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

NCT02396225 | Terminated DMC

• 1 other identifier: M-2013-242-13
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Invasive Aspergillosis

Keywords

voriconazole; inhalation; aerosol; epithelial lining fluid; concentration; pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• Voriconazole concentration in serum

  2 years

Secondary Outcomes (1)

• Voriconazole concentration in lunge epithelial lining fluid

  2 years

Study Arms (2)

Inhaled voriconazole

EXPERIMENTAL

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

Drug: Voriconazole

Oral Voriconazole

ACTIVE COMPARATOR

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

Interventions

Voriconazole DRUG

Inhaled voriconazole; Oral Voriconazole

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 24, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

DK (1)