Itraconazole Therapy In Bronchiectasis With Airway Mold

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-15

Study Completion Date

2030-12-31

Brief Summary

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The primary objective of this study is to evaluate the feasibility of itraconazole therapy in patients with bronchiectasis and airway mold. Feasibility will be assessed through recruitment success, treatment adherence, tolerability, and participant retention. The study will also explore the impact on respiratory symptoms and airway microbiome diversity.

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Detailed Description

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Conditions

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Bronchiectasis Fungal Infection of Upper Respiratory Tract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bronchiectasis

Subjects with bronchiectasis and airway mold

Group Type EXPERIMENTAL

Itraconazole 200 mg

Intervention Type DRUG

Subjects will receive oral itraconazole, 200 mg twice daily, for six weeks, based on prior dosing regimens for airway fungal disease.

Interventions

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Itraconazole 200 mg

Subjects will receive oral itraconazole, 200 mg twice daily, for six weeks, based on prior dosing regimens for airway fungal disease.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years seen at Mycobacterial and Bronchiectasis Clinic (MMBC) in Rochester
* Diagnosis of bronchiectasis confirmed by MMBC provider and chest CT
* Within the last 3 months - culture growth of a mold in high quantity ('many') or culture growth of at least two distinct mold species in any quantity
* Not actively on antimicrobial therapy AND no current plan to initiate antimicrobial therapy at the time of enrollment, as determined by treating provider
* Ability to produce spontaneous sputum at Visit 1.

Exclusion Criteria

* Known diagnosis of allergic bronchopulmonary aspergillosis or invasive fungal disease
* Use of the following medications: rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, dofetilide, quinidine, dronedarone, simvastatin, lovastatin, certain immunosuppressants (tacrolimus, cyclosporine, sirolimus, everolimus) and anticoagulants (rivaroxaban, apixaban, edoxaban, warfarin).
* Abnormal baseline liver function tests (ALT, AST, alkaline phosphatase, or bilirubin \> upper limit of normal)
* Prolonged QTc interval on baseline ECG (\>460 ms in females or \>450 ms in males)
* History of congestive heart failure (black box warning), known cardiomyopathy, or arrhythmias
* Pregnancy or lactation
* Known hypersensitivity or contraindication to azole antifungal therapy
* Prior use of systemic antifungals within the past 3 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No