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

Rhinitis, Allergic, Perennial and Seasonal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109486
• Other study ID #: FFR101747
• Status: Completed
• Phase: Phase 3
• First received: April 28, 2005
• Last updated: September 13, 2016
• Start date: April 2005
• Est. completion date: November 2005

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial
• Rhinitis, Allergic, Perennial and Seasonal

Intervention

Drug:
• GW685698X

Locations

Country	Name	City	State
Denmark	GSK Investigational Site	Randers

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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]).

External Links

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