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

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

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.