Clinical efficacy and safety of fixed-dose intranasal combination of azelastine hydrochloride and fluticasone propionate for treatment of seasonal allergic rhinitis

Cover Page


Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription or Fee Access

Abstract

Allergic rhinitis is a common chronic respiratory disease that affects millions of people worldwide and has a significant impact on their quality of life, productivity, and performance. Achieving control of the symptoms of moderate/severe allergic rhinitis, which often requires the use of several drugs from different pharmacological groups, is particularly challenging.

The article considers clinical efficacy and safety of fixed-dose intranasal combination of azelastine hydrochloride and fluticasone propionate for treatment of seasonal allergic rhinitis. The combination of azelastine hydrochloride and fluticasone propionate demonstrates a synergistic effect in improving the symptoms of both early and late allergic reactions and has a pronounced anti-inflammatory effect. Studies show that the use of fixed-dose combination of azelastine hydrochloride and fluticasone propionate significantly improves nasal and ocular symptoms of seasonal allergic rhinitis compared to fluticasone propionate and azelastine hydrochloride monotherapies. The drug acts quickly and provides sustained relief of symptoms which contributes to improved quality of life for the patients.

The article provides an overview of the main preclinical, clinical randomized trials and studies in real clinical practice on the efficacy and safety of the fixed-dose intranasal combination, especially in comparison with monotherapies with the drugs included in the combination and placebo. It demonstrates its effectiveness in different populations regardless of race, gender and age, and in long-term use. Azelastine hydrochloride in combination with fluticasone propionate has the most extensive body of evidence of its efficacy, including studies conducted in the Russian patient population. The drug can be used in patients from the age of 12 years with moderate to severe seasonal allergic rhinitis. It is included in all international and Russian guidelines on allergic rhinitis.

Full Text

Restricted Access

About the authors

Natalya M. Nenasheva

Russian Medical Academy of Continuous Professional Education

Email: 1444031@gmail.com
ORCID iD: 0000-0002-3162-2510
SPIN-code: 3363-6170

MD, Dr. Sci. (Medicine), Professor

Россия, Moscow

Oksana V. Sebekina

Russian Medical Academy of Continuous Professional Education; City Clinical Hospital No. 24

Email: Sebekin1@mail.ru
ORCID iD: 0000-0002-3508-9602
SPIN-code: 2922-9398

MD, Cand. Sci. (Medicine), Associate Professor

Россия, Moscow; Moscow

Marina Yu. Peredelskaya

Russian Medical Academy of Continuous Professional Education; City Clinical Hospital No. 24

Author for correspondence.
Email: concy1984@gmail.com
ORCID iD: 0000-0003-2682-8108
SPIN-code: 3363-5507
Scopus Author ID: 57210586164

MD, Cand. Sci. (Med.)

