CTRI/2022/12/048206
Active, not recruiting
Phase 2
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)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: J459- Other and unspecified asthmaHealth Condition 2: B441- Other pulmonary aspergillosis
- Sponsor
- Cipla Ltd
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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