Concentrations of Voriconazole in Blood and BAL-fluid After Inhalation and Oral Administration

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02396225

Enrollment

Registered

2015-03-24

Start date

2015-03-31

Completion date

2016-12-31

Last updated

2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Aspergillosis

Keywords

voriconazole, inhalation, aerosol, epithelial lining fluid, concentration, pharmacokinetic

Brief summary

Concentrations of voriconazole in pulmonary epithelial lining fluid and in serum are compared after inhalation of 40 mg voriconazole b.i.d. for two days or oral intake of voriconazole tablets 400 mg bid for 1 day followed by 200 mg b.i.d. for one day, respectively.

Interventions

DRUGVoriconazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Planned bronchoscopy in relation to work-up after hemoptysis or other symptom leading to bronchoscopy * Informed written consent * Performance status 0-1 * Ct scan of thorax without suspicion of malignancy * Weight t ≥ 60 og ≤ 130 kg * Male gender or female gender in postmenopausal state defined by amenorrhea in more than 12 months.

Exclusion criteria

* Voriconazole treatment up to one week before inclusion * Se-creatinin≥ 100 uM * ALAT ≥ 70 U/l * QT-interval \> 480 ms * Allergic reaction to voriconazole or constituents in Vfend * Allergic reaction to other azoles * Ischemic Heart disease, Heart failure or uncontrolled hypertension * Treatment with statins or omeprazole, which cannot be paused for three days during voriconazole exposure * Treatment with Efavirenz, rifabutin, ritonavir, everolimus, methadon, alfentanil, fentanyl, sufentanil, oxycodone, hydrocodone, fluconazole, aztemizol, cisaprid, pimozid, quinidine, terfenadine, carbamazepine, phenobarbital, mephobarbital, ergotamine, dihydroergotamine, rifampicine, st. johns worth, everolimus, phenytoin, warfarin, phenprocoumon, acenocoumarol, benzodiazepines as midazolam, triazolam, alprazolam, sirolimus, cyclosporine, tacrolimus, ibuprofen, diclofenac,tolbutamide, glipizide, vincristine, vinblastine or other vinca alkaloids, HIV-protease Inhibitors e.g. saquinavir, amprenavir and nelfinavir, delavirdine, nivrapine and other non-nocleaoside revers transcriptase inhibitors

Design outcomes

Primary

Measure	Time frame
Voriconazole concentration in serum	2 years

Secondary

Measure	Time frame
Voriconazole concentration in lunge epithelial lining fluid	2 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026