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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 (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00109486
First received: April 28, 2005
Last updated: September 13, 2016
Last verified: September 2016
  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
Rhinitis, Allergic, Perennial and Seasonal
Drug: GW685698X
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Placebo-Controlled, Two-Week Crossover, Knemometric Assessment of the Effect of Fluticasone Furoate Nasal Spray 100mcg Once Daily on Short-Term Growth in Children Aged 6 to 11 Years With Seasonal and/or Perennial Allergic Rhinitis

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]).

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)
Arms Assigned Interventions
Experimental: Arm 1 Drug: GW685698X

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years   (Child)
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 GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: FFR101747
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: FFR101747
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: FFR101747
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: FFR101747
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: FFR101747
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: FFR101747
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: FFR101747
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00109486     History of Changes
Other Study ID Numbers: FFR101747 
Study First Received: April 28, 2005
Last Updated: September 13, 2016
Health Authority: Denmark: Danish Medicines Agency
United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
GW685698X
seasonal allergic rhinitis
perennial allergic rhinitis
knemometry
children

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

ClinicalTrials.gov processed this record on December 02, 2016