Long Term Safety Of GW685698X Via Nasal Biopsy

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Rhinitis, Allergic, Perennial

Treatments: Drug: mometasone furoate; Drug: GW685698X

Study type: Interventional

Funder types: Industry

Identifiers

NCT00224523

FFR104503

Details and patient eligibility

About

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.

Full 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)

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: mometasone furoate

Drug: GW685698X