A Study To Evaluate The Efficacy And Safety Of A Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR).

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 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 Years of Age and Older) With Perennial Allergic Rhinitis (PAR)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00103454

Enrollment

288

Registered

2005-02-09

Start date

2005-01-31

Completion date

2005-05-31

Last updated

2016-09-19

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

Conditions

Rhinitis, Allergic, Perennial

Keywords

allergic rhinitis, GW685698X, Perennial Allergic Rhinitis

Brief summary

The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).

Detailed description

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 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Perennial Allergic Rhinitis (PAR)

Interventions

DRUGGW685698X

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of perennial allergic rhinitis (PAR). * Must comply with study procedures and be literate.

Exclusion criteria

* Significant concomitant medical conditions. * Use of corticosteroids. * Use of allergy medications and some other medications during the study. * Current tobacco use. * Clinically significant abnormal ECG or laboratory abnormality.

Design outcomes

Primary

Measure	Time frame
Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores. Subjects complete diaries twice daily (every 12 hours) reporting the severity of their PAR symptoms.	—

Secondary

Measure	Time frame
Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. The subject completes an overall evaluation of response to therapy during the last clinic visit.	—

Countries

Canada, United States

Outcome results

None listed

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