Rhinitis, Allergic, Perennial and Seasonal
Conditions
Keywords
GW685698X, seasonal allergic rhinitis, perennial allergic rhinitis, knemometry, children
Brief 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.
Interventions
DRUGGW685698X
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint will be the mean growth velocity (mm/wk) in lower leg growth, as determined by knemometry, over a 2-week treatment period with intranasal GW685698X aqueous nasal spray versus a 2-week treatment with placebo nasal spray. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will include the frequency and type of clinical adverse events (AEs) experienced during treatment, nasal examinations, vital signs (systolic and diastolic blood pressure, heart rate [pulse]). | — |
Countries
Denmark
Outcome results
None listed