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

NCT00109486 | Completed Phase 3

• 1 other identifier: FFR101747
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinitis, Allergic, Perennial and Seasonal

Keywords

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

Outcome Measures

Primary Outcomes (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 Outcomes (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]).

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: GW685698X

Interventions

GW685698X DRUG

Arm 1

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Randers, 8900, Denmark

Location

Related Links

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

MeSH Terms

Conditions

Rhinitis; Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2005
• First Posted: April 29, 2005
• Study Start: April 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: September 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)