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-mu g 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 mu g, 148 mu g, 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-mu g 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-mu g doses over 26 weeks was well tolerated with comparable incidence of TEAEs between the treatment groups. (Am J Rhinol Allergy 26, 302-307, 2012; doi: 10.2500/ajra.2012.26.3773)