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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Invasive Aspergillosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Inhaled voriconazole

12 patients inhale voriconazole 40 mg b.i.d for two days

Group Type EXPERIMENTAL

Voriconazole

Intervention Type DRUG

Oral Voriconazole

12 patients ingest voriconazole tablets 400 mg b.i.d for one day followed by 200 mg b.i.d for one day

Group Type ACTIVE_COMPARATOR

Voriconazole

Intervention Type DRUG

Interventions

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Voriconazole

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No