A Phase 4 interventional study of Itraconazole 200 mg in Bronchiectasis and Fungal Infection of Upper Respiratory Tract, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Treatment
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.
404 studies on the registry are indexed under Bronchiectasis; 125 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 263 interventional studies indexed under Bronchiectasis.
Browse Bronchiectasis studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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%.
Time frame: 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.
Time frame: 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%.
Time frame: 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.
Time frame: 2 years
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.
Time frame: 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.
Time frame: Baseline, 1 week
Plan to share: No
Started Aug 2026 (actual). Primary completion is estimated for Dec 2030, 52 months after the start.
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Studies of the drug tested here: Itraconazole