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Taking people in United StatesPhase 4

Itraconazole for bronchiectasis with mold in the airways

Tests itraconazole in adults with bronchiectasis and mold in their airways.

Key facts

Who runs it
Mayo Clinic
Where
Rochester, United StatesSee the site
Trial code
Registry title
Itraconazole Therapy In Bronchiectasis With Airway Mold
Status
Recruiting
Phase
Phase 4
People taking part
30 people, planned
Started
17 Aug 2026
Expected to end
31 Dec 2030
Type of study
Interventional
Treatments tested
  • Itraconazole 200 mg
Record updated
21 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with bronchiectasis (widened, damaged airways) whose sputum grew mold. All take itraconazole 200 mg.

Age
18 years and older
Sex
All sexes
Disease stage
Bronchiectasis confirmed by a clinic provider and chest CT, seen at the Mycobacterial and Bronchiectasis Clinic in Rochester. In the last 3 months, a culture grew a lot of mold or at least two different mold types. People must be able to cough up sputum at Visit 1.
Earlier treatment
Not currently on antimicrobial treatment and no plan to start it. No antifungal pills or injections in the past 3 months.
Biomarker or test result
Mold grown in a sputum culture within the last 3 months.

Main reasons for not taking part

  • Allergic bronchopulmonary aspergillosis or invasive fungal disease
  • Taking certain drugs, such as rifampin, simvastatin, tacrolimus, warfarin or apixaban
  • Abnormal liver tests or long QTc on ECG (>460 ms in females, >450 ms in males)
  • Heart failure, cardiomyopathy or heart rhythm problems
  • Pregnancy, breastfeeding, or allergy to azole antifungals

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • Prior use of systemic antifungals within the past 3 months
  • Known diagnosis of allergic bronchopulmonary aspergillosis or invasive fungal disease
  • History of congestive heart failure (black box warning), known cardiomyopathy, or arrhythmias
  • Known hypersensitivity or contraindication to azole antifungal therapy
  • 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)
  • Pregnancy or lactation

Where in United States

  • Mayo Clinic in RochesterRochester, United StatesContact: Pulmonary Clinical Research OfficeTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • BronchiectasisTreatment being tested

    Subjects with bronchiectasis and airway mold

    Treatment: Itraconazole 200 mg

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Itraconazole Therapy In Bronchiectasis With Airway Mold: A Single-Arm Pilot Trial Of Feasibility, Safety, And Impact On Respiratory Symptoms And Airway Microbiome Diversity
Plain-language title
Itraconazole for bronchiectasis with mold in the airwaysGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
21 August 2026