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Efficacy of a Novel Intranasal Formulation of Azelastine Hydrochloride and Fluticasone Propionate, Delivered in a Single Spray, for the Treatment of Seasonal Allergic Rhinitis: Results from Russia.
Int Arch Allergy Immunol 2019; 178(3):255-263IA

Abstract

BACKGROUND

The novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP) in a single spray (MP-AzeFlu) was compared with a first-line intranasal antihistamine spray (AZE) in Russian seasonal allergic rhinitis (SAR) patients.

METHODS

Moderate-to-severe SAR/rhinoconjunctivitis patients (n = 149; aged 18-65 years) were randomized to receive MP-AzeFlu (137/50 μg AZE/FP per spray) or AZE (137 μg/spray), both as 1 spray/nostril twice daily, in a multicenter, open-label, 14-day, parallel-group trial. The primary outcome was change from baseline in morning and evening reflective total nasal symptom score (rTNSS). Secondary end points included: change from baseline in reflective total ocular symptom score (rTOSS), reflective total of 7 symptom scores (rT7SS), 28-item Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) overall score, and EuroQol-5D (EQ-5D) questionnaire score.

RESULTS

When compared with AZE-treated patients, those treated with MP-AzeFlu experienced significantly greater reductions in rTNSS (difference: -2.47; 95% confidence interval [CI] -3.65 to -1.30; p < 0.001), rTOSS (difference: -1.62; 95% CI -2.32 to -0.92; p < 0.001), and rT7SS (difference: -4.34; 95% CI -5.98 to -2.70; p < 0.001). Superior relief observed on day 2 with MP-AzeFlu versus AZE was sustained throughout the study. MP-AzeFlu-treated patients experienced a greater improvement in QoL than AZE-treated patients as measured by overall RQLQ score (mean ± SD 2.91 ± 1.08 vs. 2.05 ± 1.15) and EQ-5D score (mean ± SD 87.4 ± 10.3 vs. 83.0 ± 12.8). MP-AzeFlu was well tolerated.

CONCLUSIONS

MP-AzeFlu was superior to AZE in reducing moderate-to-severe SAR symptoms, providing earlier and more complete symptom relief.

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  • Publisher Full Text

    • Authors+Show Affiliations

    Ilyina NI
    Federal State Budget Institution, State Scientific Center Institute of Immunology of the Federal Biomedical Agency, Moscow, Russian Federation, instimmun@yandex.ru.
    Edin AS
    LLC Alliance Biomedical Russian Group, Saint Petersburg, Russian Federation.
    Astafieva NG
    State Budget Educational Institution of Higher Professional Education, Saratov State Medical University named after V.I. Razumovsky of the Ministry of Healthcare of the Russian Federation, Saratov, Russian Federation.
    Lopatin AS
    Federal State Institution Polyclinic N1 of the Administration of the President of the Russian Federation, Moscow, Russian Federation.
    Sidorenko IV
    State Budget Institution of Higher Professional Education, The First Moscow Medical University named after I.M. Sechenov of the Ministry of Healthcare, Moscow, Russian Federation.
    Ukhanova OP
    State Budgeted Institution of Healthcare, Stavropol Regional Clinical Hospital, Stavropol, Russian Federation.
    Khanova FM
    Research Center of Otorhinolaryngology of the Federal Biomedical Agency, Moscow, Russian Federation.

    MeSH

    Administration, IntranasalAdultDrug CompoundingFemaleFluticasoneHumansMaleMiddle AgedPhthalazinesQuality of LifeRhinitis, Allergic, Seasonal

    Pub Type(s)

    Clinical Trial, Phase III
    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    30677766

