Seasonal Allergic Rhinitis In Pediatric Subjects

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00107757

Enrollment

576

Registered

2005-04-08

Start date

2005-03-31

Completion date

2005-11-30

Last updated

2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis, Allergic, Perennial

Keywords

pediatric, Seasonal allergic rhinitis

Brief summary

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

Interventions

DRUGGW685698X

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026