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MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) in the treatment of seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial of efficacy and safety.
Allergy Asthma Proc. 2012 Jul-Aug; 33(4):324-32.AA

Abstract

Many patients with allergic rhinitis (AR) have uncontrolled symptoms despite available treatment options. This study was designed to evaluate the efficacy and safety of MP29-02 (a novel intranasal formulation of fluticasone propionate [FP] and azelastine [AZ] hydrochloride), compared with monotherapy with FP, AZ, and placebo sprays for the treatment of seasonal allergic rhinitis (SAR). This 2-week randomized, double-blind, placebo-controlled trial was conducted in 779 patients with moderate-to-severe SAR. Treatments were administered 1 spray/nostril twice daily in the same vehicle and delivery device. Daily doses of AZ and FP were 548 and 200 micrograms, respectively. The primary efficacy variable was the 12-hour reflective total nasal symptom score (rTNSS), consisting of nasal congestion, sneezing, itchy nose, and runny nose. Secondary efficacy variables were (1) 12-hour reflective individual nasal symptom scores; (2) onset of action; (3) 12-hour reflective total ocular symptom score (rTOSS), including itchy eyes, watery eyes, and red eyes; and (4) the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) overall score. MP29-02 significantly reduced the mean rTNSS from baseline by -5.54 points compared with FP (-4.55; p = 0.038), AZ (-4.54; p = 0.032), and placebo (-3.03; p < 0.001), improving the rTNSS by 39% beyond the contribution of FP. All individual nasal symptoms contributed to the efficacy of MP29-02. Onset of action was within 30 minutes. MP29-02 significantly improved rTOSS compared with placebo, provided a clinically important improvement in the overall RQLQ score, and was well tolerated. In this study, MP29-02 provided more complete symptom relief than two widely used first-line AR treatments and was well tolerated.

Authors+Show Affiliations

Allergy and Asthma Medical Group and Research Center, San Diego, California 92123, USA. EOMELTZER@aol.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

22856633

Citation

Meltzer, Eli O., et al. "MP29-02 (a Novel Intranasal Formulation of Azelastine Hydrochloride and Fluticasone Propionate) in the Treatment of Seasonal Allergic Rhinitis: a Randomized, Double-blind, Placebo-controlled Trial of Efficacy and Safety." Allergy and Asthma Proceedings, vol. 33, no. 4, 2012, pp. 324-32.
Meltzer EO, LaForce C, Ratner P, et al. MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) in the treatment of seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial of efficacy and safety. Allergy Asthma Proc. 2012;33(4):324-32.
Meltzer, E. O., LaForce, C., Ratner, P., Price, D., Ginsberg, D., & Carr, W. (2012). MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) in the treatment of seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial of efficacy and safety. Allergy and Asthma Proceedings, 33(4), 324-32. https://doi.org/10.2500/aap.2012.33.3587
Meltzer EO, et al. MP29-02 (a Novel Intranasal Formulation of Azelastine Hydrochloride and Fluticasone Propionate) in the Treatment of Seasonal Allergic Rhinitis: a Randomized, Double-blind, Placebo-controlled Trial of Efficacy and Safety. Allergy Asthma Proc. 2012 Jul-Aug;33(4):324-32. PubMed PMID: 22856633.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) in the treatment of seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial of efficacy and safety. AU - Meltzer,Eli O, AU - LaForce,Craig, AU - Ratner,Paul, AU - Price,David, AU - Ginsberg,David, AU - Carr,Warner, PY - 2012/8/4/entrez PY - 2012/8/4/pubmed PY - 2012/12/21/medline SP - 324 EP - 32 JF - Allergy and asthma proceedings JO - Allergy Asthma Proc VL - 33 IS - 4 N2 - Many patients with allergic rhinitis (AR) have uncontrolled symptoms despite available treatment options. This study was designed to evaluate the efficacy and safety of MP29-02 (a novel intranasal formulation of fluticasone propionate [FP] and azelastine [AZ] hydrochloride), compared with monotherapy with FP, AZ, and placebo sprays for the treatment of seasonal allergic rhinitis (SAR). This 2-week randomized, double-blind, placebo-controlled trial was conducted in 779 patients with moderate-to-severe SAR. Treatments were administered 1 spray/nostril twice daily in the same vehicle and delivery device. Daily doses of AZ and FP were 548 and 200 micrograms, respectively. The primary efficacy variable was the 12-hour reflective total nasal symptom score (rTNSS), consisting of nasal congestion, sneezing, itchy nose, and runny nose. Secondary efficacy variables were (1) 12-hour reflective individual nasal symptom scores; (2) onset of action; (3) 12-hour reflective total ocular symptom score (rTOSS), including itchy eyes, watery eyes, and red eyes; and (4) the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) overall score. MP29-02 significantly reduced the mean rTNSS from baseline by -5.54 points compared with FP (-4.55; p = 0.038), AZ (-4.54; p = 0.032), and placebo (-3.03; p < 0.001), improving the rTNSS by 39% beyond the contribution of FP. All individual nasal symptoms contributed to the efficacy of MP29-02. Onset of action was within 30 minutes. MP29-02 significantly improved rTOSS compared with placebo, provided a clinically important improvement in the overall RQLQ score, and was well tolerated. In this study, MP29-02 provided more complete symptom relief than two widely used first-line AR treatments and was well tolerated. SN - 1539-6304 UR - https://www.unboundmedicine.com/medline/citation/22856633/MP29_02__a_novel_intranasal_formulation_of_azelastine_hydrochloride_and_fluticasone_propionate__in_the_treatment_of_seasonal_allergic_rhinitis:_a_randomized_double_blind_placebo_controlled_trial_of_efficacy_and_safety_ L2 - https://www.ingentaconnect.com/openurl?genre=article&amp;issn=1088-5412&amp;volume=33&amp;issue=4&amp;spage=324&amp;aulast=Meltzer DB - PRIME DP - Unbound Medicine ER -