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.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00109486
First received: April 28, 2005
Last updated: October 15, 2008
Last verified: October 2008
  Purpose

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
  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109486

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

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov 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:
knemometry
GW685698X
seasonal allergic rhinitis
perennial allergic rhinitis
children

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014