrollment in another trial of ABPA
研究组 & 干预措施
Low-dose glucocorticoid
Low-dose steroid
干预措施: Glucocorticoids (Drug)
High-dose glucocorticoid
High-dose steroid
干预措施: Glucocorticoids (Drug)
结局指标
主要结局
Glucocorticoid-dependent ABPA
时间窗: two year
relapse rates in the two groups
时间窗: one year
次要结局
- time to first relapse(one year)
- glucocorticoid related adverse effects in the two groups(two years)
- response rates in the two groups(six weeks)
研究者
Ritesh Agarwal
Additional Professor
Post Graduate Institute of Medical Education and Research, Chandigarh