Cochlear Hearing LossPhase 1NCT03248856
Triamcinolone Levels in Cochlear Perilymph
A Phase 1 study testing Triamcinolone Acetonide in people with Cochlear Hearing Loss, run by Christoph Arnoldner at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cochlear Hearing Loss
- What is being tested?
- Triamcinolone Acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 2 Oct 2017to 31 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cochlear Hearing Loss
- Being tested
- Triamcinolone Acetonide
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
Intratympanic administration
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Group 1 will receive triamcinolone acetonide 10mg 20 to 24hours before sampling. Receives: Drug: Triamcinolone Acetonide |
| Group 2 | Other | Group 2 will receive triamcinolone acetonide 40mg 20 to 24hours before sampling. Receives: Drug: Triamcinolone Acetonide |
| Group 3 | Other | Group 3 will receive triamcinolone acetonide 10mg 1 to 2 hours before sampling. Receives: Drug: Triamcinolone Acetonide |
| Group 4 | Other | Group 3 will receive triamcinolone acetonide 40mg 1 to 2 hours before sampling. Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triamcinolone levels in comparison
Absorption of Triamcinolone acetonide in cochlear perilymph in comparison to dissemination to the blood circulation
Measured: 2 years
Secondary outcomes (3)
Triamcinolone stability
The stability of triamcinolone acetonide levels in the cochlear perilymph
Measured: 2 years
Triamcinolone concentrations
Perilymph concentrations and blood concentrations of triamcinolone acetonide after administration of different Triamcinolone acetonide doses.
Measured: 2 years
Impedances
Difference of impedances of patients receiving different doses at different timepoints
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start2 Oct 2017
- Primary completion31 Dec 2020
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cochlear Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christoph Arnoldner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christoph Arnoldner, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248856
- Sponsor's protocol ID
- 1456/2017
- Other IDs
- 2017-002377-19, 2017
- Status last verified
- Sep 2021
- First submitted
- 9 Aug 2017
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 34591079
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triamcinolone Levels in Cochlear Perilymph
- ClinicalTrials.gov ID
- NCT03248856
- Acronym / sponsor ID
- 1456/2017
- Conditions
- Cochlear Hearing Loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Christoph ArnoldnerUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Drug: Triamcinolone AcetonideGroup 1 will receive triamcinolone acetonide 10mg 20 to 24hours before sampling. |
| Group 2 | Other | Drug: Triamcinolone AcetonideGroup 2 will receive triamcinolone acetonide 40mg 20 to 24hours before sampling. |
| Group 3 | Other | Drug: Triamcinolone AcetonideGroup 3 will receive triamcinolone acetonide 10mg 1 to 2 hours before sampling. |
| Group 4 | Other | Drug: Triamcinolone AcetonideGroup 3 will receive triamcinolone acetonide 40mg 1 to 2 hours before sampling. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone AcetonideIntratympanic administration | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Triamcinolone levels in comparison
Time frame: 2 years
Absorption of Triamcinolone acetonide in cochlear perilymph in comparison to dissemination to the blood circulation
3 secondary outcomes
Triamcinolone stability
Time frame: 2 years
Triamcinolone concentrations
Time frame: 2 years
Impedances
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Derived from this study: PubMed 34591079Dahm 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Triamcinolone Acetonide in people with Cochlear Hearing Loss, run by Christoph Arnoldner at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triamcinolone levels in comparison (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03248856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.