NCT03960606

Study in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, & Pharmacokinetics of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Asthmatic Patients With ABPA

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Pulmatrix Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis

Detailed description

This is a randomized, double-blind, multicenter, placebo controlled, multiple-arm study. Following screening and confirmation of eligibility, subjects will be randomly assigned (1:1:1:1) into 4 arms of 16 subjects each and will receive 10 mg, 20 mg, or 35 mg of PUR1900 or placebo, administered via dry powder inhalation daily for 28 days. The doses of PUR1900 are stated in this protocol as the respective nominal doses of itraconazole. Subject eligibility for the study will be determined within 28 days before the first dose of study drug (Day 1) and will be confirmed between 9 and 6 days before dosing and again on Day 1. Eligible subjects will begin daily dosing with study drug (PUR1900 or placebo) on Day 1. Subjects will return to the study site for visits on Days 2, 7, 14, and 28 and will be dosed at the study site. The remaining daily doses of study drug will be self-administered at home. A follow-up visit will occur 7 to 10 days after the last dose of study drug.

Conditions

• Allergic Bronchopulmonary Aspergillosis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	PUR1900	PUR1900 contains itraconazole as the active ingredient, and it is formulated as a dry powder for oral inhalation.
COMBINATION_PRODUCT	Placebo	PUR1900 placebo

Timeline

• Start date: 2019-07-31
• Primary completion: 2020-07-14
• Completion: 2020-07-14
• First posted: 2019-05-23
• Last updated: 2021-08-27

Locations

20 sites across 5 countries: United States, Australia, India, Poland, United Kingdom

Regulatory

• FDA-regulated drug study