title: Efficacy and safety of ciclesonide, 200 microg once daily, for the treatment of perennial allergic rhinitis.
abstract: BACKGROUND
  Ciclesonide is an intranasal corticosteroid approved for the treatment of allergic rhinitis (AR).
  
  
  OBJECTIVE
  To evaluate the efficacy, safety, and quality-of-life benefits of intranasal ciclesonide, 200 microg once daily, for the treatment of perennial AR (PAR).
  
  
  METHODS
  In this multicenter, randomized, double-blind, placebo-controlled study, adults and adolescents with at least a 2-year history of PAR received intranasal ciclesonide, 200 microg, or placebo once daily for 6 weeks. Patient-evaluated total nasal symptom scores (TNSSs), physician-assessed overall nasal signs and symptoms severity scores, and Rhinoconjunctivitis Quality of Life Questionnaire scores were evaluated.
  
  
  RESULTS
  Patient baseline characteristics were similar in the ciclesonide (n = 238) and placebo (n = 233) groups and were consistent with moderate PAR severity. Ciclesonide therapy significantly reduced average morning and evening reflective TNSSs compared with placebo (P < .001) and significantly reduced average morning and evening instantaneous TNSSs (P = .001) over 6 weeks of treatment. At the end point, a greater decrease from baseline was observed in physician-assessed overall nasal signs and symptoms severity for the ciclesonide group compared with the placebo group (P = .051). An appreciable improvement in combined Rhinoconjunctivitis Quality of Life Questionnaire scores at the end point was also observed in the ciclesonide group (P = .01 vs placebo). The frequency of adverse events was similar between treatment groups.
  
  
  CONCLUSIONS
  In this study, intranasal ciclesonide treatment was associated with significant reductions in nasal symptoms and appreciable improvements in health-related quality of life in adult and adolescent patients with PAR. Ciclesonide was well tolerated, with a safety profile comparable with that of placebo.
authors.affiliation: Allergy and Asthma Medical Group and Research Center, San Diego, California 92123-2661, USA. eomeltzer@aol.com
authors.forename: Eli O
authors.initials: EO
authors.lastname: Meltzer
authors.forename: Sudeesha
authors.initials: S
authors.lastname: Kunjibettu
authors.forename: Nancy
authors.initials: N
authors.lastname: Hall
authors.forename: Mark A
authors.initials: MA
authors.lastname: Wingertzahn
authors.forename: Crystal
authors.initials: C
authors.lastname: Murcia
authors.forename: William
authors.initials: W
authors.lastname: Berger
authors.forename: Craig
authors.initials: C
authors.lastname: LaForce
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011282:Pregnenediones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D018926:Anti-Allergic Agents; D011282:Pregnenediones; C120481:ciclesonide