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

• ClinicalTrials.gov Identifier: NCT00109486
• Recruitment Status: Completed
• First Posted: April 29, 2005
• Last Update Posted: September 15, 2016
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Tracking Information

• First Submitted Date: April 28, 2005
• First Posted Date: April 29, 2005
• Last Update Posted Date: September 15, 2016
• Study Start Date: April 2005
• Actual Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 4, 2006): 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.
• Original Primary Outcome Measures (submitted: June 23, 2005): 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.
• Current Secondary Outcome Measures (submitted: January 4, 2006): 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]).
• Original Secondary Outcome Measures (submitted: June 23, 2005): Frequency and type of clinical adverse events (AEs) experienced during treatment, nasal examinations, systolic and diastolic blood pressure, and heart rate.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Rhinitis, Allergic, Perennial and Seasonal
• Intervention: Drug: GW685698X

Study Arms

Experimental: Arm 1

Intervention: Drug: GW685698X

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 23, 2005): 56
• Original Enrollment: Same as current
• Actual Study Completion Date: November 2005
• Actual Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT00109486
• Other Study ID Numbers: FFR101747
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• 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.

• Current Responsible Party: GlaxoSmithKline
• Original Responsible Party: Not Provided
• Current Study Sponsor: GlaxoSmithKline
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: September 2016