In:
Otolaryngology–Head and Neck Surgery, Wiley, Vol. 151, No. S1 ( 2014-09)
Abstract:
Determine the safety and efficacy of SPI‐1005, a novel oral glutathione peroxidase (GPx) mimic and inducer, in preventing and treating noise‐induced hearing loss (NIHL) in adults ranging from slight hearing loss (≤25 dBHL) to normal hearing. Methods: Randomized double blind placebo controlled Phase 2 clinical trial conducted December 2012 through November 2013. A total of 83 subjects at the University of Florida were enrolled and treated with either placebo or SPI‐1005 prior to a single iPod sound exposure lasting 4 hours that induced a slight temporary threshold shift (TTS). The incidence (≥10 dBHL), severity (dBHL), and duration (up to 1 week post sound) of the TTS were determined by serial pure tone audiometry. The intervention (200, 400, or 600 mg SPI‐1005 twice daily × 4 days) was compared with matching placebo in reducing the TTS. Significance was determined by 2‐tailed t tests comparing a specific SPI‐1005 treatment group versus placebo. Results: Oral SPI‐1005 treatment showed a significant reduction in TTS incidence (60% vs 20%, P 〈 . 01), severity (4.2 vs 1.1 dBHL at 4 kHz, P 〈 . 01), and duration (24 vs 1.3 hours, P 〈 . 01). SPI‐1005 treatment was well tolerated with no drug‐related adverse events (CBC, Chem20, chest x‐ray). Conclusions: SPI‐1005 treatment demonstrated clinically relevant reductions in TTS induced by loud sound exposure. Multiday treatment with all SPI‐1005 dosages was well tolerated. These data support the continued development of SPI‐1005 in noise exposed populations and the GPx mechanism of action in preventing and treating NIHL.
Type of Medium:
Online Resource
ISSN:
0194-5998
,
1097-6817
DOI:
10.1177/0194599814541627a172
Language:
English
Publisher:
Wiley
Publication Date:
2014
detail.hit.zdb_id:
2008453-5
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