OLOPATADINE |
MOMETASONE |
|||
FAST-ACTING ANTIHISTAMINE |
+ |
ESTABLISHED CORTICOSTEROID |
= |
RYALTRIS® |
Study Design1
The efficacy of RYALTRIS® was evaluated in 2 multicenter, randomized, double-blind, placebo- and active-controlled clinical studies of 2 weeks’ duration (Study 1 and Study 2). The 2 studies were of similar design, including a single-blind, placebo run-in period for 7 to 10 days, and enrolled a total of 2352 patients 12 years of age and older with seasonal allergic rhinitis. Patients had a history of seasonal allergic rhinitis for at least 2 years prior to screening, a positive skin prick test (wheal diameter 5 mm, or greater than negative diluent control) to relevant seasonal allergens (tree/grass pollen in Study 1 and ragweed/mountain cedar pollen in Study 2), and nasal symptoms defined as a 12-hour reflective total nasal symptom score (rTNSS) ≥8 out of 12 and a congestion score ≥2 for the morning (AM) assessment at screening.
In Studies 1 and 2, patients were randomized to 1 of 4 treatment groups: RYALTRIS® 2 sprays (665 mcg olopatadine hydrochloride and 25 mcg mometasone furoate per spray) per nostril twice daily; olopatadine hydrochloride nasal spray 2 sprays (665 mcg per spray) per nostril twice daily; mometasone furoate nasal spray 2 sprays (25 mcg per spray) per nostril twice daily; or vehicle placebo for 2 weeks. The olopatadine hydrochloride and mometasone furoate comparators used the same device and vehicle as RYALTRIS® but were non–US-approved drugs.
The primary endpoint for both studies was the change from baseline in average morning (AM) and evening (PM) patient-reported 12-hour rTNSS over the 14-day treatment period. Total nasal symptom score was calculated as the sum of the patient-reported symptom scores of 4 individual nasal symptoms (rhinorrhea, nasal congestion, sneezing, and nasal itching) on a 0 to 3 categorical severity scale (0=absent, 1=mild, 2=moderate, and 3=severe).
Secondary endpoints included change from baseline in average AM and PM subject-reported 12-hour instantaneous total nasal symptom score (iTNSS) over the 14-day treatment period and change from baseline in average AM and PM subject-reported 12-hour reflective total ocular symptom score (rTOSS) over the 14-day treatment period. Similarly, rTOSS and iTOSS were calculated as the sum of patient’s scoring of 3 individual ocular symptoms (itching/burning, tearing/watering, and redness) on a 0 to 3 categorical severity scale (0=absent, 1=mild, 2=moderate, and 3=severe).
Patients were required to record symptom severity daily (morning [AM] and evening [PM]), reflecting over the previous 12 hours (reflective) or at the time of dosing (instantaneous). The primary efficacy endpoint was the mean change from baseline in average AM and PM patient-reported 12-hour rTNSS over the 2-week treatment period. The average AM and PM rTNSS (maximum score of 12) was assessed as the change from baseline for each day and then averaged over a 2-week treatment period.
Reference