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A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis.
J Allergy Clin Immunol 2012; 129(5):1282-1289.e10JA

Abstract

BACKGROUND

Moderate-to-severe allergic rhinitis (AR) is a challenge to treat, with many patients using multiple therapies and achieving limited symptom control. More effective therapies must be developed and tested in well-controlled, randomized, prospective studies with a direct comparison to current standards.

OBJECTIVES

The aim of these studies was to investigate the efficacy of MP29-02 (a novel formulation of azelastine and fluticasone propionate [FP]) in patients with moderate-to-severe seasonal allergic rhinitis (SAR) and to compare its efficacy with 2 first-line therapies (ie, intranasal azelastine and intranasal FP) in this population.

METHODS

Three thousand three hundred ninety-eight patients (≥12 years old) with moderate-to-severe SAR were enrolled into 3 multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group trials (MP4002 [NCT00651118], MP4004 [NCT00740792], and MP4006 [NCT00883168]). Each trial was conducted for 14 days during different allergy seasons. The primary efficacy variable was the sum of the morning and evening change from baseline in reflective total nasal symptom score (range, 0-24) over the treatment period. Outcomes for the meta-analysis included efficacy according to disease severity and time to response in relevant responder criteria.

RESULTS

In the meta-analysis MP29-02 reduced the mean reflective total nasal symptom score from baseline (-5.7 [SD, 5.3]) more than FP (-5.1 [SD, 4.9], P < .001), azelastine (-4.4 [SD, 4.8], P < .001), or placebo (-3.0 [SD, 4.2], P < .001). This benefit was observed from the first day of assessment, with improvement in each individual nasal symptom, even in the patients with the most severe disease. MP29-02 achieved response consistently days earlier and showed greater efficacy in patients with moderate-to-severe rhinitis than FP and azelastine.

CONCLUSIONS

MP29-02 represents a novel therapy that demonstrated superiority to 2 first-line therapies for AR. Patients with moderate-to-severe SAR achieved better control, and their symptoms were controlled earlier with MP29-02 than with recommended medications according to guidelines.

Authors+Show Affiliations

Allergy and Asthma Associates of Southern California, Mission Viejo, CA 92691, USA. wcarr@allergee.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

22418065

Citation

Carr, Warner, et al. "A Novel Intranasal Therapy of Azelastine With Fluticasone for the Treatment of Allergic Rhinitis." The Journal of Allergy and Clinical Immunology, vol. 129, no. 5, 2012, pp. 1282-1289.e10.
Carr W, Bernstein J, Lieberman P, et al. A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis. J Allergy Clin Immunol. 2012;129(5):1282-1289.e10.
Carr, W., Bernstein, J., Lieberman, P., Meltzer, E., Bachert, C., Price, D., ... Bousquet, J. (2012). A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis. The Journal of Allergy and Clinical Immunology, 129(5), pp. 1282-1289.e10. doi:10.1016/j.jaci.2012.01.077.
Carr W, et al. A Novel Intranasal Therapy of Azelastine With Fluticasone for the Treatment of Allergic Rhinitis. J Allergy Clin Immunol. 2012;129(5):1282-1289.e10. PubMed PMID: 22418065.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis. AU - Carr,Warner, AU - Bernstein,Jonathan, AU - Lieberman,Phil, AU - Meltzer,Eli, AU - Bachert,Claus, AU - Price,David, AU - Munzel,Ullrich, AU - Bousquet,Jean, Y1 - 2012/03/13/ PY - 2011/08/23/received PY - 2011/12/15/revised PY - 2012/01/19/accepted PY - 2012/3/16/entrez PY - 2012/3/16/pubmed PY - 2012/7/28/medline SP - 1282 EP - 1289.e10 JF - The Journal of allergy and clinical immunology JO - J. Allergy Clin. Immunol. VL - 129 IS - 5 N2 - BACKGROUND: Moderate-to-severe allergic rhinitis (AR) is a challenge to treat, with many patients using multiple therapies and achieving limited symptom control. More effective therapies must be developed and tested in well-controlled, randomized, prospective studies with a direct comparison to current standards. OBJECTIVES: The aim of these studies was to investigate the efficacy of MP29-02 (a novel formulation of azelastine and fluticasone propionate [FP]) in patients with moderate-to-severe seasonal allergic rhinitis (SAR) and to compare its efficacy with 2 first-line therapies (ie, intranasal azelastine and intranasal FP) in this population. METHODS: Three thousand three hundred ninety-eight patients (≥12 years old) with moderate-to-severe SAR were enrolled into 3 multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group trials (MP4002 [NCT00651118], MP4004 [NCT00740792], and MP4006 [NCT00883168]). Each trial was conducted for 14 days during different allergy seasons. The primary efficacy variable was the sum of the morning and evening change from baseline in reflective total nasal symptom score (range, 0-24) over the treatment period. Outcomes for the meta-analysis included efficacy according to disease severity and time to response in relevant responder criteria. RESULTS: In the meta-analysis MP29-02 reduced the mean reflective total nasal symptom score from baseline (-5.7 [SD, 5.3]) more than FP (-5.1 [SD, 4.9], P < .001), azelastine (-4.4 [SD, 4.8], P < .001), or placebo (-3.0 [SD, 4.2], P < .001). This benefit was observed from the first day of assessment, with improvement in each individual nasal symptom, even in the patients with the most severe disease. MP29-02 achieved response consistently days earlier and showed greater efficacy in patients with moderate-to-severe rhinitis than FP and azelastine. CONCLUSIONS: MP29-02 represents a novel therapy that demonstrated superiority to 2 first-line therapies for AR. Patients with moderate-to-severe SAR achieved better control, and their symptoms were controlled earlier with MP29-02 than with recommended medications according to guidelines. SN - 1097-6825 UR - https://www.unboundmedicine.com/medline/citation/22418065/A_novel_intranasal_therapy_of_azelastine_with_fluticasone_for_the_treatment_of_allergic_rhinitis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0091-6749(12)00272-2 DB - PRIME DP - Unbound Medicine ER -