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- Open Access
A new therapy (MP29-02*) effectively treats patients with seasonal allergic rhinitis who suffer most from the bothersome nasal symptom of congestion
© Bachert et al; licensee BioMed Central Ltd. 2013
- Published: 16 July 2013
- Allergic Rhinitis
- Allergic Rhinitis
- Fluticasone Propionate
- Nasal Congestion
In clinical practice, allergic rhinitis (AR) patients frequently present with a predominant or particularly bothersome symptom, most frequently nasal congestion.
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.
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 (all given as 1 spray/nostril bid; total daily dose: 548µg AZE, 200µg FP]. Patients were defined as 'nasal congestion predominants' if their maximum symptom score at baseline was the nasal congestion score (n=368). Both reflective total nasal symptom score (rTNSS; max score =24) and nasal congestion symptom score (max score =6) reduction were assessed in these patients to show effect on their overall nasal symptom burden, as well as specific relief from nasal congestion.
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 placebo (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. 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 placebo (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. Neither AZE nor FP significantly differed from placebo in terms of nasal congestion reduction in these patients.
Unlike currently available first line therapy, MP29-02* effectively reduced nasal congestion and the overall nasal symptom burden of patients suffering predominantly from nasal congestion. This indicates that for nasal congestion predominant patients a decongestant might not be required prior to MP29-02* administration, and further supports the position of MP29-02*as the drug of choice for the treatment of AR.
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.