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

NCT01622231 | Completed Phase 3 Results

• 1 other identifier: 116365
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Rhinitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)

  An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an other important medical event, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold \>=5%) and SAEs.

  From the start of study treatment (Visit 2) until follow-up contact (Visit 6) (up to 13 weeks)

Secondary Outcomes (24)

• Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal

  Baseline, Week 4, and Week 12/Early Withdrawal

• Change From Baseline in Hemoglobin at Week 4 and Week 12/Early Withdrawal

  Baseline, Week 4, and Week 12/Early Withdrawal

• Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Week 4 and Week 12/Early Withdrawal

  Baseline, Week 4, and Week 12/Early Withdrawal

• Change From Baseline in Red Blood Cell (RBC) Count at Week 4 and Week 12/Early Withdrawal

  Baseline, Week 4, and Week 12/Early Withdrawal

• Change From Baseline in Hematocrit at Week 4 and Week 12/Early Withdrawal

  Baseline, Week 4, and Week 12/Early Withdrawal

Study Arms (1)

GW685698X

EXPERIMENTAL

GW685698X 55mcg/day

Drug: Fluticasone furoate

Interventions

Fluticasone furoate DRUG

55 mcg/day, intranasal, 12 weeks

GW685698X

Eligibility Criteria

• Age: 2 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. 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

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.
• Bacterial or viral infection of upper respiratory tract or eye during the screening period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Chiba, 272-0143, Japan

Location

GSK Investigational Site

Chiba, 277-0882, Japan

Location

GSK Investigational Site

Gifu, 501-3247, Japan

Location

GSK Investigational Site

Saitama, 355-0062, Japan

Location

GSK Investigational Site

Tokyo, 160-0017, Japan

Location

GSK Investigational Site

Tokyo, 170-0005, 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

Interventions

fluticasone furoate

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2012
• First Posted: June 19, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 9, 2017
• Results First Posted: August 12, 2013

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

JP (6)