Study In Adolescent And Adult Subjects 12 Years Of Age And Older With Seasonal Allergic Rhinitis To Assess Onset of Action

Completed · Phase 3

Conditions studied: Rhinitis, Allergic, Seasonal

In brief

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. Commonly referred to as "hay fever", it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes. The purpose of this study is to evaluate the onset of action of an investigational nasal spray, GW685698X aqueous nasal spray, versus vehicle placebo nasal spray in the treatment of seasonal allergic rhinitis caused by ragweed following a single dose of treatment in controlled pollen concentrations in an allergen challenge chamber.

Key facts

Study ID

NCT00118729

Run by

GlaxoSmithKline

People needed

380

Starts

2005-04-01

Expected to finish

2005-08-01

Last updated by the study team

2016-09-15

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent
• Outpatient
• Females must use appropriate contraception
• Diagnosis of seasonal allergic rhinitis
• Able to comply with study procedures
• Literate

You may not qualify if…

• Significant concomitant medical condition
• Use of corticosteroids, allergy medications, or tobacco
• Clinically significant abnormal ECG
• Laboratory abnormality
• Positive pregnancy test
• Allergy to any component of investigational product

Where it is running

• GSK Investigational Site — Woodstock, Georgia, United States

Full record on ClinicalTrials.gov

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