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Study in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis

NCT03960606 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-08-27

No results posted yet for this study

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

Conditions

  • Allergic Bronchopulmonary Aspergillosis

Interventions

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

Sponsors & Collaborators

  • Pulmatrix Inc.

    lead INDUSTRY

Principal Investigators

  • William J. Calhoun, MD · University of Texas Medical Branch Galveston, TX 77555

  • David Denning, FRCP, FRC Path, FIDSA, FMedSci · Director, National Aspergillosis Centre Manchester, Wythenshawe M23 9LT, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2020-07-14
Completion
2020-07-14
FDA Drug
Yes

Countries

  • United States
  • Australia
  • India
  • Poland
  • United Kingdom

Study Locations

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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 NCT03960606 on ClinicalTrials.gov