Efficacy of Admixing Azelastine-Fluticasone into Saline Irrigation versus Saline Alone for Allergic Rhinitis: A Randomized Double-Blind Controlled Trial
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Abstract
Objectives: To determine whether admixing a fixed-dose combination of azelastine hydrochloride and fluticasone propionate (MP-AzeFlu) directly into high-volume saline irrigation provides superior clinical outcomes compared with saline irrigation alone in patients with moderate-to-severe allergic rhinitis (AR).
Materials and Methods: Forty adults with moderate-to-severe AR were randomized (1:1) to the admixture or control group in this prospective, double-blind, randomized controlled trial. The admixture group mixed four actuations of MP-AzeFlu with 120 mL of isotonic saline per irrigation session and performed nasal irrigation twice daily (eight actuations per day; 548 µg azelastine and 200 µg fluticasone per session, for daily totals of 1,096 µg azelastine and 400 µg fluticasone). The control group followed an identical protocol with a matched isotonic saline control spray. Efficacy was assessed using the 22-item Sinonasal Outcome Test (SNOT-22), visual analog scale (VAS), Modified Lund–Kennedy endoscopic score, and acoustic rhinometry at baseline and at 2 and 4 weeks.
Results: Both groups demonstrated statistically significant improvements in SNOT-22 and VAS scores from baseline (p < 0.001). However, no statistically significant between-group differences were observed for SNOT-22 (coefficient, 1.06; 95% confidence interval, −2.25 to 4.38; p = 0.529), VAS (coefficient, −0.03; 95% confidence interval, −0.85 to 0.79; p = 0.937), Modified Lund–Kennedy endoscopic score (coefficient, −0.05; 95% confidence interval, −0.30 to 0.20; p = 0.700), or acoustic rhinometry parameters (all p > 0.05). No serious adverse events were reported in either group.
Conclusion: In this trial, MP-AzeFlu admixture did not demonstrate a therapeutic advantage over saline irrigation alone. The lack of additive benefit may possibly be attributable to excessive dilution and insufficient mucosal contact time, although the exact mechanism was not directly evaluated in this study. These findings do not support routine use of this off-label admixture protocol. Further comparative studies are needed to determine the optimal delivery strategy for intranasal therapy.
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References
Dierick BJH, van der Molen T, Flokstra-de Blok BMJ, Muraro A, Postma MJ, Kocks JWH, et al. Burden and socioeconomics of asthma, allergic rhinitis, atopic dermatitis and food allergy. Expert Rev Pharmacoecon Outcomes Res 2020;20(5):437–53.
Bunnag C, Jareoncharsri P, Tantilipikorn P, Vichyanond P, Pawankar R. Epidemiology and current status of allergic rhinitis and asthma in Thailand -- ARIA Asia-Pacific workshop report. Asian Pac J Allergy Immunol 2009;27(1):79–86.
Brozek JL, Bousquet J, Agache I, Agarwal A, Bachert C, Bosnic-Anticevich S, et al. Allergic rhinitis and its impact on asthma (ARIA) guidelines-2016 revision. J Allergy Clin Immunol 2017;140(4):950–8.
Seidman MD, Gurgel RK, Lin SY, Schwartz SR, Baroody FM, Bonner JR, et al. Clinical practice guideline: Allergic rhinitis. Otolaryngol Head Neck Surg 2015;152(1 Suppl):S1–43.
Head K, Snidvongs K, Glew S, Scadding G, Schilder AG, Philpott C, et al. Saline irrigation for allergic rhinitis. Cochrane Database Syst Rev 2018;6(6):CD012597.
Harvey RJ, Snidvongs K, Kalish LH, Oakley GM, Sacks R. Corticosteroid nasal irrigations are more effective than simple sprays in a randomized double-blinded placebo-controlled trial for chronic rhinosinusitis after sinus surgery. Int Forum Allergy Rhinol 2018;8(4):461–70.
Periasamy N, Pujary K, Bhandarkar AM, Bhandarkar ND, Ramaswamy B. Budesonide vs saline nasal irrigation in allergic rhinitis: a randomized placebo-controlled trial. Otolaryngol Head Neck Surg 2020;162(6):979–84.
Carr W, Bernstein J, Lieberman P, Meltzer E, Bachert C, Price D, et al. A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis. J Allergy Clin Immunol 2012;129(5):1282–9.e10.
Derendorf H, Munzel U, Petzold U, Maus J, Mascher H, Hermann R, 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):125–33.
Li S, Xu R, Yu S, Wang M, Fan J, Chen M, et al. Nasal saline irrigation with azelastine-fluticasone nasal spray in moderate-tosevere persistent allergic rhinitis: a randomized controlled trial. Front Allergy 2025;6:1622510.
Ishak MN, Md Shukri N, Ramli RR. The effectiveness of Budesonide nasal irrigation in patients with allergic rhinitis. Malays J Med Sci 2022;29(1):34–42.
Chowdhury NI, Mace JC, Bodner TE, Alt JA, Deconde AS, Levy JM, et al. Investigating the minimal clinically important difference for SNOT-22 symptom domains in surgically managed chronic rhinosinusitis. Int Forum Allergy Rhinol 2017;7(12):1149–55.
Roca-Ferrer J, Pujols L, Perez-Gonzalez M, Alobid I, Callejas B, Vicens-Artes S, et al. Superior effect of MP-AzeFlu than azelastine or fluticasone propionate alone on reducing inflammatory markers. Allergy Asthma Clin Immunol 2018;14:86.
Shah S, Berger W, Lumry W, La Force C, Wheeler W, Sacks H. Efficacy and safety of azelastine 0.15% nasal spray and azelastine 0.10% nasal spray in patients with seasonal allergic rhinitis. Allergy Asthma Proc 2009;30(6):628–33.
Chong LY, Head K, Hopkins C, Philpott C, Glew S, Scadding G, et al. Saline irrigation for chronic rhinosinusitis. Cochrane Database Syst Rev 2016;4(4):CD011995.
