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Study to Evaluate Itraconazole Administered as Inhaled Dry Powder in Adults With Asthma and ABPA | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT05667662•Pulmatrix Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Is a male or female, ≥18 years old at the time of signing the informed consent.
•BMI of ≥18.0 and \<40.0 kg/m2 at screening.
•Has a diagnosis of asthma, as per the Global Initiative for Asthma (GINA) 2018 update
•Has a confirmed diagnosis of ABPA, based on the modified International Society for human and Animal Mycology (ISHAM) ABPA working group 2013 and 2021 criteria including a history of or documentation at screening of serum IgE ≥ 500 IU/mL and A. fumigatus-specific IgE\>0.35KUA/L, or above normal IgE antibody to A. fumigatus, or a positive immediate skin test and at least 2 of the 3 following supportive criteria: eosinophil count \>500 cells/µL; A. fumigatus-specific IgG \>27 mgA/L or presence of precipitating (or above normal immunoglobulin G \[IgG\]) antibody to A. fumigatus; consistent radiographic opacities or bronchiectasis on chest CT.
•Is currently considered to be in one of the following stages of ABPA: Stage 2 (Response), Stage 4 (Remission), Stage 5a (Treatment-dependent ABPA), or Stage 5b (Glucocorticoid-dependent asthma).
•At least 1 exacerbation requiring a systemic glucocorticosteroid(s) in the 12 months prior to Screening. For patients on a biologic agent, at least one exacerbation requiring a systemic glucocorticosteroid(s) must have occurred at least 3 months after the initiation of the biologic agent.
•Has a serum IgE ≥500 IU/mL at screening.
•Has a documented stable asthma medication regimen during the 28 days prior to the first dose of study drug ; applicable asthma medications can include but are not limited to the following: inhaled short-acting beta agonist (SABA), inhaled long-acting beta agonist (LABA), and leukotriene receptor antagonist (LTRA) use and inhaled and/or oral glucocorticosteroids. SABA use during this period should be mostly within a stable range (e.g., 2 puffs 2 to 4 times a day) and should not exceed 8 puffs a day on 2 out of 3 consecutive days.
•Can perform a valid, reproducible spirometry test with demonstration of a prebronchodilator FEV1 ≥50% of predicted normal for age, sex, race, and height at a screening visit.
•Can demonstrate the correct inhalation technique and achieve a minimum inspiratory flow rate of 45 L/min for the use of the delivery device at screening and before dosing on Day 1.
+2 more criteria

Exclusion Criteria

•Currently requiring medications that are sensitive substrates for CYP3A4-mediated metabolism or medications that are contraindicated with oral itraconazole.
•Has evidence of ventricular dysfunction, such as congestive cardiac failure (New York Heart Association functional class III or IV), or a history of congestive cardiac failure. N-terminal pro B-type natriuretic peptide (NT pro BNP) will be checked at screening only. A subject with a confirmed value of \>400 pg/mL will not be eligible to participate.
•Has used any systemic azole antifungal agent in the 6 weeks before first dose of study drug.
•Has discontinued previously administered biologic agent(s) in the 3 months prior to screening.
•Has a history of life-threatening asthma within the last 24 months, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, and/or hypoxic seizures.
•Has a current diagnosis of any chronic airway disease other than asthma, ABPA, or bronchiectasis believed to be related to ABPA, such as chronic obstructive pulmonary disease, pulmonary fibrosis, cystic fibrosis, or Churg-Strauss syndrome. A subject whose predominating clinical disease burden is related to bronchiectasis (e.g., a subject with 2 or more infective exacerbations of bronchiectasis in the past 12 months or a subject with chronic colonization with Pseudomonas aeruginosa) will be excluded. Refer to Appendix 4 for definition of bronchiectasis exacerbations.
•Had an occurrence of clinically significant bacterial, viral, or fungal infection that required systemic (oral or intravenous) antibiotics, antivirals, or antifungals within the 28 days before screening. Topical treatments, other than antifungals, are allowed.
•Had an occurrence of asthma or ABPA exacerbations within the 28 days before screening.
•Has the presence of hoarseness or oropharyngeal candidiasis at screening.
•Had a major trauma or surgery within the last 28-days before screening.
+17 more criteria

Locations (18)

University of Alabama Medical Center at Birmingham

Birmingham, Alabama, United States

Medical Research of Arizona

Scottsdale, Arizona, United States

Jonathan Corren, MD

Santa Monica, California, United States

Bensch Clinical Research

Stockton, California, United States

Southern Illinois University Center for Clinical Research

Springfield, Illinois, United States

University of Kansas Medical Center Research Institute

Kansas City, Kansas, United States

Baylor University Medical Center

Dallas, Texas, United States

UTMB Health

Galveston, Texas, United States

Westmead Hospital

Westmead, New South Wales, Australia

Mater Hospital Brisbane, Respiratory Research Group

South Brisbane, Queensland, Australia

Key Dates

Start Date

February 1, 2023

Primary Completion Date

February 27, 2024

Completion Date

February 27, 2024

Last Updated

April 2, 2024

Enrollment

ACTUAL participants

Conditions

ABPA

Interventions

Itraconazole Powder

DRUG

Placebo

DRUG

A Cohort Study of the Efficacy and Safety of Biologics in Patients With ABPA

NCT07362693

ABPABiologics+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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