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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: April 28, 2005
Last updated: October 15, 2008
Last verified: October 2008

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.

Condition Intervention Phase
Seasonal Allergic Rhinitis
Perennial Allergic Rhinitis
Drug: GW685698X
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, 2-Week Crossover, Knemometric Assessment of the Effect of Once Daily GW685698X Aqueous Nasal Spray 100 Mcg on Short Term Growth in Children Ages 6 - 11 Years With Seasonal and/or Perennial Allergic Rhinitis

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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]).

Estimated Enrollment: 56
Study Start Date: April 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW685698X
    Other Name: GW685698X

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
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:

  • 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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00109486

GSK Investigational Site
Randers, Denmark, 8900
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK Identifier: NCT00109486     History of Changes
Other Study ID Numbers: FFR101747
Study First Received: April 28, 2005
Last Updated: October 15, 2008
Health Authority: United States: Food and Drug Administration
Denmark: Danish Medicines Agency

Keywords provided by GlaxoSmithKline:
seasonal allergic rhinitis
perennial allergic rhinitis

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Immune System Diseases
Respiratory Tract Infections processed this record on April 17, 2014