    Citation

    Ilyina, Natalia I., et al. "Efficacy of a Novel Intranasal Formulation of Azelastine Hydrochloride and Fluticasone Propionate, Delivered in a Single Spray, for the Treatment of Seasonal Allergic Rhinitis: Results From Russia." International Archives of Allergy and Immunology, vol. 178, no. 3, 2019, pp. 255-263.
    Ilyina NI, Edin AS, Astafieva NG, et al. Efficacy of a Novel Intranasal Formulation of Azelastine Hydrochloride and Fluticasone Propionate, Delivered in a Single Spray, for the Treatment of Seasonal Allergic Rhinitis: Results from Russia. Int Arch Allergy Immunol. 2019;178(3):255-263.
    Ilyina, N. I., Edin, A. S., Astafieva, N. G., Lopatin, A. S., Sidorenko, I. V., Ukhanova, O. P., & Khanova, F. M. (2019). Efficacy of a Novel Intranasal Formulation of Azelastine Hydrochloride and Fluticasone Propionate, Delivered in a Single Spray, for the Treatment of Seasonal Allergic Rhinitis: Results from Russia. International Archives of Allergy and Immunology, 178(3), pp. 255-263. doi:10.1159/000494507.
    Ilyina NI, et al. Efficacy of a Novel Intranasal Formulation of Azelastine Hydrochloride and Fluticasone Propionate, Delivered in a Single Spray, for the Treatment of Seasonal Allergic Rhinitis: Results From Russia. Int Arch Allergy Immunol. 2019;178(3):255-263. PubMed PMID: 30677766.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy of a Novel Intranasal Formulation of Azelastine Hydrochloride and Fluticasone Propionate, Delivered in a Single Spray, for the Treatment of Seasonal Allergic Rhinitis: Results from Russia. AU - Ilyina,Natalia I, AU - Edin,Anton S, AU - Astafieva,Natalia G, AU - Lopatin,Andrey S, AU - Sidorenko,Irina V, AU - Ukhanova,Olga P, AU - Khanova,Fatimat M, Y1 - 2019/01/24/ PY - 2018/05/04/received PY - 2018/10/12/accepted PY - 2019/1/25/pubmed PY - 2019/6/1/medline PY - 2019/1/25/entrez KW - Allergic rhinitis KW - Azelastine KW - Fluticasone propionate KW - Intranasal KW - MP-AzeFlu KW - Moderate-to-severe rhinitis KW - Russia KW - Seasonal SP - 255 EP - 263 JF - International archives of allergy and immunology JO - Int. Arch. Allergy Immunol. VL - 178 IS - 3 N2 - BACKGROUND: The novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP) in a single spray (MP-AzeFlu) was compared with a first-line intranasal antihistamine spray (AZE) in Russian seasonal allergic rhinitis (SAR) patients. METHODS: Moderate-to-severe SAR/rhinoconjunctivitis patients (n = 149; aged 18-65 years) were randomized to receive MP-AzeFlu (137/50 μg AZE/FP per spray) or AZE (137 μg/spray), both as 1 spray/nostril twice daily, in a multicenter, open-label, 14-day, parallel-group trial. The primary outcome was change from baseline in morning and evening reflective total nasal symptom score (rTNSS). Secondary end points included: change from baseline in reflective total ocular symptom score (rTOSS), reflective total of 7 symptom scores (rT7SS), 28-item Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) overall score, and EuroQol-5D (EQ-5D) questionnaire score. RESULTS: When compared with AZE-treated patients, those treated with MP-AzeFlu experienced significantly greater reductions in rTNSS (difference: -2.47; 95% confidence interval [CI] -3.65 to -1.30; p < 0.001), rTOSS (difference: -1.62; 95% CI -2.32 to -0.92; p < 0.001), and rT7SS (difference: -4.34; 95% CI -5.98 to -2.70; p < 0.001). Superior relief observed on day 2 with MP-AzeFlu versus AZE was sustained throughout the study. MP-AzeFlu-treated patients experienced a greater improvement in QoL than AZE-treated patients as measured by overall RQLQ score (mean ± SD 2.91 ± 1.08 vs. 2.05 ± 1.15) and EQ-5D score (mean ± SD 87.4 ± 10.3 vs. 83.0 ± 12.8). MP-AzeFlu was well tolerated. CONCLUSIONS: MP-AzeFlu was superior to AZE in reducing moderate-to-severe SAR symptoms, providing earlier and more complete symptom relief. SN - 1423-0097 UR - https://www.unboundmedicine.com/medline/citation/30677766/Efficacy_of_a_Novel_Intranasal_Formulation_of_Azelastine_Hydrochloride_and_Fluticasone_Propionate_Delivered_in_a_Single_Spray_for_the_Treatment_of_Seasonal_Allergic_Rhinitis:_Results_from_Russia_ L2 - https://www.karger.com?DOI=10.1159/000494507 DB - PRIME DP - Unbound Medicine ER -

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