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

Not Applicable

Terminated

• Conditions: Invasive Aspergillosis
• Interventions: Drug: Voriconazole

• Registration Number: NCT02396225
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-24
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaled voriconazole	Voriconazole	12 patients inhale voriconazole 40 mg b.i.d for two days
Oral Voriconazole	Voriconazole	12 patients ingest voriconazole tablets 400 mg b.i.d for one day followed by 200 mg b.i.d for one day

Primary Outcome Measures

Name	Time	Method
Voriconazole concentration in serum	2 years

Secondary Outcome Measures

Name	Time	Method
Voriconazole concentration in lunge epithelial lining fluid	2 years

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus C, Denmark