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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Xhance

Criteria

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.