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

Purpose

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.

Condition	Intervention	Phase
Rhinitis	Drug: Fluticasone furoate	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Study FFR116365, an Open-label Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis

Resource links provided by NLM:

Drug Information available for: Fluticasone propionate Fluticasone Fluticasone furoate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Frequency and severity of clinical adverse events [ Time Frame: from the start of study treatment and until the follow up contact (13 weeks) ] [ Designated as safety issue: No ]
AEs will be collected from the start of study treatment (Visit 2) and until the follow up contact (Visit 6). SAEs will be collected over the same time period as stated above for AEs. However, any SAEs assessed as related to study participation (e.g., study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK concomitant medication, will be recorded from the time a subject consents to participate in the study up to and including any follow up contact.

Secondary Outcome Measures:

Clinical laboratory tests [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
hematology and chemistry
Mean change from baseline in 3TNSS (total nasal symptom score) [ Time Frame: the entire treatment period (12 weeks), Week 1-2, Week 3-4, Week 7-8 and Week 11-12 ] [ Designated as safety issue: No ]
The 3 total nasal symptom score (3TNSS) is the sum of the 3 individual symptom scores for sneezing, rhinorrhea and nasal congestion where each symptom is scored on a scale of 0 to 3 (The maximum sum for a 3TNSS is 9). A subject's parent/guardian who signed ICF or a subject will score nasal symptoms everyday during the screening period and treatment period
Mean change from baseline in 4TNSS [ Time Frame: the entire treatment period (12 weeks), Week 1-2, Week 3-4, Week 7-8 and Week 11-12 ] [ Designated as safety issue: No ]
The 4 total nasal symptom score (4TNSS) is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion and nasal itching where each symptom is scored on a scale of 0 to 3 (The maximum sum for a 4TNSS is 12). A subject's parent/guardian who signed ICF or a subject will score nasal symptoms everyday during the screening period and treatment period.
Mean change from baseline in each individual nasal symptom score; sneezing, rhinorrhea, nasal congestion and nasal itching [ Time Frame: the entire treatment period (12 weeks), Week 1-2, Week 3-4, Week 7-8 and Week 11-12 ] [ Designated as safety issue: No ]
A subject's parent/guardian who signed ICF or a subject will score nasal symptoms everyday during the screening period and treatment period.
Mean change from baseline in TOSS (total ocular symptom score) [ Time Frame: the entire treatment period (12 weeks), Week 1-2, Week 3-4, Week 7-8 and Week 11-12 ] [ Designated as safety issue: No ]
The total ocular symptom score (TOSS) is the sum of the 3 individual symptom scores for eye itching, tearing and redness where each symptom is scored on a scale of 0 to 3 (The maximum sum for a TOSS is 9). A subject's parent/guardian who signed ICF or a subject will score ocular symptoms everyday during the screening period and treatment period.
Mean change from baseline in score of troubles with daily life [ Time Frame: the entire treatment period (12 weeks), Week 1-2, Week 3-4, Week 7-8 and Week 11-12 ] [ Designated as safety issue: No ]
A subject's parent/guardian who signed ICF or a subject will score the score of troubles with daily life everyday during the screening period and treatment period.
Change from baseline in rhinoscopy findings [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in rhinoscopy findings (swelling of inferior turbinate mucosa, colour of inferior turbinate mucosa, quantity of nasal discharge and quality of nasal discharge).
Overall evaluation of response to therapy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Subject's overall response to therapy (improvement in the symptoms of allergic rhinitis) compared with Visit 2

Enrollment:	61
Study Start Date:	June 2012
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: GW685698X GW685698X 55mcg/day	Drug: Fluticasone furoate 55 mcg/day, intranasal, 12 weeks

Eligibility

Ages Eligible for Study:	2 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622231

Locations

Japan
GSK Investigational Site
Chiba, Japan, 272-0143
GSK Investigational Site
Chiba, Japan, 277-0882
GSK Investigational Site
Gifu, Japan, 501-3247
GSK Investigational Site
Saitama, Japan, 355-0062
GSK Investigational Site
Tokyo, Japan, 160-0017
GSK Investigational Site
Tokyo, Japan, 170-0005

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01622231 History of Changes
Other Study ID Numbers:	116365
Study First Received:	June 7, 2012
Last Updated:	November 28, 2012
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone

Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013