Last updated: 11/07/2018 10:23:42

Study FFR116365, an open-label study of GW685698X in paediatric subjects with perennial allergic rhinitis

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GSK study ID
116365
See study documents
Clinicaltrials.gov ID
NCT01622231
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Study FFR116365, an open-label study of GW685698X in paediatric subjects with perennial allergic rhinitis
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of participants with any non-serious adverse event (AE) and any serious adverse event (SAE)

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

Secondary outcomes:

Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, and total neutrophil count at Week 4 and Week 12/Early Withdrawal

Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal

Change from Baseline in hemoglobin at Week 4 and Week 12/Early Withdrawal

Timeframe: 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

Timeframe: 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

Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal

Change from Baseline in hematocrit at Week 4 and Week 12/Early Withdrawal

Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal

Change from Baseline in albumin and total protein at Week 4 and Week 12/Early Withdrawal

Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal

Change from Baseline in alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal

Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal

Change from Baseline in direct bilirubin, total bilirubin, and creatinine at Week 4 and Week 12/Early Withdrawal

Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal

Change from Baseline in calcium, chloride, potassium, sodium, and urea/blood urea nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal

Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal

Mean change from Baseline in the 3 Total Nasal Symptom Score (3TNSS) over the entire treatment period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Mean percent change from Baseline in the 3 Total Nasal Symptom Score (3TNSS) over the entire treatment period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Mean change from Baseline (BL) in daily variation of the 3 Total Nasal Symptom Score (3TNSS)

Timeframe: Baseline, Day 1 to Day 84

Mean change from Baseline in the 4 Total Nasal Symptom Score (4TNSS) over the entire treatment period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Mean percent change from Baseline in the 4 Total Nasal Symptom Score (4TNSS) over the entire treatment period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Mean change from Baseline in the total ocular symptom score (TOSS) over the entire treatment period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Mean percent change from Baseline in the total ocular symptom score (TOSS) over the entire treatment period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Mean change from Baseline in sneezing, rhinorrhea, nasal congestion, and nasal itching over the entire treatment period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Mean change from Baseline in eye itching, tearing, and redness over the entire treatment period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Mean change from Baseline in the score of troubles with daily life over the entire treatment period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

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)

Timeframe: Baseline, Week 4, Week 8, and Week 12/early withdrawal

Number of participants with the indicated overall response to therapy, as assessed by the investigator

Timeframe: Week 12/early withdrawal

Number of participants with the indicated overall response to therapy, as assessed by the participant’s parent/guardian or the participant

Timeframe: Week 12/early withdrawal

Number of participants with the indicated plasma concentration of GW685698X for participants aged >=2 to <6 years

Timeframe: Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5)

Number of participants with the indicated plasma concentration of GW685698X for participants aged >=6 to <15 years

Timeframe: Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5)

Interventions:
  • Drug: Fluticasone furoate
    • Enrollment:
    61
    Primary completion date:
    2012-05-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    K Okubo, A Okamasa, G Honma, M Komatsubara.Safety and efficacy of fluticasone furoate nasal spray in Japanese children 2 to <15 years of age with perennial allergic rhinitis: a multicentre, open-label trial.Allergol Int.2014;doi: 10.2332/allergolint.14-OA-0688
    Medical condition
    Rhinitis
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    June 2012 to November 2012
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    2 - 14 years
    Accepts healthy volunteers
    No
    • 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
    • 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)
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Chiba, Japan, 277-0882
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Saitama, Japan, 355-0062
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chiba, Japan, 272-0143
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tokyo, Japan, 170-0005
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tokyo, Japan, 160-0017
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Gifu, Japan, 501-3247
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2012-05-11
    Actual study completion date
    2012-05-11

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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