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.
Full Title of Study: “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”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: November 2005
- Drug: GW685698X
Arms, Groups and Cohorts
- Experimental: Arm 1
Clinical Trial Outcome Measures
- 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 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]).
Participating in This Clinical Trial
- 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.
- 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.
Gender Eligibility: All
Minimum Age: 6 Years
Maximum Age: 12 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Provider of Information About this Clinical Study
- Overall Official(s)
- GSK Clinical Trials, Study Director, GlaxoSmithKline
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