Dymista Allergen Chamber - Onset of Action Study

Summary

This study is to assess the onset of action of fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray (Dymista) in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU).

Timeline

Start

2020-12-14

Primary completion

2021-12-04

Completion

2021-12-13

Outcome

Met primary endpoint

registry In this study, the first significant difference to placebo of TNSS was observed at 5 minutes time point (= onset of action). NCT04652245 ↗

registry analysis (superiority test); Treatment A (Dymista), Cross-over Design, Time-point 5 Min Post-dose (Onset of Action) vs Treatment B (Placebo), Cross-over Design, Time-point 5 Min Post-dose (Onset of Action); p = 0.028; ANCOVA NCT04652245 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azelastine	Small molecule	137 ug	Intranasal
Subject	Fluticasone	Other / unclassified	50 ug	Intranasal

Indications