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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2005-11-30

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.

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Detailed Description

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Conditions

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Rhinitis, Allergic, Perennial and Seasonal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

GW685698X

Intervention Type DRUG

Interventions

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GW685698X

Intervention Type DRUG

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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Randers, , Denmark

Site Status

Countries

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Denmark

Study Documents

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