Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07283497

Itraconazole Therapy In Bronchiectasis With Airway Mold

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Bronchiectasis Bronchial Diseases Fungal Infection of Upper Respiratory Tract Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Amjad Kanj, MD, MPH

PRINCIPAL_INVESTIGATOR

Pulmonary Clinical Research Office

CONTACT

800-753-1606

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Proportion of eligible patients who consent and enroll

    Time frame: 2 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%.

  2. Number of patients to achieve successful medication adherence

    Time frame: 2 years

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

  3. Proportion of participants who complete treatment without adverse effects

    Time frame: 2 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%.

  4. Proportion of patients retained for complete study

    Time frame: 2 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.

Secondary outcomes

  1. Number of participants meeting hepatic safety discontinuation criteria

    Time frame: Baseline, 1 week

    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.

  2. Number of participants with a QTc interval greater than 500 ms

    Time frame: Baseline, 1 week

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer McNamara, BS

CONTACT

[email protected]

507-266-6705

Pulmonary Clinical Research Office

CONTACT

[email protected]

800-753-1606

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Dec 15, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.