Study FFR116365, an Open-label Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis

• Clinical laboratory tests [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
  hematology and chemistry
• Mean change from baseline in 3TNSS (total nasal symptom score) [ Time Frame: the entire treatment period (12 weeks), Week 1-2, Week 3-4, Week 7-8 and Week 11-12 ] [ Designated as safety issue: No ]
  The 3 total nasal symptom score (3TNSS) is the sum of the 3 individual symptom scores for sneezing, rhinorrhea and nasal congestion where each symptom is scored on a scale of 0 to 3 (The maximum sum for a 3TNSS is 9). A subject's parent/guardian who signed ICF or a subject will score nasal symptoms everyday during the screening period and treatment period
• Mean change from baseline in 4TNSS [ Time Frame: the entire treatment period (12 weeks), Week 1-2, Week 3-4, Week 7-8 and Week 11-12 ] [ Designated as safety issue: No ]
  The 4 total nasal symptom score (4TNSS) is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion and nasal itching where each symptom is scored on a scale of 0 to 3 (The maximum sum for a 4TNSS is 12). A subject's parent/guardian who signed ICF or a subject will score nasal symptoms everyday during the screening period and treatment period.
• Mean change from baseline in each individual nasal symptom score; sneezing, rhinorrhea, nasal congestion and nasal itching [ Time Frame: the entire treatment period (12 weeks), Week 1-2, Week 3-4, Week 7-8 and Week 11-12 ] [ Designated as safety issue: No ]
  A subject's parent/guardian who signed ICF or a subject will score nasal symptoms everyday during the screening period and treatment period.
• Mean change from baseline in TOSS (total ocular symptom score) [ Time Frame: the entire treatment period (12 weeks), Week 1-2, Week 3-4, Week 7-8 and Week 11-12 ] [ Designated as safety issue: No ]
  The total ocular symptom score (TOSS) is the sum of the 3 individual symptom scores for eye itching, tearing and redness where each symptom is scored on a scale of 0 to 3 (The maximum sum for a TOSS is 9). A subject's parent/guardian who signed ICF or a subject will score ocular symptoms everyday during the screening period and treatment period.
• Mean change from baseline in score of troubles with daily life [ Time Frame: the entire treatment period (12 weeks), Week 1-2, Week 3-4, Week 7-8 and Week 11-12 ] [ Designated as safety issue: No ]
  A subject's parent/guardian who signed ICF or a subject will score the score of troubles with daily life everyday during the screening period and treatment period.
• Change from baseline in rhinoscopy findings [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Change from baseline in rhinoscopy findings (swelling of inferior turbinate mucosa, colour of inferior turbinate mucosa, quantity of nasal discharge and quality of nasal discharge).
• Overall evaluation of response to therapy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Subject's overall response to therapy (improvement in the symptoms of allergic rhinitis) compared with Visit 2

Safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 12 weeks in Japanese paediatric subjects ages 2 to < 15 years with perennial allergic rhinitis will be evaluated. And secondarily, efficacy and systemic exposure of GW685698X (55 µg/day, q.d.) nasal spray over a period of 12 weeks in Japanese paediatric subjects ages 2 to < 15 years with perennial allergic rhinitis will also be evaluated.

Inclusion Criteria:

• Informed Consent
• 2 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. Six months 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 >= 3.0 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.
• Bacterial or viral infection of upper respiratory tract or eye during the screening period.