NCT07283497 Itraconazole Therapy In Bronchiectasis With Airway Mold
| NCT ID | NCT07283497 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mayo Clinic |
| Condition | Bronchiectasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-06-20 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2026-06-20 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Amjad Kanj, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT07283497 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bronchiectasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07283497 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07283497 currently recruiting?
Yes, NCT07283497 is actively recruiting participants. Contact the research team at McNamara.Jennifer2@mayo.edu for enrollment information.
Where is the NCT07283497 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT07283497 clinical trial?
NCT07283497 is sponsored by Mayo Clinic. The principal investigator is Amjad Kanj, MD at Mayo Clinic. The trial plans to enroll 30 participants.