A Post-Hoc Responder Analysis of Improvement in Symptoms Following Treatment with Ciclesonide Hydrofluoroalkane Nasal Aerosol in Patients with Seasonal and Perennial Allergic Rhinitis

RationaleA hydrofluoroalkane nasal aerosol solution formulation of ciclesonide (CIC-HFA) has been approved for the treatment of allergic rhinitis. This post-hoc, responder analysis evaluated improvement in nasal and ocular symptoms in patients with seasonal allergic rhinitis (SAR) and nasal symptoms in patients with perennial allergic rhinitis (PAR) following treatment with CIC-HFA.MethodsData for this post-hoc, responder analysis was collected from randomized, double-blind, placebo-controlled SAR (pooled from 2 studies) and PAR (N=1) studies. Patients 12-65 years of age with SAR (N=918) or PAR (N=605) received CIC-HFA 74μg (1 actuation/nostril, 37 μg/actuation) or placebo for 2 weeks (SAR) or 26 weeks (PAR) respectively. Change from baseline (percent of patients with ≥20%, ≥30%, and ≥50% improvement) in reflective nasal (rTNSS) and ocular (rTOSS, SAR only) symptom scores were evaluated.ResultsA higher percentage of SAR patients reported ≥20% (40.8% vs 21%), ≥30% (30.2% vs11.9%), and ≥50% (11.2% vs 3.8%) improvement in rTNSS with CIC-HFA 74μg compared with placebo (P<0.0001 for all) and ≥20% (39.3% vs 26.7%), ≥30% (27.9% vs 14.8%), and ≥50% (12.7% vs 5.5%) improvement in rTOSS with CIC-HFA 74μg compared with placebo (P≤0.0016 for all) from baseline. A higher percentage of PAR patients at 26 weeks also reported ≥20% (61.6% vs 52.6%), ≥30% (50.2% vs 37.2%), and ≥50% (25.9% vs 13.5%) improvement in rTNSS with CIC-HFA 74μg compared with placebo (P<0.05 for all) from baseline.ConclusionsIn this post-hoc, responder analysis of 3 studies, treatment with CIC-HFA 74μg showed significant improvement in nasal and ocular symptoms of SAR and nasal symptoms of PAR. RationaleA hydrofluoroalkane nasal aerosol solution formulation of ciclesonide (CIC-HFA) has been approved for the treatment of allergic rhinitis. This post-hoc, responder analysis evaluated improvement in nasal and ocular symptoms in patients with seasonal allergic rhinitis (SAR) and nasal symptoms in patients with perennial allergic rhinitis (PAR) following treatment with CIC-HFA. A hydrofluoroalkane nasal aerosol solution formulation of ciclesonide (CIC-HFA) has been approved for the treatment of allergic rhinitis. This post-hoc, responder analysis evaluated improvement in nasal and ocular symptoms in patients with seasonal allergic rhinitis (SAR) and nasal symptoms in patients with perennial allergic rhinitis (PAR) following treatment with CIC-HFA. MethodsData for this post-hoc, responder analysis was collected from randomized, double-blind, placebo-controlled SAR (pooled from 2 studies) and PAR (N=1) studies. Patients 12-65 years of age with SAR (N=918) or PAR (N=605) received CIC-HFA 74μg (1 actuation/nostril, 37 μg/actuation) or placebo for 2 weeks (SAR) or 26 weeks (PAR) respectively. Change from baseline (percent of patients with ≥20%, ≥30%, and ≥50% improvement) in reflective nasal (rTNSS) and ocular (rTOSS, SAR only) symptom scores were evaluated. Data for this post-hoc, responder analysis was collected from randomized, double-blind, placebo-controlled SAR (pooled from 2 studies) and PAR (N=1) studies. Patients 12-65 years of age with SAR (N=918) or PAR (N=605) received CIC-HFA 74μg (1 actuation/nostril, 37 μg/actuation) or placebo for 2 weeks (SAR) or 26 weeks (PAR) respectively. Change from baseline (percent of patients with ≥20%, ≥30%, and ≥50% improvement) in reflective nasal (rTNSS) and ocular (rTOSS, SAR only) symptom scores were evaluated. ResultsA higher percentage of SAR patients reported ≥20% (40.8% vs 21%), ≥30% (30.2% vs11.9%), and ≥50% (11.2% vs 3.8%) improvement in rTNSS with CIC-HFA 74μg compared with placebo (P<0.0001 for all) and ≥20% (39.3% vs 26.7%), ≥30% (27.9% vs 14.8%), and ≥50% (12.7% vs 5.5%) improvement in rTOSS with CIC-HFA 74μg compared with placebo (P≤0.0016 for all) from baseline. A higher percentage of PAR patients at 26 weeks also reported ≥20% (61.6% vs 52.6%), ≥30% (50.2% vs 37.2%), and ≥50% (25.9% vs 13.5%) improvement in rTNSS with CIC-HFA 74μg compared with placebo (P<0.05 for all) from baseline. A higher percentage of SAR patients reported ≥20% (40.8% vs 21%), ≥30% (30.2% vs11.9%), and ≥50% (11.2% vs 3.8%) improvement in rTNSS with CIC-HFA 74μg compared with placebo (P<0.0001 for all) and ≥20% (39.3% vs 26.7%), ≥30% (27.9% vs 14.8%), and ≥50% (12.7% vs 5.5%) improvement in rTOSS with CIC-HFA 74μg compared with placebo (P≤0.0016 for all) from baseline. A higher percentage of PAR patients at 26 weeks also reported ≥20% (61.6% vs 52.6%), ≥30% (50.2% vs 37.2%), and ≥50% (25.9% vs 13.5%) improvement in rTNSS with CIC-HFA 74μg compared with placebo (P<0.05 for all) from baseline. ConclusionsIn this post-hoc, responder analysis of 3 studies, treatment with CIC-HFA 74μg showed significant improvement in nasal and ocular symptoms of SAR and nasal symptoms of PAR. In this post-hoc, responder analysis of 3 studies, treatment with CIC-HFA 74μg showed significant improvement in nasal and ocular symptoms of SAR and nasal symptoms of PAR.