Publications by authors named "Hanns-Walter Mueller"

2 Publications

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Inhaled ciclesonide is efficacious and well tolerated in the treatment of severe equine asthma in a large prospective European clinical trial.

Equine Vet J 2021 Jan 5. Epub 2021 Jan 5.

Boehringer Ingelheim Vetmedica GmbH, Ingelheim, Germany.

Background: Ciclesonide is a glucocorticoid prodrug, already registered for human use. Due to its mode of action and inhaled route of administration, it was considered an appropriate treatment option for horses with severe equine asthma. Although the efficacy of inhaled ciclesonide has been demonstrated in horses with asthma exacerbations under controlled mouldy hay challenge conditions, it has not yet been reported under field conditions.

Objectives: To assess the effectiveness and safety of inhaled ciclesonide for the treatment of severe equine asthma.

Study Design: Prospective, multicentre, placebo-controlled, randomised, double-blinded study.

Methods: Two-hundred and twenty-four client-owned horses with severe equine asthma were randomised (1:1 ratio) to receive either ciclesonide inhalation (343 µg/actuation) solution or placebo (0 µg/actuation). Treatments (placebo or ciclesonide) were administered with a nonpressurised Soft Mist™ inhaler specifically developed for horses (Aservo EquiHaler ) at doses of 8 actuations twice daily for the first 5 days and 12 actuations once daily for the following 5 days. Primary outcome was a success/failure analysis with the a priori definition of treatment success as a 30% or greater reduction in weighted clinical score (WCS) between Day 0 and Day 10 (±1).

Results: The treatment success rate (as defined above) in ciclesonide-treated horses was 73.4% (80/109) after 10 (±1) days of treatment, being significantly higher than in the placebo group with 43.2% (48/111; P < 0.0001). Few systemic and local adverse events of ciclesonide were observed.

Main Limitations: The severity of clinical signs of severe equine asthma varies over time; despite the prohibition of environmental management changes during the study, a placebo effect was also identified. This potentially contributed, in part, to the clinical improvement observed in the ciclesonide-treated group.

Conclusions: Ciclesonide inhalation solution administered by the Aservo EquiHaler effectively reduced severity of clinical signs in a majority of horses with severe equine asthma and was well tolerated.
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January 2021

Development and Psychometric Validation of the Lincoln Canine Anxiety Scale.

Front Vet Sci 2020 3;7:171. Epub 2020 Apr 3.

Boehringer Ingelheim Vetmedica GmbH, Ingelheim am Rhein, Germany.

Anxiety in dogs, especially in relation to certain noises, is a common issue which can lead to clinically significant problems like noise phobias. While several scales have been used to assess sound sensitivity and reactivity, clinical monitoring has tended to depend on unvalidated methods, general assessment, and/or historical comparison with owners' recall of previous episodes. Therefore, we aimed to develop and validate a scale to assess canine anxiety. We used the data from 226 dogs from a previously reported double blind placebo controlled study in order to determine the validity of the 16 item "Lincoln Canine Anxiety Scale." Unidimensionality was assessed through correlation between individual item scores and total score, with internal consistency assessed using Cronbach's alpha. Factor analysis was used to determine the dimensionality of the scale. Item response theory (IRT) was used to gain insight into the value of single items to the overall scale scores. To characterize the score characteristics in an anxiety-eliciting context we analyzed the behaviors of placebo treated dogs assessed at 00:20 h, the time point of maximum noise stimulus during New Year's Eve fireworks. Sensitivity of the scale to treatment effects was determined from its performance in the wider study. The majority of correlations between individual items and total score were >0.48, with Cronbach's alpha equalling 0.88, indicating good internal consistency. Principal Component Analysis (PCA) confirmed a unidimensional structure. IRT indicated that the scale could be reduced to 11 items without significantly reducing its value. The scale showed good treatment and stimulus sensitivity, with a score change of ~20 points differentiating "no/worse" effect from an "excellent" effect and a 30% difference between treatment (imepitoin) and placebo. In our initial validation the Lincoln Canine Anxiety Scale appears to provide a reliable method for determining anxiety and fear responses by dogs and monitoring the effects of treatment.
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April 2020