Long Term Safety Of GW685698X Via Nasal Biopsy

A Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray [Nasonex®] 200mcg QD), Parallel Group, Multi-Center, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD Via Nasal Biopsy in Subjects 18 Years of Age With Perennial Allergic Rhinitis (PAR)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00224523

Enrollment

125

Registered

2005-09-23

Start date

2005-09-30

Completion date

2007-02-28

Last updated

2016-10-28

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, nasal biopsy, GW685698X

Brief summary

Long term safety (52 weeks) of GW685698X on the nasal mucosa via nasal biopsy with an active control group (Nasonex®) and a healthy volunteers control group in subjects 18 years old with perennial allergic rhinitis . Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. Perennial allergic rhinitis is triggered by house dust mites, animal dander, etc., possibly causing symptoms year-round including nasal congestion, rhinorrhea and/or nasal itching.

Detailed description

A Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray \[Nasonex®\] 200mcg QD), Parallel Group, Multi-Center, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD via Nasal Biopsy in Subjects \>18 Years of Age with Perennial Allergic Rhinitis (PAR)

Interventions

DRUGGW685698X

DRUGmometasone furoate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* History of perennial allergic rhinitis of 2 years, with a documented positive allergen test to an appropriate allergen. * Female patients of child-bearing potential must be willing to consistently and correctly use an acceptable method of birth control.

Exclusion criteria

* Patients who require certain medications for their allergy. * Patients with serious medical problems.

Design outcomes

Primary

Measure	Time frame
Quantitative and qualitative differences in the morphology and cytology of the nasal mucosa after 1 year of treatment.	—

Secondary

Measure	Time frame
No Secondary Outcome Measures	—

Countries

Belgium, Netherlands

Outcome results

None listed

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