NCT02175485

Evaluation of Efficacy of Dellegra in Exposure Unit

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

It will be 8 days at minimum and up to 17 days depending on screening visit and post-treatment observation allowances.

Conditions

• Rhinitis Allergic

Interventions

Type	Name	Description
DRUG	Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg	Pharmaceutical form:tablet Route of administration: oral

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-06-26
• Last updated: 2015-12-18

Locations

1 site across 1 country: Japan