Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 51 for:    "Invasive Aspergillosis" | "Anti-Infective Agents"

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.
ClinicalTrials.gov 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
Sponsor:
Collaborator:
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

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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 ClinicalTrials.gov identifier (NCT number): NCT02396225


Locations
Layout table for location information
Denmark
Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital

Layout table for additonal information
Responsible Party: University of Aarhus
ClinicalTrials.gov 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:
voriconazole
inhalation
aerosol
epithelial lining fluid
concentration
pharmacokinetic

Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Infective Agents
Aspergillosis
Mycoses
Voriconazole
Antifungal 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
Cytochrome P-450 CYP3A Inhibitors