Abstract
BackgroundTreatment of infected otitis externa (OE) relies on the topical application of specific formulations that most often contain an antibiotic, an antifungal and a glucocorticoid. This study is to report the results of a randomized, placebo-controlled field trial evaluating the efficacy and safety of OSURNIA™ (Elanco Animal Health, a division of Eli Lilly and Company, Greenfield, IN), a novel topical ear medication containing florfenicol, terbinafine and betamethasone acetate in an adaptable gel. The study includes 284 dogs with bacterial and/or fungal OE who were randomly assigned to receive two doses of Osurnia or its vehicle, one week apart. Dogs were evaluated at various time points through Day 45, and a total clinical score (TCS) was calculated based on pain, erythema, exudate, swelling, odor and ulceration. The primary outcome measure was the rate of treatment success (RTS), defined as a TCS of 0, 1 or 2 on Day 45. Before and after treatment, a “clap test” was performed to subjectively assess hearing, and blood and urine were collected for routine clinical pathology.ResultsThe RTS was significantly higher in ears treated with Osurnia (64.78%) than with placebo (43.42%). There was no significant interaction between efficacy and duration of history, recurrence of otitis or body weight. Adverse events were similar between groups. All dogs treated with Osurnia maintained their hearing, and there were no relevant clinical pathology changes.ConclusionsThe application of two doses of Osurnia, one week apart, is effective and safe to treat microbial otitis externa in dogs.
Highlights
Treatment of infected otitis externa (OE) relies on the topical application of specific formulations that most often contain an antibiotic, an antifungal and a glucocorticoid
Otitis externa is a syndrome characterized by inflammation of the external ear canal; it is traditionally attributed to a combination of predisposing, primary, perpetuating and secondary factors [3]
64/284 of the total dogs enrolled (23%) exited the trial early primarily due to lack of efficacy (n = 51) followed by adverse events (n = 8) and loss to follow-up (n = 5). These early exits represented 31/94 (33%) of the dogs with ears treated with placebo and 33/ 190 (17%) of those with an ear treated with Osurnia
Summary
Treatment of infected otitis externa (OE) relies on the topical application of specific formulations that most often contain an antibiotic, an antifungal and a glucocorticoid. Otitis externa is one of the most common medical conditions affecting dogs. In one epidemiological study of more than 2300 canine general practice consultations, a dermatological problem (21%) was the second most frequent reason motivating owners to consult their veterinarians after preventive veterinary care [1]. Otitis externa is a syndrome characterized by inflammation of the external ear canal; it is traditionally attributed to a combination of predisposing (e.g. ear canal conformation, moisture, etc.), primary (e.g. allergic, parasitic, foreign bodies, etc.), perpetuating (e.g. hyperplasia, stenosis, etc.) and secondary (e.g. bacteria, yeast infections, etc.) factors [3]. The impact of OE is notable, as otitis diminishes the quality of life of dogs and their owners [6]
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