A Randomized Trial of Itraconazole in Acute Stages of Allergic Bronchopulmonary Aspergillosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Glucocorticoid-dependent ABPA
研究概览
简要总结
The study evaluates the addition of itraconazole to glucocorticoids in management of acute stages of allergic bronchopulmonary aspergillosis (ABPA). Half of the participants will receive glucocorticoids while the other half will receive itraconazole and glucocorticoids
详细描述
The management of allergic bronchopulmonary aspergillosis (ABPA) includes two important aspects namely 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.
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. We hypothesize that itraconazole when given in the acute stages of ABPA will decrease the chances of relapse and progression to glucocorticoid-dependent 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
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment naive patients of allergic bronchopulmonary aspergillosis (ABPA) defined by the presence of all the following:
- •immediate cutaneous hyperreactivity on Aspergillus skin test or A.fumigatus specific IgE levels >0.35 kUA/L
- •elevated total IgE levels >1000 IU/mL and, two of the following features:
- •presence of precipitating antibodies against A.fumigatus in serum
- •fixed or transient radiographic pulmonary opacities
- •total eosinophil count >1000/µL
- •bronchiectasis on HRCT chest
排除标准
- •Intake of systemic glucocorticoids for more than three weeks in the preceding six months
- •Exposure to azoles in the last six months
- •Immunosuppressive states such as uncontrolled diabetes mellitus, chronic renal failure, chronic liver failure and others
- •Patient on immunosuppressive drugs
- •Pregnancy
- •Enrollment in another trial of ABPA
- •Failure to provide informed consent
研究组 & 干预措施
Glucocorticoid group
Oral prednisolone 0.5 mg/kg/day for 4 weeks; 0.25 mg/kg/day for 4 weeks; 0.125 mg/kg/day for 4 weeks. Then taper by 5 mg every 4 weeks and discontinue by the end of 4 months. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) 1 puff BD and as needed as per the SMART approach for control of asthma
干预措施: Glucocorticoids (Drug)
Itraconazole plus glucocorticoid group
Oral itraconazole 200 mg BD for 6 months AND oral prednisolone 0.5 mg/kg/day for 4 weeks; 0.25 mg/kg/day for 4 weeks; 0.125 mg/kg/day for 4 weeks. Then taper by 5 mg every 4 weeks and discontinue by the end of 4 months. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) 1 puff BD and as needed as per the SMART approach for control of asthma.
干预措施: Itraconazole (Drug)
Itraconazole plus glucocorticoid group
Oral itraconazole 200 mg BD for 6 months AND oral prednisolone 0.5 mg/kg/day for 4 weeks; 0.25 mg/kg/day for 4 weeks; 0.125 mg/kg/day for 4 weeks. Then taper by 5 mg every 4 weeks and discontinue by the end of 4 months. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) 1 puff BD and as needed as per the SMART approach for control of asthma.
干预措施: Glucocorticoids (Drug)
结局指标
主要结局
Glucocorticoid-dependent ABPA
时间窗: 24 months
If the patient has relapse on two or more consecutive occasions within 6 months of stopping treatment or requires oral steroids for control of asthma
Relapse rates
时间窗: 12 months
Doubling of the baseline IgE levels irrespective of the patient's symptoms or appearance of radiologic infiltrates; or clinical and/or radiological worsening with 50% increase in IgE over the previous baseline value
次要结局
- Treatment-related adverse effects(Six months)
- Percentage decline in IgE(Six weeks)
- Proportion of patients with a response rates(Six weeks)
- Time to first relapse(Two years)
研究者
Ritesh Agarwal
Professor, Department of Pulmonary Medicine, Principal Investigator
Post Graduate Institute of Medical Education and Research, Chandigarh