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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Rhinitis, Allergic, Perennial

Treatments

Drug: Placebo

Drug: Fluticasone furoate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01630135

116364

Details and patient eligibility

About

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.

Enrollment

261 patients

Sex

All

Ages

6 to 14 years old

Volunteers

No Healthy Volunteers

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.