Evaluation of Efficacy of Dellegra® Combination Tablet (Fexofenadine Hydrochloride 30mg /Pseudoephedrine Hydrochloride 60mg) in Allergic Rhinitis After Japanese Cedar Antigen Exposure in Japanese Population. Open Label Study

NCT02175485 Phase 4 COMPLETED

Primary Objective: To collect and analyze clinical data of Allergic Rhinitis patients' Total Nasal Symptom Score (TNSS) change after Dellegra internal use under high density pure Japanese cedar pollen exposure. Secondary Objective: To collect and analyze clinical data of Allergic Rhinitis patients' change in Total Symptom Score (TSS) and amount of nasal discharge, safety, and overall patients' impression about efficacy of Dellegra after Dellegra internal use under high density pure Japanese cedar pollen exposure.

Details

Lead sponsor	Sanofi
Phase	Phase 4
Status	COMPLETED
Enrolment	24
Start date	2014-06
Completion	2014-06

Conditions

• Rhinitis Allergic

Interventions

• Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg

Primary outcomes

• Mean change in Total Nasal Symptom Score (sneezing, nasal discharge, nasal congestion, and itchy nose — From 2 hours after antigen exposure (baseline) to 3 hours after intake of Dellegra

Countries

Japan