A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults

A Randomized, Double-blind, Parallel Group, Placebo and Active (Prednisone) Controlled, 6-week Study of the Effect of Fluticasone Furoate Aqueous Nasal Spray 100mcg QD on the Hypothalamic Pituitary Adrenocortical (HPA) Axis in Adolescents and Adults 12 to 65 Years of Age With Perennial Allergic Rhinitis (PAR)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00116818

Enrollment

Registered

2005-07-01

Start date

2005-01-31

Completion date

2005-05-31

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

perennial allergic rhinitis, intranasal corticosteroid, HPA axis function, GW685698X

Brief summary

The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis. This study can last up to 6 weeks and you will come to the clinic up to 7 times. Clinic visits include physical examinations, vital sign assessments, clinical laboratory assessments, ECGs and allergy skin testing. You will need to complete a daily diary card and spend the night in the clinic on 2 occasions to collect urine and blood samples over 24 hour periods.

Detailed description

A randomized, double-blind, parallel group, placebo and active (prednisone) controlled, 6-week study of the effect of GW685698X aqueous nasal spray 100mcg QD on the hypothalamic pituitary adrenocortical (HPA) axis in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis (PAR).

Interventions

DRUGGW685698X aqueous nasal spray

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Diagnosis and history of perennial allergic rhinitis. * Must be willing to stay overnight in the clinic at the beginning and end of the study for the collection of urine and blood samples over 24 hours. * Must comply with all study procedures and be literate.

Exclusion criteria

* Use of tobacco products. * Work a rotating shift. * Significant concurrent medical conditions. * Certain medications such as corticosteroids and allergy medications.

Design outcomes

Primary

Measure	Time frame
HPA axis function at baseline and after 6 weeks of treatment as measured by 24 hour urine and serial serum cortisol assessments in domiciled subjects	—

Secondary

Measure	Time frame
Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.	—

Countries

Canada, United States

Outcome results

None listed

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