Evaluation of Efficacy of Dellegra in Exposure Unit

Phase 4

Completed

• Conditions: Rhinitis Allergic
• Interventions: Drug: Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg

• Registration Number: NCT02175485
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Study First Submitted: 2014-06-22
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-26
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fexofenadine HCl	Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg	2 tablets of Dellegra Combination Tablets (Fexofenadine Hydrochloride 30 mg+Pseudoephedrine Hydrochloride 60 mg/tablet), oral, administrated 2 hours after start of exposure with 8,000 grains/cubic meter of Japanese cedar pollen

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Mean change of Total Symptom Score (sneezing, nasal discharge, nasal congestion, itchy nose, lacrimation, and eye itching	Prior to exposure, and every 15 minutes for 5 hours after exposure start
Overall patients' impression about efficacy of Dellegra after Dellegra internal use (Score 1 [none] to 7 [very severe])	From intake of Dellegra up to 17 days
Number of patients who experienced adverse events	From intake of Dellegra up to 17 days

Trial Locations

Locations (1)

Investigational Site Number 392-001; 🇯🇵 Shinjuku-ku, Japan