dexamethasone

Verification of the Efficacy/Safety of the Dual Drug Delivery for Hearing Loss

March 1, 2021

https://clinicaltrials.gov/ct2/show/NCT04766853

Verification of the Efficacy/Safety of the Dual Drug Delivery for Hearing Loss

Brief Summary:
This study is a prospective, randomized pilot study. To verify an efficacy and safety of the dual drug injectable delivery vehicle, patients who have not responded to the existing standard treatment will be enrolled. Hearing test and endoscopy of tympanic membrane will be conducted after intratympanic treatment for evaluation.

Condition or disease Intervention/treatment Phase
Hearing Loss, Sudden
Hearing Loss Ototoxic
Hearing Loss, Noise-Induced
Meniere Disease
Drug: Dexamethasone
Drug: Hyaluronic acid
Phase 1
Phase 2

Study Design
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Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Verification of the Efficacy / Safety of the Dual Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss (Pilot Study)
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Potential benefits of salvage intratympanic dexamethasone injection in profound idiopathic sudden sensorineural hearing loss

April 15, 2020

https://link.springer.com/article/10.1007%2Fs00405-020-05967-z

https://www.ncbi.nlm.nih.gov/pubmed/32296977?dopt=Abstract

Potential benefits of salvage intratympanic dexamethasone injection in profound idiopathic sudden sensorineural hearing loss.

Eur Arch Otorhinolaryngol. 2020 Apr 15;:

Authors: Choi JW, Lee CK, Kim SB, Lee DY, Ko SC, Park KH, Choi SJ

Abstract

PURPOSES: To compare hearing recovery levels after initial treatment or salvage intratympanic dexamethasone injection (ITDI), and to find the prognostic factor on salvage ITDI therapy in profound ISSNHL.

METHODS: We retrospectively reviewed 115 patients with profound ISSNHL. All patients were treated with combination or systemic steroid therapy as the initial treatment. Next, we used salvage ITDI therapy on patients who showed slight or no improvement according to Siegel’s criteria. To find the prognostic factors for the effectiveness of salvage ITDI therapy, we analyzed clinical data, such as, age, sex, vertigo, symptom duration, diabetes, hypertension, initial PTA, pre-salvage PTA, and treatment methods, using multiple regression analyses.

RESULTS: The rate of serviceable hearing recovery were 10.4% (12/115) in the initial-treatment group and 20.4% (21/103) in the salvage group. The difference was statistically significant (p = 0.041). Pre-salvage PTA, diabetes mellitus, and symptom duration were affective factors for the effectiveness of salvage ITDI therapy in profound ISSNHL refractory to initial treatment, with odds ratios of 1.169 (95% confidence interval, 1.088-1.256), 0.069 (95% confidence interval, 0.005-0.889), and 9.242 (95% confidence interval, 1.079-79.146).

CONCLUSIONS: Salvage therapy should be considered for profound ISSNHL, which is expected to result in poor prognosis or hearing recovery: ITSI therapy might be an effective treatment as salvage therapy.

PMID: 32296977 [PubMed – as supplied by publisher]

High Dose Oral Steroids in Sudden Sensorineural Hearing Loss [Suspended] (On hold due to COVID-19 outbreak)

April 8, 2020

https://clinicaltrials.gov/ct2/show/NCT03255473

High Dose Oral Steroids in Sudden Sensorineural Hearing Loss

Study Type : Interventional
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Compare hearing outcomes between treatment with dexamethasone versus prednisone in participants who have been diagnosed with unilateral SSNHL within six weeks, and compare side effect profiles between the two treatment regimens of either dexamethasone or prednisone.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Oral Steroids in Sudden Sensorineural Hearing Loss
Actual Study Start Date : August 30, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : February 2020

Intratympanic Triamcinolone Acetonide as Treatment Option for Idiopathic Sudden Sensorineural Hearing Loss

June 14, 2019

https://journals.lww.com/otology-neurotology/Abstract/2019/07000/Intratympanic_Triamcinolone_Acetonide_as_Treatment.4.aspx

https://www.ncbi.nlm.nih.gov/pubmed/31192900?dopt=Abstract

Intratympanic Triamcinolone Acetonide as Treatment Option for Idiopathic Sudden Sensorineural Hearing Loss.

Otol Neurotol. 2019 Jul;40(6):720-727

Authors: Dahm V, Nieratschker M, Riss D, Kaider A, Auinger A, Honeder C, Arnoldner C

Abstract

INTRODUCTION: Corticosteroids represent the most commonly used treatment option for patients with idiopathic sudden sensorineural hearing loss. In the past, these compounds were mainly formulated and tested for intravenous or oral administration. Intratympanic application is increasingly being used, often as salvage treatment. The most suitable corticosteroid for local application has yet to be identified. Trials have suggested that triamcinolone acetonide has superior molecular properties for this treatment modality.

METHODS: The main aim of this study was to retrospectively assess the first audiometric results of patients diagnosed with idiopathic sudden sensorineural hearing loss and treated simultaneously with systemic prednisolone and intratympanic triamcinolone acetonide. This data was then compared to systemic treatment only, as well as to historic cohorts treated intratympanically with widely used corticosteroids, namely dexamethasone or methylprednisolone.

RESULTS: 90 patients received intravenous prednisolone only, and 89 individuals underwent intravenous treatment combined with three to four simultaneous intratympanic applications of triamcinolone. Eight patients received intratympanic triamcinolone as first-line treatment. After adjusting data for sex, time since onset, age, and severity of hearing loss, no statistically significant difference between the two main treatment groups could be identified. No major adverse events were observed, specifically no otitis media or persistent vertigo. Two perforated tympanic membranes healed spontaneously within several days.

CONCLUSION: While the exact role of intratympanic injections requires additional trials, triamcinolone resulted in similar outcomes compared to studies using dexamethasone or methylprednisolone. Due to favorable pharmacological properties, triamcinolone represents a safe and efficacious alternative for intratympanic treatment in idiopathic sensorineural hearing loss.

PMID: 31192900 [PubMed – in process]