Abstract
A placebo-controlled randomized double-blind parallel-group comparison study of dexamethasone cipecilate (NS-126C) steroid nasal spray, conducted in those with perennial allergic rhinitis, clarified efficacy and safety of drug administration at 400 μg once a day for 12 weeks.
Of the 165 subjects in the Full Analysis Set (FAS) (NS-126C: 133; placebo: 32), total nasal symptom scores for sneezing, rhinorrhea, and nasal congestion in the NS-126C group improved significantly over the placebo group throughout the study with efficacy sustained for 12 weeks (p<0.001 to 0.024). Individual Scores for sneezing, rhinorrhea, and nasal congestion also improved more significantly in the NS-126C group over the placebo group throughout the study.
A total quality of life (QOL) study score based on the Japan Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ) was significantly higher in the NS-126C group than in the placebo group (p=0.001 to 0.017) throughout the study.
There was no significant difference in adverse event or drug reaction incidences between groups. Neither adverse events with an increase in incidence and no delayed adverse events due to long-term administration was seen. Plasma cortisol was unchanged over time, indicating the absence of an effect on adrenal cortical function. No abnormality was detected on the nasal mucociliary function test. Nasal discomfort, pharyngeal discomfort, and positive reaction to the nasal fungal test were observed in one patient per group as local adverse drug reactions.
Findings thus showed that NS-126C is a safe steroid nasal spray with long-acting efficacy improving QOL in patients with allergic rhinitis.
