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.

Study Overview

• Status: Recruiting
• Conditions: Bronchiectasis; Fungal Infection of Upper Respiratory Tract
• Intervention / Treatment: Drug: Itraconazole 200 mg

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Pulmonary Clinical Research Office; Phone Number: 800-753-1606; Email: McNamara.Jennifer2@mayo.edu
• Study Contact Backup: Name: Jennifer McNamara, BS; Phone Number: 507-266-6705; Email: McNamara.Jennifer2@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Pulmonary Clinical Research Office; Phone Number: 800-753-1606
      • Principal Investigator: Amjad Kanj, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bronchiectasis; Subjects with bronchiectasis and airway mold	Drug: Itraconazole 200 mg; Subjects will receive oral itraconazole, 200 mg twice daily, for six weeks, based on prior dosing regimens for airway fungal disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of eligible patients who consent and enroll	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%.	2 years
Number of patients to achieve successful medication adherence	Adherence will be assessed through pill counts with successful adherence defined as ≥ 70% of doses taken and achieving a therapeutic trough level.	2 years
Proportion of participants who complete treatment without adverse effects	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%.	2 years
Proportion of patients retained for complete study	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants meeting hepatic safety discontinuation criteria	Hepatic safety will be monitored with serial hepatic function panels obtained at baseline, day 7, with the endpoint defined as the number of participants meeting discontinuation criteria: total bilirubin more than 2 times the ULN according to Mayo laboratory reference, ALT more than two times the ULN, AST more than two times the ULN, or ALP greater than 250 U/L.	Baseline, 1 week
Number of participants with a QTc interval greater than 500 ms	Cardiac safety will be assessed by obtaining an ECG on day 7, with the endpoint defined as the proportion of participants with a QTc interval greater than 500 ms.	Baseline, 1 week

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Amjad Kanj, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Triazoles; Piperazines; Itraconazole
• Other Study ID Numbers: 25-010613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No