A 26-week tolerability study of ciclesonide nasal aerosol in patients with perennial allergic rhinitis.
BACKGROUND
A new, hydrofluoroalkane nasal aerosol solution formulation of ciclesonide (CIC-HFA) delivered via a metered dose inhaler is currently in clinical development for treatment of allergic rhinitis.


OBJECTIVE
To study tolerability and quality  of life following administration of CIC-HFA 74- or 148-μg doses once-daily compared with placebo in patients with perennial allergic rhinitis (PAR) over 26 weeks.


METHODS
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 μg, 148 μg, or placebo QD AM for 26 weeks. Safety was assessed by monitoring treatment-emergent adverse events (TEAEs). Quality of life was assessed by using a rhinoconjunctivitis quality of life questionnaire with standardized  activities (RQLQ[S]) in patients with baseline RQLQ ≥3.00. Reflective total nasal symptom scores (rTNSS) and instantaneous total nasal symptom scores (iTNSS) over 26 weeks were also evaluated.


RESULTS
In this study, 1111 patients were randomized. The overall incidence  of TEAEs was comparable between the treatment groups. Treatment with CIC-HFA 74- or 148-μg doses showed improvements in RQLQ[S] [least squares (LS) mean change 0.40 and 0.37, respectively from baseline, p < 0.01 versus placebo for both], rTNSS (LS mean change 0.65 and 0.52, respectively  from baseline; p ≤ 0.01 versus placebo for both), and iTNSS (LS mean change 0.51 and 0.42, respectively from baseline; p < 0.05 versus placebo for both) from baseline.


CONCLUSIONS
In this study, once-daily treatment with CIC-HFA 74- or 148-μg doses over 26 weeks  was well tolerated with comparable incidence of TEAEs between the treatment groups.
Allergy and Asthma Associates, Mission Viejo, CA 92691, USA. weberger@uci.edu
William E
WE
Berger
Dale E
DE
Mohar
Craig
C
LaForce
Gordon
G
Raphael
Shailesh Y
SY
Desai
Holly
H
Huang
Joseph
J
Hinkle
D000328:Adult; D018926:Anti-Allergic Agents / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; 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* / Q000523:psychology
D018926:Anti-Allergic Agents; D059085:Nasal Sprays; D011282:Pregnenediones; C120481:ciclesonide