Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Perennial Allergic Rhinitis (PAR)

Phase 1

Active, not recruiting

Conditions: Rhinitis perennial
MedDRA version: 19.1Level: PTClassification code 10039094Term: Rhinitis perennialSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2017-000239-15-Outside-EU/EEA

Lead Sponsor: Sanofi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active

Sex: All

Target Recruitment: 100

Inclusion Criteria

•Aged 6 months through 11 years
•Patients with perennial allergic rhinitis

Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Neither serum specific IgE antibody or skin reaction is positive for the antigen of perennial allergy.
•Nasal symptom score is 0 for either sneezing or nasal discharge, or sum of these two score is less than 3, or nasal congestion score is 4.
•Patients with vasomotor rhinitis or eosinophilic rhinitis.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: •Number of patients with adverse events [ Time Frame: 4 weeks ] <br><br>•The number of clinically significant abnormalities for laboratory findings [ Time Frame: 4 weeks ] <br><br>;Main Objective: To evaluate safety (4 weeks);Secondary Objective: •To evaluate the long-term safety (12 weeks)<br>•To evaluate the efficacy<br>•To characterize the pharmacokinetic profile<br>;Primary end point(s): •Number of patients with adverse events<br><br>•The number of clinically significant abnormalities for laboratory findings <br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Number of patients with adverse events<br>•The number of clinically significant abnormalities for laboratory findings<br><br>•Changes from baseline in nasal symptom scores on patient diary<br><br>•Changes from baseline in nasal symptom severity scores assessed by investigator or subinvestigator <br><br>•Pharmacokinetic parameters of fexofenadine ;Timepoint(s) of evaluation of this end point: •Number of patients with adverse events [ Time Frame: 12 weeks ]<br><br>•The number of clinically significant abnormalities for laboratory findings [ Time Frame: 12 weeks ] <br><br>•Changes from baseline in nasal symptom scores on patient diary [ Time Frame: 4 weeks ]<br><br>•Changes from baseline in nasal symptom severity scores assessed by investigator or subinvestigator [ Time Frame: week 2 and 4 ]<br><br>•Pharmacokinetic parameters of fexofenadine [ Time Frame: week 4 and 12 ]