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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Rhinitis, Allergic, Perennial and Seasonal

Treatments

Drug: GW685698X

Study type

Interventional

Funder types

Industry

Identifiers

NCT00109486

FFR101747

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

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.