Phase 3 Study of QNASL for Seasonal and Perennial Allergic Rhinitis

Teva announced findings from four Phase 3 clinical studies that examined the efficacy and safety profile as well as impact on quality of life (QoL) of QNASL (beclomethasone dipropionate [BDP]) Nasal Aerosol, a non-aqueous, “dry” nasal aerosol corticosteroid in development for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR).

In a 52-week, double-blind, placebo-controlled, parallel-group study, 529 patients with PAR, aged ≥12 years, were randomized to receive once-daily treatment with QNASL 320mcg or placebo. The primary endpoint showed a significant (P<0.001) change from baseline weekly averages of the subject reported 24-hour reflective nasal symptom scores (rTNSS) over the first 30 weeks of the treatment period. An additional 52 weeks of QNASL treatment showed significantly greater improvements from baseline over a 24-hour period in both rTNSS (-1.09 [95% CI: -1.6, -0.6], P<0.001) and instantaneous nasal symptom scores (iTNSS) (-1.10 [95% CI: -1.6, -0.6]; P<0.001) compared with placebo.

Results from a 6-week, double-blind, placebo-controlled, parallel-group study of patients with PAR (N=474) demonstrated that QNASL significantly improved quality of life compared with placebo (-0.58 [95% CI: -0.9, -0.2]; P=0.001), as assessed by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Improvements from baseline were greater with QNASL for all seven individual domains of the RQLQ. Physician-reported nasal symptom scores were also significantly improved (-1.22 [95% CI: -1.7, -0.7]; P<0.001). The primary endpoint of change from baseline of average AM and PM subject-reported rTNSS was also significant (P<0.001).

Finally, a 2-week, randomized, double-blind, placebo-controlled study in 715 children (6–11 years of age) with SAR demonstrated that improvements in both AM and PM rTNSS were significantly greater for those treated with QNASL 80mcg (-0.71 [95% CI: -1.1, -0.3) and 160mcg (-0.76 [95% CI: -1.1, -0.4) compared with placebo.

QNASL is an intranasal corticosteroid administered as a non-aqueous or "dry” spray delivered by hydrofluoroalkane (HFA).

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