Inhaled ciclesonide in the treatment of severe asthma

The standard for the treatment of severe asthma (RAO or COPD) remains injectable dexamethasone. It is effective, cheap, easy to administer, and despite much of what you hear has a good safety profile. For more see the article associated with this topic. Here is presented another way to administer an inhaled steroid. By using inhalation administration, lower doses are possible, which may improve the safety profile. In return this is a much more expensive and treatment intensive program.
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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. doi: 10.1111/evj.13419. Online ahead of print.
Authors
R S Pirie 1 , H-W Mueller 2 , O Engel 3 , B Albrecht 3 , M von Salis-Soglio 3
Affiliations

1 Royal (Dick) School of Veterinary Studies, University of Edinburgh, Easter Bush Veterinary Centre, Roslin, EH25 9RG, UK.
2 Boehringer Ingelheim Pharma GmbH & Co KG, 55216, Ingelheim, Germany.
3 Boehringer Ingelheim Vetmedica GmbH, 55216, Ingelheim, Germany.

Abstract

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 non-pressurised Soft Mist™ inhaler specifically developed for horses (Aservo® EquiHaler® ) at doses of 8 actuations twice daily for the first five days and 12 actuations once daily for the following five 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.