Preclinical profile of ciclesonide, a novel corticosteroid for the treatment of asthma

J Pharmacol Exp Ther. 2005 Aug;314(2):568-74. doi: 10.1124/jpet.105.085217. Epub 2005 May 5.

Abstract

Ciclesonide is a novel, inhaled corticosteroid under development for the treatment of asthma. Ciclesonide is activated to desisobutyryl-ciclesonide (des-CIC) in the lungs to provide potent anti-inflammatory activity. The investigations herein compared the activity of ciclesonide with fluticasone in animal models to assess efficacy/potency as an airway anti-inflammatory and the comparative side effect potential to consider the therapeutic ratio of each compound. In radioligand binding assays, des-CIC and fluticasone exhibited comparable high-affinity binding to the glucocorticoid receptor, whereas ciclesonide exhibited 100-fold less binding affinity. In the Brown Norway rat model of antigen-induced airway eosinophilia and in a model of Sephadex-induced lung edema, ciclesonide and fluticasone exhibited comparable efficacy. Interestingly, following 7-day intratracheal administration, ciclesonide elicited adrenal involution with a potency that was 44-fold less than fluticasone. Furthermore, ciclesonide was 22-fold less active than fluticasone in eliciting hypoplasia of the femoral growth plate. These data support the concept that ciclesonide acts as a parent compound that, when delivered to the airways, can be transformed into the active metabolite des-CIC, resulting in local high anti-inflammatory activity. Furthermore, ciclesonide possesses equivalent anti-inflammatory efficacy through pulmonary activation with a significantly improved safety profile in preclinical animal models compared with fluticasone.

Publication types

  • Comparative Study

MeSH terms

  • Adrenal Glands / drug effects
  • Androstadienes / pharmacology
  • Animals
  • Anti-Asthmatic Agents / pharmacokinetics
  • Anti-Asthmatic Agents / pharmacology*
  • Binding, Competitive / drug effects
  • Blood Proteins / metabolism
  • Bone Diseases, Metabolic / chemically induced
  • Bone Diseases, Metabolic / pathology
  • Dextrans
  • Eosinophils / drug effects
  • Eosinophils / pathology
  • Femur / drug effects
  • Femur / growth & development
  • Femur Head / drug effects
  • Femur Head / growth & development
  • Fluticasone
  • Growth Plate / drug effects
  • Inflammation / drug therapy
  • Inflammation / pathology
  • Pregnenediones / pharmacokinetics
  • Pregnenediones / pharmacology*
  • Protein Binding
  • Pulmonary Edema / chemically induced
  • Pulmonary Edema / drug therapy
  • Rats
  • Rats, Inbred BN
  • Rats, Sprague-Dawley
  • Receptors, Steroid / drug effects
  • Thymus Gland / drug effects
  • Thymus Gland / growth & development

Substances

  • Androstadienes
  • Anti-Asthmatic Agents
  • Blood Proteins
  • Dextrans
  • Pregnenediones
  • Receptors, Steroid
  • sephadex
  • Fluticasone
  • ciclesonide