Fixed-Dose Combination Intranasal Azelastine-Fluticasone Propionate Versus Oral Loratadine with Intranasal Fluticasone Propionate: Assessment of Onset of Action in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms
Monday, March 5, 2018
South Hall A2 (Convention Center)
Jean Bousquet, MD PhD, David Price, MD, Eli O. Meltzer, MD, Duc Tung Nguyen, PhD, Hans-Christian Kuhl, PhD, Arkady Koltun, MD, PhD, Ferdinand Kopietz, PhD, Ullrich Munzel, PhD
Rationale: Research has shown that a formulation of azelastine hydrochloride – fluticasone propionate in a single device (MP-AzeFlu) effectively treats allergic rhinitis (AR), but its onset of action (OOA) requires further investigation. This study compared MP-AzeFlu with 2 sequential monotherapies of oral loratadine and intranasal fluticasone propionate (LORA/INFP).

Methods: In this single-center (Ontario, Canada), randomized, double-blind, double-dummy, 3-period cross-over trial, AR was induced in asymptomatic, ragweed-sensitive patients by ragweed pollen challenge in an environmental exposure chamber. Patients receiving single-dose MP-AzeFlu, LORA/INFP, or placebo were monitored for 4 hours. Primary outcome was OOA (ie, first time point with greater efficacy change from baseline vs placebo and durable until last time point [240 min]) measured by total nasal symptom score (TNSS). Secondary measures included OOA assessed by total ocular symptom score (TOSS) and effect on individual nasal (itchy and runny nose, nasal congestion, and sneezing) and ocular (itchy, watery, and red eyes) symptom scores.

Results: Of the 82 patients in the full-analysis set, 78 completed treatment. TNSS was significantly reduced vs placebo from 5 min (MP-AzeFlu) and 150 min (LORA/INFP) through end of assessment (all P<0.05); similarly, OOA for TOSS was 10 min (MP-AzeFlu) and 120 min (LORA/INFP). All individual nasal and ocular symptoms contributed to these effects; generally, first time point with greater efficacy change from baseline vs placebo for individual symptoms was 5-15 min (MP-AzeFlu) and 120-180 min (LORA/INFP).

Conclusions: Overall, MP-AzeFlu had rapid onset of action (5 min) and was more effective than LORA/INFP.