Perennial Allergic Rhinitis Study In Pediatric Subjects

Phase 3

Completed

• Conditions: Rhinitis, Allergic, Perennial

• Registration Number: NCT00108914
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to determine if the investigational drug is effective and safe in children with perennial allergic rhinitis.

Detailed Description

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 12 Weeks in Pediatric Subjects Ages 2 to \<12 Years with Perennial Allergic Rhinitis (PAR)

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-04-20
• Study First Submitted QC: 2005-04-20
• Study First Posted: 2005-04-21
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 558

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement in daily, reflective total nasal symptom scores after first 4-week treatment period in subjects ages 6 to <12 years.

Secondary Outcome Measures

Name	Time	Method
Improvement in AM, pre-dose, instantaneous total nasal symptom scores after first 4-week treatment period, overall evaluation of response to therapy for the first 4-week treatment period for subjects ages 6 to <12 years.

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇰 Nitra, Slovakia