Itraconazole Therapy In Bronchiectasis With Airway Mold

NCT07283497 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 25-010613
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis; Fungal Infection of Upper Respiratory Tract

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Number of participants meeting hepatic safety discontinuation criteria

  Baseline, 1 week

• Number of participants with a QTc interval greater than 500 ms

  Baseline, 1 week

Study Arms (1)

Bronchiectasis

EXPERIMENTAL

Subjects with bronchiectasis and airway mold

Drug: Itraconazole 200 mg

Interventions

Itraconazole 200 mg DRUG

Subjects will receive oral itraconazole, 200 mg twice daily, for six weeks, based on prior dosing regimens for airway fungal disease.

Bronchiectasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Bronchiectasis

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Amjad Kanj, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pulmonary Clinical Research Office

CONTACT

800-753-1606; McNamara.Jennifer2@mayo.edu

Jennifer McNamara, BS

CONTACT

507-266-6705; McNamara.Jennifer2@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 15, 2025
• Study Start: March 15, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)