ZETONNA® (ciclesonide) Nasal Aerosol significantly improved seasonal nasal and ocular symptoms, and year-round nasal symptoms
Statistically significant reductions in reflective Total Nasal Symptoms Score (rTNSS)1
Study Design:
A 2-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, clinical trial of seasonal allergic rhinitis (SAR) patients 12 years of age and older. Patients (n=707) were randomized to receive once-daily ZETONNA 74 mcg, placebo, or a higher dose. The primary endpoint of the study was the patient-reported LS mean change from baseline in average of AM and PM rTNSS over days 1 to 14. rTNSS was calculated as a sum of the 4 individual nasal symptoms: nasal congestion, nasal itching, sneezing, and runny nose.2
In addition, ZETONNA demonstrated statistically significant improvements in AM instantaneous Total Nasal Symptoms Score (iTNSS) from baseline vs placebo (-1.32 vs -0.46; P<.0001) for a full 24 hours1,4
Statistically significant reductions in reflective rTNSS1
Study Design:
A 6-month, randomized, double-blind, placebo-controlled, parallel-group, multicenter, clinical trial of patients 12 years of age and older with perennial allergic rhinitis (PAR). Patients (n=1110) were randomized to receive once-daily ZETONNA 74 mcg, placebo, or a higher dose. The primary endpoint of the study was the patient-evaluated change from baseline in average of AM and PM rTNSS over days 1 to 42.3
In addition, ZETONNA demonstrated statistically significant improvements in iTNSS from baseline (days 1-42) vs placebo (-1.8 vs -1.2; P<0.001) for patients with PAR1,5
Statistically significant reductions in reflective Total Ocular Symptom Score (rTOSS)*1
Study Design:
A 2-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, clinical trial of SAR patients 12 years of age and older. Patients (n=707) were randomized to receive once-daily ZETONNA 74 mcg, placebo or a higher dose. The primary endpoint of the study was the patient-reported LS mean change from baseline in average of AM and PM rTNSS over days 1 to 14. rTOSS was calculated as a sum of 3 individual ocular symptoms: redness of eyes, itching eyes, and tearing eyes.2
*Data shown are for the secondary endpoint, reductions in the overall symptom score, as measured by average of AM and PM rTOSS (LS mean change from baseline over days 1-14) in intent-to-treat population.1
