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Trial record 25 of 58 for:    "Aspergillosis" | "Cytochrome P-450 CYP3A Inhibitors"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02396225
Recruitment Status : Terminated (results obtained at interrim analysis after 12 patients would not be changed by recruiting another twelwe participants)
First Posted : March 24, 2015
Last Update Posted : May 9, 2017
Aarhus University Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Invasive Aspergillosis Drug: Voriconazole Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Study Start Date : March 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Arm Intervention/treatment
Experimental: Inhaled voriconazole
12 patients inhale voriconazole 40 mg b.i.d for two days
Drug: Voriconazole
Active Comparator: 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
Drug: Voriconazole

Primary Outcome Measures :
  1. Voriconazole concentration in serum [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Voriconazole concentration in lunge epithelial lining fluid [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02396225

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Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital

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Responsible Party: University of Aarhus Identifier: NCT02396225     History of Changes
Other Study ID Numbers: M-2013-242-13
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Keywords provided by University of Aarhus:
epithelial lining fluid
Additional relevant MeSH terms:
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Cytochrome P-450 CYP3A Inhibitors
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs