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

Publication date: Available online 7 February 2018
Source:The Journal of Allergy and Clinical Immunology: In Practice
Author(s): Jean Bousquet, Eli Meltzer, Peter Couroux, Arkady Koltun, Ferdinand Kopietz, Ullrich Munzel, Hans Christian Kuhl, Duc Tung Nguyen, Anne Marie Salapatek, David Price
BackgroundA 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.ObjectivesThis study compared onset of action of MP-AzeFlu with the free combination of oral loratadine and intranasal fluticasone propionate (LORA/INFP).MethodsIn 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).ResultsThe 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.ConclusionMP-AzeFlu had a more rapid onset of action (5 minutes) and was more effective than LORA/INFP.Registration of the trialClinicalTrials.gov Identifier: NCT03004131; Key words: allergic rhinitis, azelastine, environmental exposure chamber, fluticasone propionate, loratadine, onset of action