Triamcinolone Levels in Cochlear Perilymph

In this study Triamcinolone acetonide will be applied intratympanically before cochlear implant surgery. After round window exposure, a perilymph sample and simultaneously a blood sample will be drawn. Triamcinolone levels will then be analyzed in the samples.

Study Overview

• Status: Completed
• Conditions: Cochlear Hearing Loss
• Intervention / Treatment: Drug: Triamcinolone Acetonide

Detailed Description

At the ENT department of the university hospital Vienna (AKH Wien) patients are treated with intratympanic triamcinolone acetonide before cochlea implantation to reduce inflammation and in some cases to protect residual hearing. Triamcinolone acetonide levels in cochlear perilymph will be evaluated in an open prospective clinical study. Patients scheduled for cochlear implant surgery between 18 and 90 years will be included. Patients who are treated with steroids preoperatively will be excluded from the study. Patients will be randomized after inclusion to one of four groups. The randomization is carried out to generate hypothesis for the needed dose and best time of application in the future. Triamcinolone acetonide will then be applied 20-24h before surgery or at the beginning of the surgery, depending on randomization (see below). About 20 µl of perilymph will be sampled simultaneously to a blood sample during cochlear implant surgery.

The probes will be stored at -80°C. Triamcinolone acetonide levels of the blood and perilymph will be determined by the pharmaceutical laboratory (Department of Pharmaceutical Technology and Biopharmaceutics, University of Vienna).

The patients will be randomized to 4 groups. Group 1 - Volon A 10mg administration 20 - 24 hours before sampling. Group 2 - Volon A 40mg administration 20 - 24 hours before sampling. Group 3 Volon A 10mg - administration 1 to 2 hours before sampling. Group 4 - Volon A 40mg administration 1 to 2 hours before sampling.

The time interval of application (1 to 2 hours and 20 to 24 hours before sampling) are a result of varying time of surgery depending on surgeons and patient anatomy as well as day to day clinical organization. Patients can withdraw consent at any time of the study.

The active phase of each patient will be between 6 and 9 days depending on time of follow-up visit.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna (AKH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients between 18 and 90 years will be included in the study, who will undergo a cochlear implantation and are willing to participate in the study

Exclusion Criteria:

• Patients younger than 18 years
• Patients who receive cortisone on a regular basis or receive cortisone i.v. or p.o. preoperatively
• Patients with contraindications against the administration of Volon A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1; Group 1 will receive triamcinolone acetonide 10mg 20 to 24hours before sampling.	Drug: Triamcinolone Acetonide; Intratympanic administration
Other: Group 2; Group 2 will receive triamcinolone acetonide 40mg 20 to 24hours before sampling.	Drug: Triamcinolone Acetonide; Intratympanic administration
Other: Group 3; Group 3 will receive triamcinolone acetonide 10mg 1 to 2 hours before sampling.	Drug: Triamcinolone Acetonide; Intratympanic administration
Other: Group 4; Group 3 will receive triamcinolone acetonide 40mg 1 to 2 hours before sampling.	Drug: Triamcinolone Acetonide; Intratympanic administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triamcinolone levels in comparison	Absorption of Triamcinolone acetonide in cochlear perilymph in comparison to dissemination to the blood circulation	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triamcinolone stability	The stability of triamcinolone acetonide levels in the cochlear perilymph	2 years
Triamcinolone concentrations	Perilymph concentrations and blood concentrations of triamcinolone acetonide after administration of different Triamcinolone acetonide doses.	2 years
Impedances	Difference of impedances of patients receiving different doses at different timepoints	2 years

Collaborators and Investigators

• Sponsor: Christoph Arnoldner

Publications and helpful links

General Publications

• Dahm V, Gausterer JC, Auinger AB, Honeder C, Gabor F, Reznicek G, Kaider A, Riss D, Arnoldner C. Evaluation of Levels of Triamcinolone Acetonide in Human Perilymph and Plasma After Intratympanic Application in Patients Receiving Cochlear Implants: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Nov 1;147(11):974-980. doi: 10.1001/jamaoto.2021.2492.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (Actual): August 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 25, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 1456/2017; 2017-002377-19 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: January 2020
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No