A Two Week Randomized, Double Blind Placebo Controlled, Parallel Group Study of GW685698X Aqueous Nasal Spray 100mcg and 50mcg QD in Pediatric Subjects With Perennial Allergic Rhinitis

GlaxoSmithKline1 site in 1 country558 target enrollmentFebruary 2005

ConditionsRhinitis, Allergic, Perennial

DrugsGW685698X

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Rhinitis, Allergic, Perennial
Sponsor: GlaxoSmithKline
Enrollment: 558
Locations: 1
Primary Endpoint: Improvement in daily, reflective total nasal symptom scores after first 4-week treatment period in subjects ages 6 to <12 years.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

February 2005

End Date

November 2005

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.