Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Fluticasone furoate; Placebo
Intervention description: 55 mcg/day, intranasal, 2 weeks; Placebo, intranasal, 2 weeks
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 261.0
Sex: All
Minimum age: 6 Years
Maximum age: 14 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.