Onset of action of the fixed combination intranasal azelastine-fluticasone propionate in an allergen exposure chamber

Jean Bousquet; Eli Meltzer; Peter Couroux; Arkady Koltun; Ferdinand Kopietz; Ullrich Munzel; Hans Christian Kuhl; Duc Tung Nguyen; Anne Marie Salapatek; David Price

doi:10.1016/j.jaip.2018.01.031

Onset of action of the fixed combination intranasal azelastine-fluticasone propionate in an allergen exposure chamber

Jean Bousquet (Corresponding Author), Eli Meltzer, Peter Couroux, Arkady Koltun, Ferdinand Kopietz, Ullrich Munzel, Hans Christian Kuhl, Duc Tung Nguyen, Anne Marie Salapatek, David Price

Research output: Contribution to journal › Article › peer-review

50 Citations (Scopus)

Abstract

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

OBJECTIVES: This study compared onset of action of MP-AzeFlu with the free combination of oral loratadine and intranasal fluticasone propionate (LORA/INFP).

METHODS: In this single-center randomized, placebo-controlled, double-blind, double-dummy, three-period crossover trial, AR 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 seven nasal and ocular symptoms (T7SS), and the global visual analogue scale (VAS).

RESULTS: The full analysis set included 82 patients; 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<0.05) until the end of assessment (0 to 4 hours). MP-AzeFlu reduced TNSS to a greater extent at each time point from 5 to 90 minutes (P<0.05) and over the entire assessment interval (P≤0.005) versus LORA/INFP or placebo. No statistically significant difference between LORA/INFP and placebo was observed over the assessment interval (P=0.182). MP-AzeFlu onset of action 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.

REGISTRATION OF THE TRIAL: ClinicalTrials.gov Identifier: NCT03004131; Key words: allergic rhinitis, azelastine, environmental exposure chamber, fluticasone propionate, loratadine, onset of action.

Original language	English
Pages (from-to)	1726-1732
Number of pages	7
Journal	The journal of allergy and clinical immunology. In practice
Volume	6
Issue number	5
Early online date	7 Feb 2018
DOIs	https://doi.org/10.1016/j.jaip.2018.01.031
Publication status	Published - 30 Sep 2018

Keywords

Journal Article
allergic rhinitis
azelastine
environmental exposure chamber
fluticasone propionate
loratadine
onset of action

Access to Document

10.1016/j.jaip.2018.01.031Licence: Unspecified

Cite this

Bousquet, J., Meltzer, E., 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), 1726-1732. https://doi.org/10.1016/j.jaip.2018.01.031

Bousquet, J, Meltzer, E, Couroux, P, Koltun, A, Kopietz, F, Munzel, U, Kuhl, HC, Nguyen, DT, Salapatek, AM & 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, vol. 6, no. 5, pp. 1726-1732. https://doi.org/10.1016/j.jaip.2018.01.031

@article{90f9b4783d954e45a9b1932899ba18b8,

title = "Onset of action of the fixed combination intranasal azelastine-fluticasone propionate in an allergen exposure chamber",

abstract = "BACKGROUND: A fixed-dose combination of intranasal azelastine hydrochloride-fluticasone propionate (MP-AzeFlu) is the most effective treatment of allergic rhinitis (AR), but its onset of action requires further investigation.OBJECTIVES: This study compared onset of action of MP-AzeFlu with the free combination of oral loratadine and intranasal fluticasone propionate (LORA/INFP).METHODS: In this single-center randomized, placebo-controlled, double-blind, double-dummy, three-period crossover trial, AR 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 seven nasal and ocular symptoms (T7SS), and the global visual analogue scale (VAS).RESULTS: The full analysis set included 82 patients; 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<0.05) until the end of assessment (0 to 4 hours). MP-AzeFlu reduced TNSS to a greater extent at each time point from 5 to 90 minutes (P<0.05) and over the entire assessment interval (P≤0.005) versus LORA/INFP or placebo. No statistically significant difference between LORA/INFP and placebo was observed over the assessment interval (P=0.182). MP-AzeFlu onset of action 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.REGISTRATION OF THE TRIAL: ClinicalTrials.gov Identifier: NCT03004131; Key words: allergic rhinitis, azelastine, environmental exposure chamber, fluticasone propionate, loratadine, onset of action.",

