Seasonal Allergic Rhinitis In Pediatric Subjects

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

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Key information

Conditions

Rhinitis, Allergic, Perennial Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Scottsdale, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of seasonal allergic rhinitis.
Adequate exposure to seasonal (Spring/Summer) allergen prevalent to the geographic area.

Exclusion criteria

Have significant concomitant medical conditions.
Use of corticosteroids, other allergy meds during the study.
Have abnormal ECG or laboratory abnormality.

Treatment and study plan

GW685698X

Drug

Primary outcomes

Improvement in daily, reflective total nasal symptom scores after 2 weeks of treatment in subjects ages 6 to <12 years.

Secondary outcomes

Improvement in AM, pre-dose, instantaneous total nasal symptom scores after 2 weeks of treatment, overall evaluation of response to therapy after 2 weeks of treatment for subjects ages 6 to <12 years.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Study completion: 2005
First posted: Apr 8, 2005
Registry last updated: Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed