A randomized, phase 2 dose finding study of itraconazole as dry powder for inhalation in adult patients with Acute bronchopulmonary Aspergillosis (ABPA)

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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/048206

Enrollment

Registered

2022-12-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J459- Other and unspecified asthma Health Condition 2: B441- Other pulmonary aspergillosis

Interventions

Intervention1: PUR1900: 20 mg dry powder for Inhalation administered once daily Intervention2: PUR1900: 20 mg, 40 mg dry powder for Inhalation administered once daily for 16 weeks Control Intervention

Eligibility

Inclusion 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 3. Subjects able to perform valid reproducible spirometry with demonstration of pre-bronchodilator FEV1 = 50% to

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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: 2 To determine the dose of PUR1900 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 2 Week 16 from baseline. 3. Across all visits from baseline visit.	—

Measure

Time frame

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: 2 To determine the dose of PUR1900 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 2 Week 16 from baseline. 3. Across all visits from baseline visit.

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Secondary

Measure	Time frame
No secondary endpoint.Timepoint: No secondary endpoint.	—

Countries

India

Contacts

Public ContactMr Abhijit Vaidya

Cipla Limited

sandesh.sawant3@cipla.com022-23025006

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026