title: Efficacy and tolerability study of ciclesonide nasal aerosol in patients with perennial allergic rhinitis.
abstract: A new nasal aerosol solution formulation of ciclesonide containing a hydrofluoroalkane propellant (CIC-HFA) delivered via a metered-dose inhaler is currently in clinical development as a potential treatment for allergic rhinitis (AR). This study evaluated the efficacy and tolerability of CIC-HFA 74- or 148-microgram doses compared with placebo in patients with perennial AR (PAR). Patients ≥12 years of age with a ≥ 2-year history of PAR were randomized in a placebo-controlled, double-blind, parallel-group, multicenter study to CIC-HFA 74 micrograms, CIC-HFA 148 micrograms, or placebo q.d. in the morning (A.M.) for 26 weeks. Change from baseline in reflective total nasal symptom score (rTNSS), instantaneous total nasal symptom score (iTNSS), and rhinoconjunctivitis quality-of-life questionnaire with standardized activities (RQLQ[S]) in patients with baseline RQLQ of ≥3.00 were evaluated for the first 6 weeks of treatment. Treatment-emergent adverse events (TEAEs) were monitored throughout the study. Eleven hundred eleven patients were randomized. CIC-HFA 74- and 148-microgram doses showed statistically significant improvements in rTNSS (least squares [LS] mean change, 0.70 and 0.54, respectively; p ≤ 0.001 versus placebo for both), iTNSS (LS mean change, 0.58 and 0.42, respectively; p < 0.05 versus placebo for both), and RQLQ[S] (LS mean change, 0.55 and 0.37, respectively; p < 0.01 versus placebo for both) from baseline. The overall incidence of TEAEs was comparable between the CIC-HFA treatment groups and placebo. In this study, once-daily treatment with CIC-HFA 74- or 148-micrograms showed statistically significant improvements in nasal symptoms of PAR. Both doses were well tolerated. Clinical trial registration URL and registration number: www.clinicaltrials.gov/ct2/show/NCT00953147.
authors.affiliation: Kerrville Research Associates, Kerrville, Texas 78028, USA. dmohar@kerrresearch.com
authors.forename: Dale
authors.initials: D
authors.lastname: Mohar
authors.forename: William E
authors.initials: WE
authors.lastname: Berger
authors.forename: Craig
authors.initials: C
authors.lastname: Laforce
authors.forename: Gordon
authors.initials: G
authors.lastname: Raphael
authors.forename: Shailesh Y
authors.initials: SY
authors.lastname: Desai
authors.forename: Holly
authors.initials: H
authors.lastname: Huang
authors.forename: Joseph
authors.initials: J
authors.lastname: Hinkle
mesh_terms: D000328:Adult; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D059085:Nasal Sprays; D011282:Pregnenediones / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D018926:Anti-Allergic Agents; D059085:Nasal Sprays; D011282:Pregnenediones; C120481:ciclesonide