Clinical trial NCT01630135: Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis
Official title: Study FFR116364, a Double-blind, Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 261
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period
timeFrame: Baseline through the entire treatment period (2 weeks)
Secondary outcomes:
measure: Mean Change From Baseline in 3TNSS at Week 1 and Week 2
timeFrame: Baseline; Week 1 and Week 2
measure: Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2
timeFrame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
measure: Mean Change From Baseline in 3TNSS at the Indicated Days
timeFrame: Baseline; Days 1 through 14
measure: Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2
timeFrame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
measure: Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2
timeFrame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
measure: Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2
timeFrame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
measure: Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2
timeFrame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
measure: Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2
timeFrame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
measure: Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2
timeFrame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
measure: Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2
timeFrame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
measure: Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2
timeFrame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
measure: Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2
timeFrame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
measure: Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW
timeFrame: Baseline, Week 1, and Week 2/Early Withdrawal (EW)
measure: Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator
timeFrame: Week 2/EW
measure: Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant
timeFrame: Week 2/EW
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Gifu
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Saitama
country: Japan
facility: GSK Investigational Site
city: Saitama
country: Japan
facility: GSK Investigational Site
city: Saitama
country: Japan
facility: GSK Investigational Site
city: Saitama
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: