Clinical trial NCT00109486: 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
Official title: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial and Seasonal
Keywords: GW685698X
seasonal allergic rhinitis
perennial allergic rhinitis
knemometry
children
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-04-29
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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 outcomes:
measure: 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]).
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: