Safety Study To Assess Growth In Children With Seasonal Allergic And/Or Perennial Allergic Rhinitis Treated With GW685698X Aqueous Nasal Spray Or Placebo Nasal Spray
Rhinitis, Allergic, Perennial and Seasonal
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Perennial and Seasonal focused on measuring GW685698X, seasonal allergic rhinitis, perennial allergic rhinitis, knemometry, children
Eligibility Criteria
Inclusion criteria: Females (ages 6 to 11) who have not begun menses. Males (ages 6 to 12). Tanner Stage 1. History of SAR (Seasonal Allergic Rhinitis) or PAR (Perennial Allergic Rhinitis) of at least one year with either a current level of allergic rhinitis symptoms that warrants treatment and/or expected symptoms during a majority of the study period. Positive skin test to an appropriate seasonal or perennial allergen. Exclusion criteria: History of abnormal growth or gross malnutrition. Clinically significant laboratory abnormality. History of any condition that may have substantially affected growth. Historical or current evidence of clinically significant, uncontrolled disease of any body system. Any asthma other than mild, intermittent asthma controlled by short-acting, beta-agonists. Recent major surgery and/or trauma to the legs. History of adrenal insufficiency. Current or prior treatment with any medication that may have a potential for an ongoing effect on linear growth. Use of corticosteroids, by any route, within 4 weeks prior to Visit 1. Any nasal condition or deformity that would impair nasal breathing or deposition of medication. Physical impairment that would affect the subject's ability to participate in the study.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Experimental
Arm 1