Itraconazole for 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
This study will try oral itraconazole in adults with bronchiectasis who have mold in their airways to see if people can take it safely and whether it changes symptoms and airway microbes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07283497 on ClinicalTrials.gov |
What this trial studies
This Phase 4, single-center interventional feasibility study gives adults with bronchiectasis and recent airway mold growth oral itraconazole 200 mg to test practical use in this population. Feasibility outcomes include recruitment success, medication adherence, tolerability, and participant retention. Exploratory outcomes include changes in respiratory symptoms and diversity of the airway microbiome measured from sputum. Participants are enrolled through the Mycobacterial and Bronchiectasis Clinic at Mayo Clinic in Rochester, Minnesota with eligibility confirmed by chest CT and recent sputum cultures.
Who should consider this trial
Good fit: Adults (≥18) seen at the Mycobacterial and Bronchiectasis Clinic with CT-confirmed bronchiectasis and recent sputum showing high mold growth or at least two distinct mold species, who are not actively on antibiotics and can produce spontaneous sputum, are ideal candidates.
Not a fit: Patients with allergic bronchopulmonary aspergillosis or invasive fungal disease, those taking contraindicated interacting medications, or those with abnormal baseline liver tests are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could offer a tolerable antifungal option that reduces respiratory symptoms and favorably alters the airway microbiome in patients with bronchiectasis and airway mold.
How similar studies have performed: Antifungal therapy has demonstrated benefits in allergic or invasive aspergillosis, but using itraconazole for non-ABPA bronchiectasis with airway mold is largely untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Amjad Kanj, MD — Mayo Clinic
- Study coordinator: Pulmonary Clinical Research Office
- Email: McNamara.Jennifer2@mayo.edu
- Phone: 800-753-1606
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.