Itraconazole Therapy In Bronchiectasis With Airway Mold
Itraconazole Therapy In Bronchiectasis With Airway Mold: A Single-Arm Pilot Trial Of Feasibility, Safety, And Impact On Respiratory Symptoms And Airway Microbiome Diversity
Mayo Clinic
30 participants
Mar 15, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria8
- 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
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Interventions
Subjects will receive oral itraconazole, 200 mg twice daily, for six weeks, based on prior dosing regimens for airway fungal disease.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07283497