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: Paul H Ratner, Charles Andrews, Bruce Martin, William Howland, Shailesh Y Desai, Holly Huang, Joseph Hinkle, Fred Bode
• Journal: Allergy and asthma proceedings (Allergy Asthma Proc) 2012 Jan-Feb Vol. 33 Issue 1 Pg. 27-35 ISSN: 1539-6304 [Electronic] United States
• PMID: 22370531 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Allergens
• Anti-Allergic Agents
• Antigens, Plant
• Hydrocarbons, Fluorinated
• Nasal Sprays
• Pregnenediones
• ciclesonide

Topics

• Adult
• Allergens (adverse effects, immunology)
• Anti-Allergic Agents (administration & dosage, adverse effects, chemistry)
• Antigens, Plant (immunology)
• Cedrus (immunology)
• Female
• Humans
• Hydrocarbons, Fluorinated (administration & dosage, chemistry)
• Male
• Middle Aged
• Nasal Sprays
• Pollen (adverse effects)
• Pregnenediones (administration & dosage, adverse effects, chemistry)
• Rhinitis, Allergic, Seasonal (drug therapy, physiopathology)
• Young Adult