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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronchiectasis | Experimental | Subjects with bronchiectasis and airway mold |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pulmonary Clinical Research Office | Contact | 800-753-1606 | McNamara.Jennifer2@mayo.edu | |
| Jennifer McNamara, BS | Contact | 507-266-6705 | McNamara.Jennifer2@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amjad Kanj, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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 |
| D010879 |
| Piperazines |