Overview

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.