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

A Randomised, Double-Blind, Placebo-Controlled, Two-Week Crossover, Knemometric Assessment of the Effect of Fluticasone Furoate Nasal Spray 100mcg Once Daily on Short-Term Growth in Children Aged 6 to 11 Years With Seasonal and/or Perennial Allergic Rhinitis

The purpose of this study is to assess any effect in children with seasonal and/or perennial allergic rhinitis by GW685698X aqueous nasal spray (versus vehicle placebo nasal spray) on growth using knemometry.

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.