Study of GW685698X In Patients With Seasonal Allergic Rhinitis

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Rhinitis, Allergic, Seasonal

Treatments: Drug: GW685698X Aqueous Nasal Spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT00363740

FFR100652

Details and patient eligibility

About

This study was designed to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray and commonly used drug in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Typical symptoms are sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.

Enrollment: 38 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent
• Outpatient
• Diagnosis of seasonal allergic rhinitis with symptoms
• Able to comply with study procedures

Exclusion criteria

• Significant concomitant medical condition
• Use of corticosteroids/allergy medications
• Laboratory abnormality
• Positive pregnancy test
• Allergy to any component of investigational product

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind