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

NCT01630135 | Completed Phase 3 Results

• 1 other identifier: 116364
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 22

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.

Conditions

Rhinitis, Allergic, Perennial

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period

  The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score for the entire treatment period minus the score at Baseline.

  Baseline through the entire treatment period (2 weeks)

Secondary Outcomes (15)

• Mean Change From Baseline in 3TNSS at Week 1 and Week 2

  Baseline; Week 1 and Week 2

• Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2

  Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

• Mean Change From Baseline in 3TNSS at the Indicated Days

  Baseline; Days 1 through 14

• Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2

  Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

• Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2

  Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

Study Arms (2)

GW685698X

EXPERIMENTAL

GW685698X 55mcg/day

Drug: Fluticasone furoate

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Fluticasone furoate DRUG

55 mcg/day, intranasal, 2 weeks

GW685698X

Placebo DRUG

Placebo, intranasal, 2 weeks

Placebo

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Informed Consent
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (22)

GSK Investigational Site

Chiba, 261-0004, Japan

Location

GSK Investigational Site

Chiba, 270-0034, Japan

Location

GSK Investigational Site

Chiba, 272-0143, Japan

Location

GSK Investigational Site

Chiba, 277-0882, Japan

Location

GSK Investigational Site

Chiba, 279-0012, Japan

Location

GSK Investigational Site

Gifu, 501-3247, Japan

Location

GSK Investigational Site

Hokkaido, 001-0923, Japan

Location

GSK Investigational Site

Hokkaido, 061-1133, Japan

Location

GSK Investigational Site

Hokkaido, 062-0034, Japan

Location

GSK Investigational Site

Kanagawa, 222-0011, Japan

Location

GSK Investigational Site

Kanagawa, 222-0031, Japan

Location

GSK Investigational Site

Kanagawa, 232-0056, Japan

Location

GSK Investigational Site

Saitama, 333-0861, Japan

Location

GSK Investigational Site

Saitama, 350-1205, Japan

Location

GSK Investigational Site

Saitama, 354-0018, Japan

Location

GSK Investigational Site

Saitama, 355-0062, Japan

Location

GSK Investigational Site

Tokyo, 114-0023, Japan

Location

GSK Investigational Site

Tokyo, 125-0052, Japan

Location

GSK Investigational Site

Tokyo, 151-0072, Japan

Location

GSK Investigational Site

Tokyo, 160-0017, Japan

Location

GSK Investigational Site

Tokyo, 170-0005, Japan

Location

GSK Investigational Site

Tokyo, 178-0064, Japan

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

fluticasone furoate

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 11, 2017
• Results First Posted: May 1, 2013

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

JP (22)