A Randomized Controlled Trial of Inhaled Amphotericin B for Maintaining Remission in Allergic Bronchopulmonary Aspergillosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Time to first relapse
研究概览
简要总结
Inhaled amphotericin, a antifungal drug would decrease Aspergillus colonization and decrease the occurrence of exacerbations of Allergic Bronchopulmonary Aspergillosis (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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ABPA in remission defined as follows:
- •Age 12-65 years
- •Diagnosis of ABPA in the Chest Clinic
- •Received glucocorticoids for management of ABPA according to the Chest clinic protocol (0.5 mg/kg/day for 4 weeks, 0.25 mg/kg/day for 4 weeks, 0.125 mg/kg/day for 4 weeks, subsequently taper and stop steroids over the next 4 weeks).
- •Clinicoradiologic improvement with decline in IgE levels. The chest radiograph and IgE levels after four months of steroid therapy would serve as the baseline
排除标准
- •Failure to provide informed consent
- •Involved in any other research protocol
研究组 & 干预措施
Inhaled budesonide
Nebulized budesonide 1 mg b.i.d. thrice a week for four months. Patients will also receive a metered dose inhaler of formoterol/budesonide (6/200) at a dose of 2 puffs b.i.d. and as and when required [max 10 puff/day]
干预措施: Inhaled budesonide (Drug)
Inhaled budesonide plus amphotericin
Amphotericin B deoxycholate (50 mg) will be dissolved in 10 mL sterile water for injection (5 mg/mL). The solution remains stable for at least 7 days at 2°C to 8°C. Ten milligrams of the drug (2 mL) will be nebulized over 10-15 minutes twice in a day for three times a week (Effective dose: 10 mg b.i.d. thrice a week) using a jet nebulizer. Nebulized budesonide will be administered at a dose of 1 mg b.i.d. thrice a week after nebulization with amphotericin B. The total duration of therapy would last 4 months. Patients will also receive a metered dose inhaler of formoterol/budesonide (6/200) at a dose of 2 puffs b.i.d. and as and when required [max 10 puff/day].
The first dose will be administered under direct supervision.
干预措施: Inhaled budesonide (Drug)
Inhaled budesonide plus amphotericin
Amphotericin B deoxycholate (50 mg) will be dissolved in 10 mL sterile water for injection (5 mg/mL). The solution remains stable for at least 7 days at 2°C to 8°C. Ten milligrams of the drug (2 mL) will be nebulized over 10-15 minutes twice in a day for three times a week (Effective dose: 10 mg b.i.d. thrice a week) using a jet nebulizer. Nebulized budesonide will be administered at a dose of 1 mg b.i.d. thrice a week after nebulization with amphotericin B. The total duration of therapy would last 4 months. Patients will also receive a metered dose inhaler of formoterol/budesonide (6/200) at a dose of 2 puffs b.i.d. and as and when required [max 10 puff/day].
The first dose will be administered under direct supervision.
干预措施: Inhaled amphotericin (Drug)
结局指标
主要结局
Time to first relapse
时间窗: 12 months
Relapse will be defined as clinical and/or radiological worsening along with 50% increase of the baseline IgE levels
次要结局
- ACQ-7 scores between the two groups(2, 4, 6, and 12 months)
- Improvement in forced expiratory volume in the first second (FEV1)(2, 4, 6, and 12 months)
- Adverse effects of therapy in both the arms(12 months)
- Number of asthma exacerbations requiring oral steroids(12 months)
研究者
Ritesh Agarwal
Associate Professor
Post Graduate Institute of Medical Education and Research, Chandigarh