Study In Adults And Adolescents With Seasonal Allergic Rhinitis

Completed · Phase 3

Conditions studied: Hayfever, Rhinitis, Allergic, Seasonal, Seasonal Allergic Rhinitis

In brief

The purpose of the study is to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray 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. Commonly referred to as "hay fever", it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.

Key facts

Study ID

NCT00115622

Run by

GlaxoSmithKline

People needed

304

Starts

2004-12-01

Expected to finish

2005-01-01

Last updated by the study team

2016-09-01

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.
• Adequate exposure to allergen.
• 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 the investigational product.

Where it is running

• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — New Braunfels, Texas, United States
• GSK Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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