Perennial Allergic Rhinitis Study In Pediatric Subjects

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Rhinitis, Allergic, Perennial

Treatments: Drug: GW685698X

Study type: Interventional

Funder types: Industry

Identifiers

NCT00108914

FFR30008

Details and patient eligibility

About

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

Full 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)

Enrollment: 558 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of perennial allergic rhinitis.

Exclusion criteria

• Have significant concomitant medical conditions.
• Use of corticosteroids or other allergy medications during the study.
• Have abnormal ECG.
• Have laboratory abnormality.
• Have abnormal eye exam.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind