Evaluation of the efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol, 80 or 160 μg once daily, for the treatment of seasonal allergic rhinitis.
BACKGROUND
A hypotonic aqueous nasal spray of ciclesonide is indicated for the treatment of allergic rhinitis (AR). A new nasal aerosol formulation of ciclesonide containing a hydrofluoroalkane propellant delivered via a metered-dose inhaler (CIC-HFA) is currently in clinical development as a potential treatment for AR.


OBJECTIVE
To study the efficacy and safety of once-daily administration of CIC-HFA 80 or 160 μg compared with placebo in subjects 12 years and older with seasonal AR (SAR).


METHODS
Subjects 12 years and older with a ≥ 2-year history of SAR were randomized in a placebo-controlled, double-blind, parallel-group, multicenter study to receive CIC-HFA 80 or 160 μg or placebo once daily in the morning for 2 weeks. Changes from baseline in reflective total nasal symptom scores (rTNSSs), instantaneous TNSSs (iTNSSs), and reflective total ocular symptom scores (rTOSSs) in subjects with a baseline rTOSS of ≥ 5.00 were evaluated. Treatment-emergent adverse events were monitored throughout the study.


RESULTS
Seven hundred seven subjects were randomized. From baseline, CIC-HFA 80 or 160 μg demonstrated 15.1% and 16.0% reductions in rTNSSs (P < .0001, 3.7% for placebo), 14.3% and 15.4% reductions in iTNSSs (P < .0001, 3.9% for placebo), and 15.7% and 15.0% reductions in rTOSSs (P < .001, 6.8% for placebo). The overall incidence of treatment-emergent adverse events was low and comparable between the CIC-HFA and placebo groups.


CONCLUSIONS
In this study, once-daily treatment with CIC-HFA 80 or 160 μg demonstrated statistically significant improvements in nasal and ocular symptoms of SAR. Both doses of active treatment were well tolerated.
Sylvana Research Associates, San Antonio, Texas 78229, USA. pratner@sylvanaresearch.com
Paul
P
Ratner
Robert
R
Jacobs
Dale
D
Mohar
Holly
H
Huang
Shailesh Y
SY
Desai
Joseph
J
Hinkle
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000335:Aerosol Propellants / Q000008:administration & dosage*; D000368:Aged; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004339:Drug Compounding; D005260:Female; D006801:Humans; D006845:Hydrocarbons, Fluorinated / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D059085:Nasal Sprays; D011282:Pregnenediones / Q000008:administration & dosage* / Q000009:adverse effects; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D016896:Treatment Outcome; D014481:United States; D005466:Fluorocarbons
D000335:Aerosol Propellants; D018926:Anti-Allergic Agents; D006845:Hydrocarbons, Fluorinated; D059085:Nasal Sprays; D011282:Pregnenediones; C094049:apaflurane; D005466:Fluorocarbons; C120481:ciclesonide