title: A study of the efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol in patients with seasonal allergic rhinitis from mountain cedar pollen.
abstract: A nasal aerosol formulation of ciclesonide with a hydrofluoroalkane propellant (CIC-HFA) is currently in development for treatment of allergic rhinitis (AR). This study evaluated the efficacy and safety of once-daily administration of CIC-HFA 74 or 148 micrograms compared with placebo  in patients with seasonal AR (SAR) from mountain cedar pollen. Patients ≥12 years of age with a ≥2-year history of SAR from mountain cedar pollen were randomized in a placebo-controlled, double-blind, parallel group, multicenter study to CIC-HFA 74 micrograms, CIC-HFA 148 micrograms,  or placebo once daily in the morning for 2 weeks. Change from baseline in reflective total nasal symptom score (rTNSS), instantaneous TNSS (iTNSS), and reflective total ocular symptom score (rTOSS) in patients with baseline rTOSS ≥5.00 were evaluated. Adverse events (AEs) were monitored  throughout the study. A statistically significant improvement in rTNSS (least squares [LS] mean change from baseline 1.04 and 1.02 respectively; p < 0.0001 versus placebo for both) and iTNSS (LS mean change from baseline 0.90 and 0.83 respectively; p < 0.001 vs placebo for both) was  observed after treatment with CIC-HFA 74- or 148-microgram doses. Only the CIC-HFA 74-micrograms treatment group showed a statistically significant improvement in rTOSS (LS mean change from baseline 0.52; p = 0.0124) compared with placebo. The overall incidence of AEs was low and comparable  between the treatment groups. In this study, statistically significant improvements in nasal symptoms of SAR were observed after treatment with CIC-HFA 74-microgram or CIC-HFA 148-microgram doses. Both active treatments were well tolerated. Clinical trial registry URL and registration number:  www.clinicaltrials.gov/ct2/show/NCT01010971.
authors.affiliation: Sylvana Research Associates, San Antonio, Texas 78229, USA. dmohar@kerrresearch.com
authors.forename: Paul H
authors.initials: PH
authors.lastname: Ratner
authors.forename: Charles
authors.initials: C
authors.lastname: Andrews
authors.forename: Bruce
authors.initials: B
authors.lastname: Martin
authors.forename: William
authors.initials: W
authors.lastname: Howland
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
authors.forename: Fred
authors.initials: F
authors.lastname: Bode
mesh_terms: D000328:Adult; D000485:Allergens / Q000009:adverse effects / Q000276:immunology; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D052179:Antigens, Plant / Q000276:immunology; D028203:Cedrus / Q000276:immunology; D005260:Female; D006801:Humans; D006845:Hydrocarbons, Fluorinated / Q000008:administration & dosage / Q000737:chemistry; D008297:Male; D008875:Middle Aged; D059085:Nasal Sprays; D011058:Pollen / Q000009:adverse effects; D011282:Pregnenediones / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000503:physiopathology; D055815:Young Adult
chemical_list: D000485:Allergens; D018926:Anti-Allergic Agents; D052179:Antigens, Plant; D006845:Hydrocarbons, Fluorinated; D059085:Nasal Sprays; D011282:Pregnenediones; C120481:ciclesonide