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Itraconazole for Bronchiectasis with Airway Mold

This study is testing a medication called itraconazole (200 mg twice daily for six weeks) in people with bronchiectasis (a lung condition where airways are damaged and widened) who also have mold growing in their airways. The main goal is to see if it's practical to give this treatment, by looking at how many people join, how well they take the medicine, if they can tolerate it, and if they stay in the study. Researchers will also look at how itraconazole affects breathing symptoms and the types of germs in the airways. You might be able to join if you are at least 18 years old, have bronchiectasis, and have a recent culture showing mold in your airways. The study is currently unclear on its recruitment status and plans to enroll 30 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 30 participants.
What's involved
You would take oral itraconazole 200 mg twice daily for six weeks. The study will assess your adherence to this medication.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes like medication adherence and adverse effects over a period of 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07283497

Itraconazole Therapy In Bronchiectasis With Airway Mold

Recruiting
PHASE4Ages 18+InterventionalTreatment
Mayo Clinic
~30 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Itraconazole 200 mg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of eligible patients who consent and enroll
Measured over 2 years
+3 more outcomes measured

Conditions

Bronchiectasis
Fungal Infection of Upper Respiratory Tract

Explore related trials

BronchiectasisInfection of upper respiratory tract caused by fungus

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Amjad Kanj, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Pulmonary Clinical Research Office
[email protected]
800-753-1606
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Proportion of eligible patients who consent and enroll2 years

    Recruitment will be measured as the proportion of eligible patients who consent and enroll out of patients screened, reported as a percentage, with a benchmark of \>60%.

  • Number of patients to achieve successful medication adherence2 years

    Adherence will be assessed through pill counts with successful adherence defined as ≥ 70% of doses taken and achieving a therapeutic trough level.

  • Proportion of participants who complete treatment without adverse effects2 years

    Tolerability will be evaluated as the proportion of participants who complete the 6-week course without discontinuation due to adverse effects, with a target benchmark of ≥ 70%.

  • Proportion of patients retained for complete study2 years

    Retention will be defined as the proportion of participants completing all scheduled study visits (baseline, day 7 and end of treatment), with a goal of ≥ 80% retention.