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

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.

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