A randomized, double-blind, placebo-controlled, 2-week crossover, knemometricassessment of the effect of once daily GW685698X Aqueous Nasal Spray 100 mcgon short term growth in children ages 6 - 11 years with seasonal and/or perennialallergic rhinitis

Phase 1

• Conditions: Seasonal and/or perennial allergic rhinitis

• Registration Number: EUCTR2004-004749-17-DK
• Lead Sponsor: GlaxoSmithKline Research & Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-10
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

A subject will be eligible for inclusion in this study only if all of the following criteria
apply:

• Pre-menarcheal female subjects who are 6 years to less than 11 years of age at
the time of randomization
• Male subjects who are 6 years to less than 12 years of age at the time of
randomization
• Tanner Stage 1
• Documented clinical history of SAR or PAR of at least one year prior to study entry
with (in the opinion of the investigator):
- a current level of allergic rhinitis symptoms that warrant treatment with an
intranasal corticosteroid and/or
- expected symptoms during a majority of the study period
Diagnosis must be confirmed by a positive skin test (by skin prick method) to an
appropriate seasonal or perennial allergen within 12 months prior to Visit 1 or at
Visit 1. A positive skin test is defined as a wheal > or equal to 3 mm larger than
the diluent control for prick testing.
In vitro tests for specific IgE (such as RAST, PRIST) will also be permitted as
confirmation for a diagnosis of SAR or PAR if performed within the last 12 months
or at Visit 1.
• Normal current growth as reflected by baseline height within the 5th and 95th
percentiles of normal for their age and gender as determined by stadiometry and
Danish longitudinal standard charts
• Subjects must be willing and able to comply with study procedures
• Written informed consent must be provided by the parent or guardian
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A subject will not be eligible for inclusion in this study if any of the following criteria
apply:
• History of abnormal growth or gross malnutrition
• Findings of a clinically significant laboratory abnormality (Section 6.4.4)
• History of any condition that may have substantially affected growth
• Subjects with historical or current evidence of clinically significant, uncontrolled
disease of any body system (in addition to allergic rhinitis), such as uncontrolled,
epilepsy, active tuberculosis, attention deficit hyperactive disorder, psychological
disorders or eczema, will not be eligible. Significant is defined as any disease that,
in the opinion of the investigator, would put the safety of the subject at risk
through study participation or which would confound the interpretation of the
study results if the disease/condition exacerbated during the study
• Any asthma other than mild, intermittent asthma controlled by short-acting, ß-
agonists [Global Initiative for Asthma (GINA) Guidelines, 2003]
• Recent major surgery and/or trauma to the legs
• Current or history of glaucoma and/or cataracts or ocular herpes simplex
• 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, defined as Any corticosteroid use by any route within 4
weeks prior to Visit 1
• Any nasal condition or deformity that would impair nasal breathing or deposition of
medication (i.e., nasal polyps, marked septal deviation)
• Physical impairment that would affect the subject’s ability to participate in the study
• Documented evidence of acute or significant chronic sinusitis
• Upper or lower respiratory or sinus infection during the 7 days before screening
• Clinical evidence of a nasal or oropharyngeal Candida infection
• Rhinitis medicamentosa
• Severe dehydration
• Use of any medications that significantly inhibit the cytochrome P450 subfamily
enzyme CYP3A4, including ritonavir and ketoconazole
• Subjects with known hypersensitivity to any excipients in the study medications
• Previous clinical trial experience with GW685698X aqueous nasal spray
• Exposure to clinical trial/experimental medication within 30 days of Visit 1
• Affiliation with investigational site such that the subject is an immediate family
member of any site personnel
• Chickenpox or measles infections - A subject is not eligible if he/she currently has
chickenpox or measles, or has been exposed to chickenpox or measles during the
last 3 weeks and is non-immune.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to determine the effect on lower leg growth of<br>treatment with 100 mcg of intranasal GW685698X aqueous nasal spray QD versus<br>placebo nasal spray QD in children ages 6 to 11 years with seasonal allergic rhinitis<br>(SAR) and/or perennial allergic rhinitis (PAR).<br>;Secondary Objective: None;Primary end point(s): The primary safety endpoint will be the mean growth velocity (mm/wk) in lower leg<br>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.