title: Effectiveness of ciclesonide nasal spray in the treatment of seasonal allergic rhinitis.
abstract: BACKGROUND
  Ciclesonide is an investigational corticosteroid under development for treatment of allergic rhinitis. Ciclesonide is converted to active metabolite, desisobutyryl-ciclesonide (des-CIC), by upper and lower airway esterases. In vitro studies in human nasal epithelial cells and bronchial epithelial cells have demonstrated a long duration of anti-inflammatory activity of des-CIC.
  
  
  OBJECTIVE
  To evaluate the dose-dependent efficacy and safety of a hypotonic intranasal formulation of ciclesonide in patients with seasonal allergic rhinitis (SAR).
  
  
  METHODS
  This was a phase 2, randomized, parallel-group, double-blind, placebo-controlled study. Adults (n = approximately 145 per treatment group) with a minimum 2-year history of SAR received placebo or ciclesonide (25, 50, 100, or 200 microg/d) for 14 days. The primary end point was change in the sum of morning and evening reflective total nasal symptom scores (TNSSs) over 2 weeks. Safety was monitored throughout the study.
  
  
  RESULTS
  Ciclesonide, 100 microg/d (P = .04) and 200 microg/d (P = .003), significantly improved the sum of morning and evening reflective TNSS vs placebo at more than 2 weeks of treatment. Baseline values for morning and evening reflective TNSS ranged from 17.80 to 18.82 across treatment groups. The average change from baseline in reflective TNSS was -4.2 for placebo and -4.8, -4.8, -5.3, and -5.8 for ciclesonide, 25, 50, 100, and 200 microg/d, respectively. There were no dose-related differences in the incidence of adverse events among treatment groups.
  
  
  CONCLUSIONS
  Results from this study indicate that 100-microg and 200-microg daily doses of ciclesonide are effective in the treatment of SAR. Ciclesonide, 200 microg/d, appears to be the optimal dose studied for reducing the symptoms of SAR while maintaining an acceptable safety profile.
authors.affiliation: Sylvana Research, San Antonio, Texas 78229, USA. phratner@swbell.net
authors.forename: Paul H
authors.initials: PH
authors.lastname: Ratner
authors.forename: Mark A
authors.initials: MA
authors.lastname: Wingertzahn
authors.forename: Julius H
authors.initials: JH
authors.lastname: van Bavel
authors.forename: Frank
authors.initials: F
authors.lastname: Hampel
authors.forename: Patrick F
authors.initials: PF
authors.lastname: Darken
authors.forename: Stefan
authors.initials: S
authors.lastname: Hellbardt
authors.forename: Sheldon
authors.initials: S
authors.lastname: Brookman
authors.forename: Tushar
authors.initials: T
authors.lastname: Shah
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D010612:Pharyngitis / Q000139:chemically induced; D011282:Pregnenediones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018926:Anti-Allergic Agents; D011282:Pregnenediones; C120481:ciclesonide