Россия, 2/1 Barrikadnaya street, 125993 Moscow; Moscow

References

  1. Аллергический ринит. Федеральные клинические рекомендации. Российская ассоциация аллергологов и клинических иммунологов; Союз педиатров России; Национальная медицинская ассоциация оториноларингологов. 2024. Режим доступа: https://cr.minzdrav.gov.ru/preview-cr/261_2 Дата обращения: 04.03.2025.
  2. Wise SK, Damask C, Roland LT, et al. International consensus statement on allergy and rhinology: allergic rhinitis — 2023. Int Forum Allergy Rhinol. 2023;13(4):293–859. doi: 10.1002/alr.23090 EDN: DNJRZX
  3. Shilenkova VV, Nenasheva NM. Allergic rhinitis: what is the patient’s choice of drug based on? Russian study’s results. Russian Bulletin of Otorhinolaryngology. 2021;86(2):54–61. (In Russ.) doi: 10.17116/otorino20218602154 EDN: QMTFDK
  4. Arcimowicz M. Allergic rhinitis — effective treatment according to the latest recommendations. Otolaryngol Pol. 2022;76(6):45–59. doi: 10.5604/01.3001.0016.1488 EDN: DYMWWV
  5. Bousquet J, Schünemann HJ, Togias A, et al. Next-generation Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines for allergic rhinitis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE) and real-world evidence. J Allergy Clin Immunol. 2020;145(1):70–80.e3. doi: 10.1016/j.jaci.2019.06.049 EDN: USDAXA
  6. Klimek L, Berger WE, Bousquet J, et al. MP-AzeFlu in moderate-to-severe allergic rhinitis: a literature review. Int Arch Allergy Immunol. 2021;182(11):1026–1035. doi: 10.1159/000516417 EDN: XCRKCG
  7. Van Bulck P, Cools L, Soumya MS, et al. A multicenter real-life study on the multiple reasons for uncontrolled allergic rhinitis. Int Forum Allergy Rhinol. 2021;11(10):1452–1460. doi: 10.1002/alr.22808 EDN: MHEFPC
  8. Tantilipikorn P, Kirtsreesakul V, Bunnag C, et al. The use of azelastine hydrochloride/fluticasone propionate in the management of allergic rhinitis in Asia: a review. J Asthma Allergy. 2024;17:667–679. doi: 10.2147/JAA.S451733 EDN: DFZJNB
  9. Meltzer EO, Bukstein DA. The economic impact of allergic rhinitis and current guidelines for treatment. Ann Allergy Asthma Immunol. 2011;106(2):S12–S16. doi: 10.1016/j.anai.2010.10.014 EDN: OMVPRF
  10. Bachert C, Bousquet J, Hellings P. Rapid onset of action and reduced nasal hyperreactivity: new targets in allergic rhinitis management. Clin Transl Allergy. 2018;8:25. doi: 10.1186/s13601-018-0210-2 EDN: YJACXJ
  11. Shilenkova VV, Lopatin AS. Allergic rhinitis and quality of life. Russian Rhinology. 2019;27(4):215–223. (In Russ.) doi: 10.17116/rosrino201927041215 EDN: OEKNMA
  12. Ratner PH, Hampel F, Van Bavel J, et al. Combination therapy with azelastine hydrochloride nasal spray and fluticasone propionate nasal spray in the treatment of patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2008;100(1):74–81. doi: 10.1016/S1081-1206(10)60408-5
  13. Дуоназе. Регистрационное удостоверение ЛП-№(004130)-(РГ-RU). Государственный реестр лекарственных средств. Режим доступа: https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=712b8380-1951-4997-aba3-bd9c05944750 Дата обращения: 05.03.2024.
  14. Roca-Ferrer J, Pujols L, Pérez-González M, et al. Superior effect of MP-AzeFlu than azelastine or fluticasone propionate alone on reducing inflammatory markers. Allergy Asthma Clin Immunol. 2018;14:86. doi: 10.1186/s13223-018-0311-4 EDN: WYGQEK
  15. Derendorf H, Munzel U, Petzold U, et al. Bioavailability and disposition of azelastine and fluticasone propionate when delivered by MP29-02, a novel aqueous nasal spray. Br J Clin Pharmacol. 2012;74(1):125–133. doi: 10.1111/j.1365-2125.2012.04222.x EDN: PHUMIH
  16. Dymista: package insert / prescribing information. Available from: https://www.drugs.com/pro/dymista.html Accessed: 17.03.2025.
  17. Klimek L, Poletti SC, Sperl A, et al. Olfaction in patients with allergic rhinitis: an indicator of successful MP-AzeFlu therapy. Int Forum Allergy Rhinol. 2017;7(3):287–292. doi: 10.1002/alr.21877 EDN: YXCOER
