A randomized, phase 2 dose finding study of itraconazole as dry powder for inhalation in adult patients with Acute bronchopulmonary Aspergillosis (ABPA)
- Conditions
- Health Condition 1: J459- Other and unspecified asthmaHealth Condition 2: B441- Other pulmonary aspergillosis
- Registration Number
- CTRI/2022/12/048206
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Effect of daily administration of PUR1900 in adult subjects with asthma and ABPA on measures of efficacy (at week 4, 8, 12 and 16 from baseline) including lung function, asthma control and quality of life: <br/ ><br>2 To determine the dose of PUR1900 <br/ ><br>3 To evaluate the safety and tolerability of PUR1900 administered in adult subjects with asthma and ABPA.Timepoint: 1. Week 4, 8, 12 and 16 from baseline <br/ ><br>2 Week 16 from baseline. <br/ ><br>3. Across all visits from baseline visit.
- Secondary Outcome Measures
Name Time Method o secondary endpoint.Timepoint: No secondary endpoint.