NCT05667662

Study to Evaluate Itraconazole Administered as Inhaled Dry Powder in Adults With Asthma and ABPA

Study to Evaluate the Effect of Dose and Duration of Treatment of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) on Safety, Tolerability, and Potential Outcomes in Adult Patients With ABPA

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Pulmatrix Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about PUR1900 as an inhaled, antifungal therapeutic for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma. The main questions it aims to answer are: 1. Is PUR1900 safe and well tolerated in adults with asthma and ABPA? 2. Is there an effect of daily administration of PUR1900 on potential outcome measures in adults with asthma and ABPA? 3. Is there fungal resistance to A. fumigatus? This study includes a 28-day screening period, a 112-day (16-week) treatment period, and a 56-day (8 week) observation period. Participants will take either 40mg of PUR1900, 20 mg of PUR1900 or Placebo for 112 days and complete an eDairy, answer questions about their asthma and complete peak respiratory flow measurements at home. They will come to the clinic approximate once a month during the treatment period and complete study assessments. At the end of the observation period participants will complete one more clinic visit. Participants who complete this study may be given the opportunity to continue on study drug in an open label extension study.

Conditions

• ABPA

Interventions

Type	Name	Description
DRUG	Itraconazole Powder	Capsules with 20 mg total powder (10 mg itraconazole plus 10 mg excipients)
DRUG	Placebo	Capsules with 11.8 mg total powder (excipients only)

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-02-27
• Completion: 2024-02-27
• First posted: 2022-12-28
• Last updated: 2024-04-02

Locations

18 sites across 4 countries: United States, Australia, France, United Kingdom

Regulatory

• FDA-regulated drug study