keywords = "Journal Article, allergic rhinitis, azelastine, environmental exposure chamber, fluticasone propionate, loratadine, onset of action",

author = "Jean Bousquet and Eli Meltzer and Peter Couroux and Arkady Koltun and Ferdinand Kopietz and Ullrich Munzel and Kuhl, {Hans Christian} and Nguyen, {Duc Tung} and Salapatek, {Anne Marie} and David Price",

note = "Copyright {\textcopyright} 2018. Published by Elsevier Inc.",

year = "2018",

month = sep,

day = "30",

doi = "10.1016/j.jaip.2018.01.031",

language = "English",

volume = "6",

pages = "1726--1732",

journal = "The Journal of Allergy and Clinical Immunology: In Practice",

issn = "2213-2198",

publisher = "Elsevier",

number = "5",

}

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

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

PY - 2018/9/30

Y1 - 2018/9/30

N2 - BACKGROUND: A fixed-dose combination of intranasal azelastine hydrochloride-fluticasone propionate (MP-AzeFlu) is the most effective treatment of allergic rhinitis (AR), but its onset of action requires further investigation.OBJECTIVES: This study compared onset of action of MP-AzeFlu with the free combination of oral loratadine and intranasal fluticasone propionate (LORA/INFP).METHODS: In this single-center randomized, placebo-controlled, double-blind, double-dummy, three-period crossover trial, AR 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 seven nasal and ocular symptoms (T7SS), and the global visual analogue scale (VAS).RESULTS: The full analysis set included 82 patients; 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<0.05) until the end of assessment (0 to 4 hours). MP-AzeFlu reduced TNSS to a greater extent at each time point from 5 to 90 minutes (P<0.05) and over the entire assessment interval (P≤0.005) versus LORA/INFP or placebo. No statistically significant difference between LORA/INFP and placebo was observed over the assessment interval (P=0.182). MP-AzeFlu onset of action 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.REGISTRATION OF THE TRIAL: ClinicalTrials.gov Identifier: NCT03004131; Key words: allergic rhinitis, azelastine, environmental exposure chamber, fluticasone propionate, loratadine, onset of action.

AB - BACKGROUND: A fixed-dose combination of intranasal azelastine hydrochloride-fluticasone propionate (MP-AzeFlu) is the most effective treatment of allergic rhinitis (AR), but its onset of action requires further investigation.OBJECTIVES: This study compared onset of action of MP-AzeFlu with the free combination of oral loratadine and intranasal fluticasone propionate (LORA/INFP).METHODS: In this single-center randomized, placebo-controlled, double-blind, double-dummy, three-period crossover trial, AR 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 seven nasal and ocular symptoms (T7SS), and the global visual analogue scale (VAS).RESULTS: The full analysis set included 82 patients; 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<0.05) until the end of assessment (0 to 4 hours). MP-AzeFlu reduced TNSS to a greater extent at each time point from 5 to 90 minutes (P<0.05) and over the entire assessment interval (P≤0.005) versus LORA/INFP or placebo. No statistically significant difference between LORA/INFP and placebo was observed over the assessment interval (P=0.182). MP-AzeFlu onset of action 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.REGISTRATION OF THE TRIAL: ClinicalTrials.gov Identifier: NCT03004131; Key words: allergic rhinitis, azelastine, environmental exposure chamber, fluticasone propionate, loratadine, onset of action.

KW - Journal Article

KW - allergic rhinitis

KW - azelastine

KW - environmental exposure chamber

KW - fluticasone propionate

KW - loratadine

KW - onset of action

U2 - 10.1016/j.jaip.2018.01.031

DO - 10.1016/j.jaip.2018.01.031

M3 - Article

C2 - 29425904

VL - 6

SP - 1726

EP - 1732

JO - The Journal of Allergy and Clinical Immunology: In Practice

JF - The Journal of Allergy and Clinical Immunology: In Practice

SN - 2213-2198

IS - 5

ER -

Onset of action of the fixed combination intranasal azelastine-fluticasone propionate in an allergen exposure chamber

Abstract

Keywords

Access to Document

Fingerprint

Cite this