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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rhinitis, Allergic, Perennial and Seasonal	Drug: GW685698X	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, 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
• Study Start Date: April 2005
• Actual Primary Completion Date: November 2005
• Actual Study Completion Date: November 2005

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1	Drug: GW685698X

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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]).

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• 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

Locations

Denmark

GSK Investigational Site

Randers, Denmark, 8900

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Dataset Specification 

Identifier: FFR101747
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: FFR101747
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: FFR101747
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: FFR101747
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: FFR101747
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: FFR101747
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: FFR101747
For additional information about this study please refer to the GSK Clinical Study Register

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00109486
• Other Study ID Numbers: FFR101747
• First Posted: April 29, 2005
• Last Update Posted: September 15, 2016
• Last Verified: September 2016

Individual Participant Data (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.

Keywords provided by GlaxoSmithKline:

GW685698X; seasonal allergic rhinitis; perennial allergic rhinitis; knemometry; children

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases