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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rhinitis, Allergic, Perennial and Seasonal

Intervention / Treatment
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* Drug: GW685698X


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: GW685698X<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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]). |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GW685698X, seasonal allergic rhinitis, perennial allergic rhinitis, knemometry, children