Abstract
• In the ITT population and over the entire 14-day treatment period, MP29-02* most effectively relieved patients’ overall nasal symptoms, reducing the rTNSS from baseline by -5.31 compared to -3.84 for FP (Diff: -1.47; 95% CI: -2.44, -0.50; p=0.0031), -3.25 for AZE (Diff -2.06; 95% CI: -2.98, -1.14; p<0.0001) and -2.20 for PLA (Diff -3.11; 95% CI: -4.03, -2.19; p<0.0001). The relative difference was 47% to FP and 66% to AZE (Figure 2). • MP29-02* relieved patients’ nasal symptoms rapidly, from the first day of assessment to Day 14, with treatment difference and significance maintained at Day 14 vs AZE and FP. • MP29-02* induced the greatest reduction in rTNSS in patients complaining of nasal congestion (-5.64), compared to -3.93 for FP (Diff -1.71; 95% CI -3.00, -0.43; p=0.0093), -3.28 for AZE (Diff -2.36; 95% CI -3.51, -1.21; p<0.0001) and -2.63 for PLA (Diff -3.01; 95% CI -4.14, -1.88; p<0.0001), corresponding to a relative treatment difference of 57% to FP and 79% to AZE (Figure 3). • These nasal congestion-predominant patients treated with MP29-02* also experienced a significantly greater reduction in their nasal congestion score; -1.41 vs -0.90 for FP (Diff: -0.51; 95% CI -0.83, -0.19; p=0.0018), -0.83 for AZE (Diff: -0.58; 95% CI -0.88, -0.29; p=0.0001) and -0.69 for PLA (Diff -0.72; 95% CI -1.02, -0.42; p<0.0001), with a relative treatment difference of 71% to FP and 81% to AZE (Figure 3). • Neither AZE nor FP significantly differed from PLA in terms of nasal congestion reduction in these patients.
Highlights
In clinical practice, allergic rhinitis (AR) patients frequently present with a predominant or bothersome symptom, most frequently nasal congestion
To assess the efficacy of MP29-02* in patients with seasonal AR (SAR) suffering predominantly from nasal congestion, compared to commercially available AZE or FP nasal sprays and placebo
610 patients (≥12 years old) with moderate-to-severe SAR were randomized into a double-blind, placebo-controlled, 14-day, parallel-group trial to MP29-02*, AZE or FP nasal sprays and placebo
Summary
To assess the efficacy of MP29-02* (a novel intranasal formulation of azelastine hydrochloride [AZE] and fluticasone propionate [FP]) in patients with seasonal AR (SAR) suffering predominantly from nasal congestion, compared to commercially available AZE or FP nasal sprays and placebo
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