Advanced search
Publication Cover
Journal of Asthma and Allergy Volume 16, 2023 - Issue
Submit an article Journal homepage
281
Views
0
CrossRef citations to date
0
Altmetric
ORIGINAL RESEARCH

The Comparative Bioavailability of Fluticasone and Azelastine Delivered as a Single Fixed Dose Combination (MP-AzeFlu) in Comparison to Two Different Formulations of Azelastine and Fluticasone Propionate Following Intranasal Administration in Healthy Chinese Volunteers

Wenyuan Qi1 Clinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China;2 Assessment of Clinical Drugs Risk and Individual Application Key Laboratory, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of ChinaView further author information
,
Yue Liu1 Clinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China;2 Assessment of Clinical Drugs Risk and Individual Application Key Laboratory, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of ChinaView further author information
,
Wei Xue1 Clinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China;2 Assessment of Clinical Drugs Risk and Individual Application Key Laboratory, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of ChinaView further author information
,
Kexin Li1 Clinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China;2 Assessment of Clinical Drugs Risk and Individual Application Key Laboratory, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of ChinaCorrespondence[email protected]
View further author information
,
J Christopher Gorski3 Global Clinical Pharmacology, Mylan Pharmacetical Inc. (Now Viatris), Morgantown, WV, USAView further author information
,
Mark Liu3 Global Clinical Pharmacology, Mylan Pharmacetical Inc. (Now Viatris), Morgantown, WV, USAView further author information
,
Tieliang Yan3 Global Clinical Pharmacology, Mylan Pharmacetical Inc. (Now Viatris), Morgantown, WV, USAView further author information
,
Duc Tung Nguyen4 Global Clinical Sciences, MEDA Pharma GmbH & Co. KG (A Viatris Company), Bad-Homburg, GermanyView further author information
&
Rajesh Kumar Ramalingam5 Global Medical Affairs, Mylan Pharmaceuticals Private Limited (Now Viatris), Bengaluru, IndiaORCID Iconhttps://orcid.org/0000-0003-0690-1283View further author information
ORCID Icon show all
Pages 667-677 | Received 06 Apr 2023, Accepted 14 Jun 2023, Published online: 30 Jun 2023

References

  • Price D, Shah S, Bhatia S, et al. A new therapy (MP29-02) is effective for the long-term treatment of chronic rhinitis. J Invest Allergol Clin Immunol. 2013;23(7):495–503.
  • Li W, Wang Y, Pei Y, Xia Y. Pharmacokinetics and bioequivalence evaluation of two montelukast sodium chewable tablets in healthy Chinese volunteers under fasted and fed conditions. Drug Des Devel Ther. 2021;15:1091–1099. doi:10.2147/DDDT.S298355
  • 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.e73. doi:10.1016/j.jaci.2019.06.049
  • 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 e1726. doi:10.1016/j.jaip.2018.01.031
  • Bousquet J, Schunemann HJ, Fonseca J, et al. MACVIA-ARIA Sentinel NetworK for allergic rhinitis (MASK-rhinitis): the new generation guideline implementation. Allergy. 2015;70(11):1372–1392. doi:10.1111/all.12686
  • Williams PB, Crandall E, Sheppard JD. Azelastine hydrochloride, a dual-acting anti-inflammatory ophthalmic solution, for treatment of allergic conjunctivitis. Clin Ophthalmol. 2010;4:993–1001. doi:10.2147/OPTH.S13479
  • Ciprandi G, Pronzato C, Passalacqua G, et al. Topical azelastine reduces eosinophil activation and intercellular adhesion molecule-1 expression on nasal epithelial cells: an antiallergic activity. J Allergy Clin Immunol. 1996;98(6):1088–1096. doi:10.1016/S0091-6749(96)80196-5
  • Berger WE, Mustakov TB, Kralimarkova TZ, Christoff G, Popov TA. Treatment with azelastine hydrochloride and fluticasone propionate in a single delivery device of young children and adolescents with allergic rhinitis. Paper presented at: Allergy Asthma Proc; 2020.
  • Mollmann H, Wagner M, Meibohm B, et al. Pharmacokinetic and pharmacodynamic evaluation of fluticasone propionate after inhaled administration. Eur J Clin Pharmacol. 1998;53(6):459–467. doi:10.1007/s002280050407
  • McKeage K, Keam SJ. Salmeterol/fluticasone propionate: a review of its use in asthma. Drugs. 2009;69(13):1799–1828. doi:10.2165/11202210-000000000-00000
  • Vicens-Artes S, Roca-Ferrer J, Tubita V, et al. Superior effect of MP-AzeFlu compared to monotherapy with fluticasone propionate or azelastine on GILZ, MKP-1 and TTP anti-inflammatory gene expression in healthy and inflamed upper airway mucosa. Clin Exp Allergy. 2022;52(6):788–791. doi:10.1111/cea.14099
  • Berger WE, Shah S, Lieberman P, et al. Long-term, randomized safety study of MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate in an advanced delivery system) in subjects with chronic rhinitis. J Allergy Clin Immunol Pract. 2014;2(2):179–185. doi:10.1016/j.jaip.2013.09.019
  • 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
  • Food and Drug Administration. Guidance for Industry Drug Interaction Studies —Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations. Food and Drug Administration; 2012.
  • McTavish D, Sorkin EM. Azelastine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential. Drugs. 1989;38(5):778–800. doi:10.2165/00003495-198938050-00005
  • Thorsson L, Dahlstrom K, Edsbacker S, Kallen A, Paulson J, Wiren JE. Pharmacokinetics and systemic effects of inhaled fluticasone propionate in healthy subjects. Br J Clin Pharmacol. 1997;43(2):155–161. doi:10.1046/j.1365-2125.1997.d01-1425.x
  • Hochhaus G. New developments in corticosteroids. Proc Am Thorac Soc. 2004;1(3):269–274. doi:10.1513/pats.200402-007MS
  • Ding X, Kaminsky LS. Human extrahepatic cytochromes P450: function in xenobiotic metabolism and tissue-selective chemical toxicity in the respiratory and gastrointestinal tracts. Annu Rev Pharmacol Toxicol. 2003;43(1):149–173. doi:10.1146/annurev.pharmtox.43.100901.140251

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.