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

NCT05667662 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-04-02

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Pulmatrix Inc.

    lead INDUSTRY

Principal Investigators

  • Chris Cabell, MD · Pulmatrix Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2024-02-27
Completion
2024-02-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05667662 on ClinicalTrials.gov