  18. 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):1282–1289e10. doi: 10.1016/j.jaci.2012.01.077 EDN: PHULYH
  19. 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. doi: 10.1159/000494507 EDN: NTBVMK
  20. Zhong Z, Xun Y, Shi X, et al. Clinical efficacy and safety of MP-AzeFlu for the treatment of allergic rhinitis: a meta-analysis. Eur Arch Otorhinolaryngol. 2022;279(5):2457–2464. doi: 10.1007/s00405-021-07048-1 EDN: OTXYIZ
  21. Bousquet J, Meltzer EO, Couroux P, et al. Onset of action of the fixed combination intranasal azelastine-fluticasone propionate in an allergen exposure chamber. J Allergy Clin Immunol Pract. 2018;6(5):1726–1732.e6. doi: 10.1016/j.jaip.2018.01.031 EDN: YIKQHB
  22. Klimek L, Bachert C, Stjärne P, et al. MP-AzeFlu provides rapid and effective allergic rhinitis control in real life: a pan-European study. Allergy Asthma Proc. 2016;37(5):376–386. doi: 10.2500/aap.2016.37.3979 EDN: XUJWOB
  23. Kaulsay R, Nguyen DT, Kuhl HC. Real-life effectiveness of MP-AzeFlu in Irish patients with persistent allergic rhinitis, assessed by visual analogue scale and endoscopy. Immun Inflamm Dis. 2018;6(4):456–464. doi: 10.1002/iid3.237 EDN: WWVATS
  24. Bousquet J, Khaltaev N, Cruz AA, et al. Allergic rhinitis and its impact on asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008;63(Suppl 86):8–160. doi: 10.1111/j.1398-9995.2007.01620.x EDN: UHLDGP
  25. Walker S, Khan-Wasti S, Fletcher M, et al. Seasonal allergic rhinitis is associated with a detrimental effect on examination performance in United Kingdom teenagers: case-control study. J Allergy Clin Immunol. 2007;120(2):381–387. doi: 10.1016/j.jaci.2007.03.034
  26. Maspero J, Lee BW, Katelaris CH, et al. Quality of life and control of allergic rhinitis in patients from regions beyond western Europe and the United States. Clin Exp Allergy. 2012;42(12):1684–1696. doi: 10.1111/j.1365-2222.2012.04025.x EDN: RGLGVD
  27. 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):324–332. doi: 10.2500/aap.2012.33.3587 EDN: RJCNYJ
  28. Hampel FC, Ratner PH, Van Bavel J, et al. Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device. Ann Allergy Asthma Immunol. 2010;105(2):168–173. doi: 10.1016/j.anai.2010.06.008
  29. Van Weissenbruch R, Klimek L, Gálffy G, et al. MP-AzeFlu improves the quality-of-life of patients with allergic rhinitis. J Asthma Allergy. 2020;13:633–645. doi: 10.2147/JAA.S277734 EDN: QVNNJA
  30. Berger W, Sher E, Gawchik S, Fineman S. Safety of a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate in children: a randomized clinical trial. Allergy Asthma Proc. 2018;39(2):110–116. doi: 10.2500/aap.2018.39.4116 EDN: YHACHZ
  31. Ekstedt S, Kumlien Georén S, Cardell LO. Effects of MP-AzeFlu enhanced by activation of bitter taste receptor TAS2R. Allergy Asthma Clin Immunol. 2020;16(1):45. doi: 10.1186/s13223-020-00438-w EDN: KFWHZG

Supplementary files

Supplementary Files
Action
1. JATS XML
Download
2. Fig. 1. Mean change from baseline in combination (morning + evening) 12-hour total nasal symptom score (rTNSS) over 14 days of treatment.

Download (138KB)
Indexing metadata
3. Fig. 2. Daily change in the combined assessment of total nasal symptoms (rTNSS) compared to baseline.

Download (180KB)
Indexing metadata
4. Fig 3. Dynamics of the level of total nasal symptoms (TNSS) before allergen provocation in the chamber and during the subsequent 12 hours (a) and comparison with fluticasone propionate and loratadine alone and placebo (b).

Download (402KB)
Indexing metadata
5. Fig. 4. Mean improvement from baseline in total nasal symptoms during the 14-day study period (negative values indicate improvement).

Download (157KB)
Indexing metadata

Copyright © ABV-press, 2025

License URL: https://eco-vector.com/for_authors.php#07

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies