CTRI/2022/12/048206进行中（未招募）2 期
A Randomized, Double Blind, Placebo-Controlled, Prospective, Multicentre, Phase 2, Dose-Finding Study of Itraconazole Administered as a Dry Powder For Inhalation (PUR1900) In Adult Subjects With Asthma And Allergic Bronchopulmonary Aspergillosis (ABPA)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Cipla Ltd
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Subjects with confirmed asthma and allergic bronchopulmonary aspergillosis (ABPA).
- •2. ABPA patients who at screening are symptomatic and have IgE = 1000 IU/ml and ACQ 7 score > 1.5 and/or have been on systemic glucocorticoids < 10 mg/day of prednisolone for at least the past one month.
- •3. Subjects able to perform valid reproducible spirometry with demonstration of pre-bronchodilator FEV1 = 50% to < 85% of predicted normal for age, sex, race, and height at a screening visit.
排除标准
- •1.Subjects who have used systemic azole antifungal agent in the past 3 months before first dose of study drug.
- •2.Subjects with a 12-lead ECG demonstrating a mean QT interval corrected by the Fridericia formula (QTcF) >450 ms for a male subject or >470 ms for a female subject at screening (A repeat triplicate ECG is allowed if a mean QTcF >450 msec is recorded at Visit 1).
- •3.Subjects on any anti-IgE (omalizumab) or anti-interleukin-5 biologics or any other monoclonal antibodies for asthma in the 6 months before the first dose of study drug.
研究者
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