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Onset of Action of the Fixed Combination Intranasal Azelastine-Fluticasone Propionate in an Allergen Exposure Chamber.
J Allergy Clin Immunol Pract. 2018 Sep - Oct; 6(5):1726-1732.e6.JA

Abstract

BACKGROUND

A fixed-dose combination of intranasal azelastine hydrochloride and fluticasone propionate (MP-AzeFlu) is the most effective treatment of allergic rhinitis, but its onset of action requires further investigation.

OBJECTIVE

To compare the onset of action of MP-AzeFlu with the free combination of oral loratadine (LORA) and intranasal fluticasone propionate (INFP).

METHODS

In this single-center, randomized, placebo-controlled, double-blind, double-dummy, 3-period crossover trial, allergic rhinitis symptoms were induced in asymptomatic patients by ragweed pollen challenge in an allergen environmental exposure chamber. Patients received single-dose MP-AzeFlu, LORA/INFP, or placebo and were monitored for 4 hours. The primary outcome was onset of action measured by total nasal symptom score (TNSS). Secondary measures were total ocular symptom score (TOSS), total score of the 7 nasal and ocular symptoms (T7SS), and the global visual analog scale (VAS).

RESULTS

The full analysis set included 82 patients, of which 78 completed all treatments. TNSS was significantly reduced versus placebo from 5 minutes for MP-AzeFlu and 150 minutes for LORA/INFP onward (both P < .05) till the end of assessment (0-4 hours). MP-AzeFlu reduced TNSS to a greater extent at each time point from 5 to 90 minutes (P < .05) and over the entire assessment interval (P ≤ .005) versus LORA/INFP or placebo. No statistically significant difference between LORA/INFP and placebo was observed over the assessment interval (P = .182). The onset of action of MP-AzeFlu assessed by TOSS, T7SS, and VAS was 10 minutes, 2 hours earlier than with LORA/INFP.

CONCLUSION

MP-AzeFlu had a more rapid onset of action (5 minutes) and was more effective than LORA/INFP.

Authors+Show Affiliations

MACVIA-France, Contre les MAladies Chroniques pour un VIeillissement Actif en France European Innovation Partnership on Active and Healthy Ageing Reference Site, Montpellier, France; INSERM U 1168, VIMA: Ageing and chronic diseases Epidemiological and public health approaches, Villejuif, Université Versailles St-Quentin-en-Yvelines; Euforea, Brussels, Belgium; Charité, Berlin, Germany. Electronic address: jean.bousquet@orange.fr.Allergy and Asthma Medical Group and Research Center, San Diego, Calif.Inflamax Research, Mississaugua, Ontario, Canada.Mylan, Canonsburg, Pa.Meda Pharma GmbH & Co. KG (a Mylan Company), Bad Homurg, Germany.Meda Pharma GmbH & Co. KG (a Mylan Company), Bad Homurg, Germany.Meda Pharma GmbH & Co. KG (a Mylan Company), Bad Homurg, Germany.Meda Pharma GmbH & Co. KG (a Mylan Company), Bad Homurg, Germany.Allergy and Asthma Medical Group and Research Center, San Diego, Calif.Observational and Pragmatic Research Institute, Singapore; Optimum Patient Care, Cambridge, UK; Academic Centre of Primary Care, University of Aberdeen, Aberdeen, UK.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29425904

Citation

Bousquet, Jean, et al. "Onset of Action of the Fixed Combination Intranasal Azelastine-Fluticasone Propionate in an Allergen Exposure Chamber." The Journal of Allergy and Clinical Immunology. in Practice, vol. 6, no. 5, 2018, pp. 1726-1732.e6.
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.
Bousquet, J., Meltzer, E. O., Couroux, P., Koltun, A., Kopietz, F., Munzel, U., Kuhl, H. C., Nguyen, D. T., Salapatek, A. M., & Price, D. (2018). Onset of Action of the Fixed Combination Intranasal Azelastine-Fluticasone Propionate in an Allergen Exposure Chamber. The Journal of Allergy and Clinical Immunology. in Practice, 6(5), 1726-e6. https://doi.org/10.1016/j.jaip.2018.01.031
Bousquet J, 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. PubMed PMID: 29425904.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Onset of Action of the Fixed Combination Intranasal Azelastine-Fluticasone Propionate in an Allergen Exposure Chamber. AU - Bousquet,Jean, AU - Meltzer,Eli O, AU - Couroux,Peter, AU - Koltun,Arkady, AU - Kopietz,Ferdinand, AU - Munzel,Ullrich, AU - Kuhl,Hans Christian, AU - Nguyen,Duc Tung, AU - Salapatek,Anne Marie, AU - Price,David, Y1 - 2018/02/07/ PY - 2017/11/10/received PY - 2018/01/14/revised PY - 2018/01/19/accepted PY - 2018/2/10/pubmed PY - 2019/11/15/medline PY - 2018/2/10/entrez KW - Allergic rhinitis KW - Azelastine KW - Environmental exposure chamber KW - Fluticasone propionate KW - Loratadine KW - Onset of action SP - 1726 EP - 1732.e6 JF - The journal of allergy and clinical immunology. In practice JO - J Allergy Clin Immunol Pract VL - 6 IS - 5 N2 - BACKGROUND: A fixed-dose combination of intranasal azelastine hydrochloride and fluticasone propionate (MP-AzeFlu) is the most effective treatment of allergic rhinitis, but its onset of action requires further investigation. OBJECTIVE: To compare the onset of action of MP-AzeFlu with the free combination of oral loratadine (LORA) and intranasal fluticasone propionate (INFP). METHODS: In this single-center, randomized, placebo-controlled, double-blind, double-dummy, 3-period crossover trial, allergic rhinitis symptoms were induced in asymptomatic patients by ragweed pollen challenge in an allergen environmental exposure chamber. Patients received single-dose MP-AzeFlu, LORA/INFP, or placebo and were monitored for 4 hours. The primary outcome was onset of action measured by total nasal symptom score (TNSS). Secondary measures were total ocular symptom score (TOSS), total score of the 7 nasal and ocular symptoms (T7SS), and the global visual analog scale (VAS). RESULTS: The full analysis set included 82 patients, of which 78 completed all treatments. TNSS was significantly reduced versus placebo from 5 minutes for MP-AzeFlu and 150 minutes for LORA/INFP onward (both P < .05) till the end of assessment (0-4 hours). MP-AzeFlu reduced TNSS to a greater extent at each time point from 5 to 90 minutes (P < .05) and over the entire assessment interval (P ≤ .005) versus LORA/INFP or placebo. No statistically significant difference between LORA/INFP and placebo was observed over the assessment interval (P = .182). The onset of action of MP-AzeFlu assessed by TOSS, T7SS, and VAS was 10 minutes, 2 hours earlier than with LORA/INFP. CONCLUSION: MP-AzeFlu had a more rapid onset of action (5 minutes) and was more effective than LORA/INFP. SN - 2213-2201 UR - https://www.unboundmedicine.com/medline/citation/29425904/Onset_of_Action_of_the_Fixed_Combination_Intranasal_Azelastine_Fluticasone_Propionate_in_an_Allergen_Exposure_Chamber_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S2213-2198(18)30058-8 DB - PRIME DP - Unbound Medicine ER -