Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis

Study FFR116364, a Double-blind, Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis

Efficacy and safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 2 weeks in Japanese paediatric subjects ages 6 to < 15 years with perennial allergic rhinitis will be evaluated compared with placebo.

Inclusion Criteria:

• Informed Consent
• 6 to <15 years of age, male or eligible female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control), outpatient
• Diagnosis of perennial allergic rhinitis: A positive test response to house dust and/or dust mites on serum antigen-specific IgE antibody test at Visit 1. One year or more clinical history of perennial allergic rhinitis. A positive test result on nasal eosinophil count at Visit 1/1A.
• Either subject's parent/guardian who signed ICF or subject is able to complete assessments on the patient diary through the study.
• ALT < 2xULN; alkaline phosphatase and bilirubin <= 1.5xULN
• Average of 3TNSS is >= 4.0 in the last consecutive 4 days prior to Visit 2.
• Completion of the patient diary on >= 3 days of the last consecutive 4 days prior to Visit 2

Exclusion Criteria:

• Has a seasonal pollen as an allergen
• A nose disorder that could affect the assessment of the study medication or eye or nose surgery (within 3 months prior to Visit 1)
• Bacterial or viral infection of upper respiratory tract or eye
• Concurrent disease/abnormalities: Clinically significant uncontrolled disease
• Known hypersensitivity to corticosteroids or any excipients in the investigational product
• Has recent participation in a study and/or exposure to an investigational study drug within 3 months prior to Visit 1
• Use of the following medication and/or its combination drug within the specified time:

Anti-IgE (Within 6 months prior to Visit 1), Immunosuppressive medications or Systemic corticosteroids (Within 8 weeks prior to Visit 1), Topical corticosteroids (Within 4 weeks prior to Visit 1), Immunotherapy or nonspecific allassotherapy which was initiated, discontinued or changed its dose within 4 weeks prior to Visit 1

• Affiliation with Investigator's Site: Relative or employee
• History of alcohol or drug abuse, children in care or in the opinion of the investigator (sub-investigator), inappropriate to be enrolled in the study.
• Average of 3TNSS is >= 8.0 in the last consecutive 4 days prior to Visit 2.
• Bacterial or viral infection of upper respiratory tract or eye during the screening period.