Teva announced data from the Phase 3 clinical program for QNASL (beclomethasone dipropionate) Nasal Aerosol, highlighting the drug’s efficacy profile in treating children (ages 6–11) with nasal symptoms of seasonal allergic rhinitis (SAR). QNASL is a nonaqueous, “dry” nasal aerosol corticosteroid currently approved for the treatment of nasal symptoms associated with SAR and perennial allergic rhinitis (PAR) in patients aged ≥12 years.
In a two-week, randomized, double-blind, placebo-controlled study, 715 pediatric patients with SAR received once-daily treatment with QNASL 80mcg, 160mcg or placebo. The primary endpoint showed significantly greater (P<0.001) improvement in nasal symptoms compared with placebo for both QNASL 160mcg and 80mcg over the two-week treatment period. The data show greater (P<0.001) improvements from baseline in patient-reported AM and PM reflective total nasal symptom scores (rTNSS) and patient-reported AM and PM instantaneous total nasal symptom scores (iTNSS) with QNASL 160mcg and 80mcg as compared with placebo (P<0.01). Furthermore, physician-assessed nasal symptom scores (PNSS) show greater improvement in patients receiving QNASL160mcg and 80mcg vs. placebo (-.096, 95% CI: -1.4, -0.05, P<0.001 [80mcg]); (-.072, 95% CI: -1.2, -0.02, P=0.004 [160mcg]).
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