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Equine veterinary journal2021; 53(6); 1094-1104; doi: 10.1111/evj.13419

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

Abstract: 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. Objective: To assess the effectiveness and safety of inhaled ciclesonide for the treatment of severe equine asthma. Methods: 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. Conclusions: 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.
© 2021 Boehringer Ingelheim Vetmedica GmbH. Equine Veterinary Journal published by John Wiley & Sons Ltd on behalf of EVJ Ltd.
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Publication Date: 2021-01-28 PubMed ID: 33403727PubMed Central: PMC8518630DOI: 10.1111/evj.13419Google Scholar: Lookup
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  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial
  • Veterinary

Summary

This research summary has been generated with artificial intelligence and may contain errors and omissions. Refer to the original study to confirm details provided. Submit correction.

This research paper reports the successful use of inhaled ciclesonide, a glucocorticoid prodrug, in treating severe equine asthma in a large-scale European trial. The study found that the treatment was effective, reducing clinical signs of asthma, and was well tolerated by the horses.

Research Objective and Methodology

  • The primary objective of this study was to evaluate the effectiveness and safety of inhaled ciclesonide for the treatment of severe equine asthma.
  • The research was conducted in a prospective, multicentre, placebo-controlled, randomized, double-blinded trial involving 224 horses with severe equine asthma from various locations.
  • The horses were divided into two groups at a 1:1 ratio: those receiving the ciclesonide inhalation (343 µg/actuation) solution and those receiving a placebo (0 µg/actuation).
  • The ciclesonide or placebo was administered using a non-pressurized inhaler designed specifically for horses, with initial daily doses of 8 actuations for the first 5 days and then once daily doses of 12 actuations for the next 5 days.
  • The primary outcome for the study was defined as a 30% or greater reduction in the horse’s Weighted Clinical Score (WCS) between the start of the study (Day 0) and Day 10.

Key Findings of the Study

  • The ciclesonide treatment was successful in 73.4% (80 out of 109) of the horses after 10 days of treatment. This success rate was significantly higher than the 43.2% (48 out of 111) success rate of the placebo group.
  • Few systemic and local adverse effects of ciclesonide were observed, demonstrating that the treatment was well-tolerated by the horses.
  • The placebo-treated group also showed relatively high success rates, indicating a potential placebo effect, which the researchers hypothesize could partially contribute to the improvement seen in the ciclesonide-treated group.
  • The clinical signs of severe equine asthma were observed to vary over time, which further complicated the interpretation of the treatment’s effectiveness.

Research Conclusions

  • In conclusion, this study demonstrated that administering ciclesonide by inhalation using the Aservo® EquiHaler® effectively reduced the severity of clinical signs in a majority of horses with severe equine asthma.
  • The treatment was well-tolerated and showed promising potential for use in real-world, field conditions outside of the controlled conditions of prior studies.
  • However, the presence of a notable placebo effect and the observed variability in the severity of clinical signs over time highlight the need for further studies to accurately define and understand the drug’s effectiveness.

Cite This Article

APA
Pirie RS, Mueller HW, Engel O, Albrecht B, von Salis-Soglio M. (2021). Inhaled ciclesonide is efficacious and well tolerated in the treatment of severe equine asthma in a large prospective European clinical trial. Equine Vet J, 53(6), 1094-1104. https://doi.org/10.1111/evj.13419

Publication

Equine veterinary journal
ISSN: 2042-3306
NlmUniqueID: 0173320
Country: United States
Language: English
Volume: 53
Issue: 6
Pages: 1094-1104

Researcher Affiliations

Pirie, Robert Scott
  • Royal (Dick) School of Veterinary Studies, University of Edinburgh, Easter Bush Veterinary Centre, Roslin, UK.
Mueller, Hanns-Walter
  • Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.
Engel, Odilo
  • Boehringer Ingelheim Vetmedica GmbH, Ingelheim, Germany.
Albrecht, Balazs
  • Boehringer Ingelheim Vetmedica GmbH, Ingelheim, Germany.
von Salis-Soglio, Marcella
  • Boehringer Ingelheim Vetmedica GmbH, Ingelheim, Germany.

MeSH Terms

  • Administration, Inhalation
  • Animals
  • Asthma / drug therapy
  • Asthma / veterinary
  • Double-Blind Method
  • Horse Diseases / drug therapy
  • Horses
  • Pregnenediones
  • Prospective Studies
  • Treatment Outcome

Grant Funding

  • Boehringer Ingelheim Vetmedica GmbH

Conflict of Interest Statement

B. Albrecht, O. Engel and M. von Salis‐Soglio are employees of Boehringer Ingelheim Vetmedica GmbH, the marketing authorisation holder of Aservo® Equihaler® with ciclesonide as active ingredient. H.‐W. Mueller is an employee of Boehringer Ingelheim Pharma GmbH & Co KG. R.S. Pirie has acted as consultant to Boehringer Ingelheim Vetmedica GmbH. B. Albrecht is co‐inventor on a patent regarding the use of ciclesonide in horses.

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Citations

This article has been cited 8 times.
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