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CompletedNCT00109486Updated Sep 15, 2016

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

A Phase 3 interventional study of GW685698X in Rhinitis, Allergic, Perennial and Seasonal, sponsored by GlaxoSmithKline. Completed at 1 site in Denmark. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2016-09-15.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Rhinitis, Allergic, Perennial and Seasonal

Keywords

  • GW685698X
  • seasonal allergic rhinitis
  • perennial allergic rhinitis
  • knemometry
  • children
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 56 is below the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: GW685698X

Interventions

  • DrugGW685698X
06

What researchers measure

Primary outcomes

  1. 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

  1. 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]).

07

Study locations

1 site
  • GSK Investigational Site
    Randers, 8900, Denmark
08

References and documents

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00109486
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Apr 29, 2005
Start date
Apr 2005
Primary completion
Nov 2005
Completion
Nov 2005
Last update
Sep 15, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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