Presentation: A Post-Hoc Analysis of Asthma Control and Lung Function Following Treatment with Ciclesonide 80 痢 HFA-MDI Twice Daily In Subjects with Mild-to-Moderate Persistent Asthma Previously Receiving Low Dose Fluticasone Propionate/Salmeterol (World Allergy Congress)

Tuesday, 6 December 2011: 12:45 - 13:00

Isla Mujeres (Canc𠒇 Center)

Eli Meltzer, MD , Allergy and Asthma Medical Group & Research Center, San Diego, CA

Bruce Prenner, MD , Allergy Associates Medical Group, Inc., San Diego, CA

Shailesh Desai, PhD , Sunovion Pharmaceuticals, Inc., Marlborough, MA

John Karafilidis, PharmD , Sunovion Pharmaceuticals, Inc., Marlborough, MA

John Walsh, MD , Sunovion Pharmaceuticals, Inc., Marlborough, MA

Background: Lung function and asthma symptom control changes following treatment with ciclesonide, an inhaled corticosteroid (ICS), in subjects with mild-to-moderate persistent asthma previously receiving low dose combination therapy of fluticasone propionate/salmeterol (FP/SAL) was evaluated.

Methods: This was a post-hoc analysis of data from a 12-week, multicenter, double-blind, placebo-controlled, parallel-group study (Meltzer et al, Allergy Asthma Proc, 2009). The sub-population included subjects ≥12 years of age with mild-to-moderate persistent asthma receiving treatment with low dose FP/SAL, ≤200μg/100μg daily via Diskus^® (43.5%) prior to study entry. Subjects received treatment with ciclesonide 80μg twice daily via HFA-MDI (CIC80BID, N=58) or placebo (N=61) for 12 weeks. Change in FEV₁from baseline to Week 12 and asthma control assessed by asthma symptom scores, nighttime awakenings(number/day) and rescue albuterol use(puffs/day) were evaluated.

Results: In subjects previously treated with low dose FP/SAL, FEV₁increased (LS mean change) from baseline to Week 12 following treatment with CIC80BID (N=58, 0.06L) versus a decrease with placebo (N=61, -0.12L, P=0.006 vs placebo). Non-clinically significant changes (LS mean change from baseline to Week 12) in nighttime awakenings (CIC80BID=0.01; placebo=0.15, P=0.0148 vs placebo), rescue albuterol use (CIC80BID=0.09; placebo=0.74, P=0.0108 vs placebo) were observed in CIC80BID and placebo group and change in total asthma symptom score (CIC80BID=-0.11; placebo=0.42, P=0.004 vs placebo) was observed in the placebo group.

Conclusions: In this post-hoc analysis, ciclesonide 80µg BID maintained lung function and asthma control in a sub-population of subjects with mild-to-moderate persistent asthma previously receiving treatment with low dose FP/SAL.

3192 A Post-Hoc Analysis of Asthma Control and Lung Function Following Treatment with Ciclesonide 80 痢 HFA-MDI Twice Daily In Subjects with Mild-to-Moderate Persistent Asthma Previously Receiving Low Dose Fluticasone Propionate/Salmeterol