A 26-week tolerability study of ciclesonide nasal aerosol in patients with perennial allergic rhinitis.

ABSTRACT

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. CONCLUSION: 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.