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

Primary Purpose

Invasive Aspergillosis

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Voriconazole
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Invasive Aspergillosis focused on measuring voriconazole, inhalation, aerosol, epithelial lining fluid, concentration, pharmacokinetic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inhaled voriconazole

Oral Voriconazole

Arm Description

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

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

Outcomes

Primary Outcome Measures

Voriconazole concentration in serum

Secondary Outcome Measures

Voriconazole concentration in lunge epithelial lining fluid

Full Information

First Posted
March 18, 2015
Last Updated
May 8, 2017
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02396225
Brief Title
Concentrations of Voriconazole in Blood and BAL-fluid After Inhalation and Oral Administration
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
results obtained at interrim analysis after 12 patients would not be changed by recruiting another twelwe participants
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Aspergillosis
Keywords
voriconazole, inhalation, aerosol, epithelial lining fluid, concentration, pharmacokinetic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaled voriconazole
Arm Type
Experimental
Arm Description
12 patients inhale voriconazole 40 mg b.i.d for two days
Arm Title
Oral Voriconazole
Arm Type
Active Comparator
Arm Description
12 patients ingest voriconazole tablets 400 mg b.i.d for one day followed by 200 mg b.i.d for one day
Intervention Type
Drug
Intervention Name(s)
Voriconazole
Primary Outcome Measure Information:
Title
Voriconazole concentration in serum
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Voriconazole concentration in lunge epithelial lining fluid
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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

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