Azelastine hydrochloride nasal spray, 0.15%

The efficacy and safety of azelastine hydrochloride nasal spray, 0.15% with sweetener in seasonal allergic rhinitis was evaluated in five randomized, multicenter, double-blind, placebo-controlled clinical trials in 2499 adult and adolescent patients 12 years and older with symptoms of seasonal allergic rhinitis (Trials 2, 3, 4, 5, and 6). The population of the trials was 12 to 83 years of age (64% female, 36% male; 81% white, 12% black, <2% Asian, 5% other; 23% Hispanic, 77% non-Hispanic). Assessment of efficacy was based on the rTNSS, iTNSS as described above, and other supportive secondary efficacy variables. The primary efficacy endpoint was the mean change from baseline in rTNSS over 2 weeks.

Two 2-week seasonal allergic rhinitis trials evaluated the efficacy of azelastine hydrochloride nasal spray, 0.15% with sweetener dosed at 2 sprays twice daily. The first trial (Trial 2) compared the efficacy of azelastine hydrochloride nasal spray, 0.15% with sweetener and azelastine hydrochloride nasal spray without sweetener to vehicle placebo. The other trial (Trial 3) compared the efficacy of azelastine hydrochloride nasal spray, 0.15% with sweetener and azelastine hydrochloride nasal spray, 0.1% with sweetener to vehicle placebo. In these two trials, azelastine hydrochloride nasal spray, 0.15% with sweetener demonstrated greater decreases in rTNSS than placebo and the differences were statistically significant (Table 4).

Three 2-week seasonal allergic rhinitis trials evaluated the efficacy of azelastine hydrochloride nasal spray, 0.15% with sweetener dosed at 2 sprays once daily compared to the vehicle placebo. Trial 4 demonstrated a greater decrease in rTNSS than placebo and the difference was statistically significant (Table 4). Trial 5 and Trial 6 were conducted in patients with Texas mountain cedar allergy. In Trial 5 and Trial 6, azelastine hydrochloride nasal spray, 0.15% with sweetener demonstrated a greater decrease in rTNSS than placebo and the differences were statistically significant (Trials 5 and 6; Table 4). Instantaneous TNSS results for the once daily dosing regimen of azelastine hydrochloride nasal spray, 0.15% with sweetener are shown in Table 5. In Trials 5 and 6, azelastine hydrochloride nasal spray, 0.15% with sweetener demonstrated a greater decrease in iTNSS than placebo and the differences were statistically significant.

Azelastine hydrochloride nasal spray, 0.15% with sweetener at a dose of 1 spray twice daily was not studied. The azelastine hydrochloride nasal spray, 0.15% with sweetener 1 spray twice daily dosing regimen is supported by previous findings of efficacy for azelastine hydrochloride nasal spray without sweetener and a favorable comparison of azelastine hydrochloride nasal spray, 0.15% with sweetener to azelastine hydrochloride nasal spray, 0.1% without sweetener (Table 4).

The efficacy and safety of azelastine hydrochloride nasal spray, 0.15% in children 6 to 11 years of age with seasonal allergic rhinitis was evaluated in a clinical study that enrolled pediatric patients with perennial allergic rhinitis, with or without concomitant seasonal allergic rhinitis (described below in Section 14.2).