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Protocol Summary for 116364

Protocol Summary
Protocol Id:	116364
Secondary Ids:
Title:	Study FFR116364, a double-blind, placebo-controlled study of GW685698X in paediatric subjects with perennial allergic rhinitis
Phase:	phase 3
Acronym:
FDA Regulated Intervention?:	Yes
Section 801 Clinical Trial?:	Yes
Delayed Posting:	No
IND/IDE Protocol?:	no
Study Type:	Interventional
Oversight Authority:	Japan: Pharmaceuticals and Medical Devices Agency
Collaborators:
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.
Detailed Description:
Record Verification Date:	September 2012
Status:	Completed
Why Study Stopped:
Study Start Date:	June 2012
Study Completion Date:	August 2012
Study Completion Date Type:	Actual
Primary Completion Date:	August 2012
Primary Completion Date Type:	Actual
Primary Purpose:	treatment
Allocation:	Randomized
Masking:	Double Blind
Masked Subject:	yes
Masked Caregiver:	yes
Masked Investigator:	yes
Masked Assessor:	yes
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Efficacy Study
Primary Outcomes:	Mean change from Baseline in the 3 Total Nasal Symptom Score (3TNSS) over the entire treatment period Baseline through the entire treatment period (2 weeks)
Secondary Outcomes:	Number of participants with the indicated overall response to therapy, as assessed by the investigator Week 2/EW Mean change from Baseline in 3TNSS at the indicated days Baseline; Days 1 through 14 Mean change from Baseline in the score of troubles with daily life 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 rhinorrhea, nasal congestion, sneezing, and nasal itching over the entire treatment period (ETP), 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 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 Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 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 Baseline, Week 1, and Week 2/Early Withdrawal (EW) Number of participants with the indicated overall response to therapy, as assessed by the participant’s parent/guardian or the participant Week 2/EW 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 Baseline through the entire treatment period (2 weeks), 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 percent change from Baseline (BL) in the TOSS 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 Week 1 and Week 2 Baseline; Week 1 and Week 2 Mean change from Baseline in the total ocular symptom score (TOSS) 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 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 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 Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
Conditions:	Rhinitis
Keywords:
Eligibility Criteria:	Click to view inclusion/exclusion 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.
Gender:	Both
Minimum Age:	6 Year
Maximum Age:	14 Year
Enrollment:	261
Enrollment Type:	Actual
Healthy Volunteers?:	none
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information Japan (click to view all sites in Japan) GSK Investigational Site Tokyo, 125-0052; COMPLETED; Contact: Ichiro Ogiwara, Principal Investigator, . GSK Investigational Site Saitama, 355-0062; COMPLETED; Contact: Kanji Baba, Principal Investigator, . GSK Investigational Site Hokkaido, 062-0034; COMPLETED; Contact: Mizuho Goto, Principal Investigator, . GSK Investigational Site Kanagawa, 222-0011; COMPLETED; Contact: Seiji Sawaki, Principal Investigator, . GSK Investigational Site Tokyo, 151-0072; COMPLETED; Contact: Sadamu Minami, Principal Investigator, . GSK Investigational Site Chiba, 279-0012; COMPLETED; Contact: Nobuyuki Komatsu, Principal Investigator, . GSK Investigational Site Kanagawa, 232-0056; COMPLETED; Contact: Hideto Kitagoh, Principal Investigator, . GSK Investigational Site Tokyo, 170-0005; COMPLETED; Contact: Shinichi Okura, Principal Investigator, . GSK Investigational Site Chiba, 261-0004; COMPLETED; Contact: Rinya Sugita, Principal Investigator, . GSK Investigational Site Tokyo, 160-0017; COMPLETED; Contact: Shoji Matsune, Principal Investigator, . GSK Investigational Site Tokyo, 178-0064; COMPLETED; Contact: Keisuke Uesugi, Principal Investigator, . GSK Investigational Site Saitama, 350-1205; COMPLETED; Contact: Fumio Dohi, Principal Investigator, . GSK Investigational Site Chiba, 270-0034; COMPLETED; Contact: Masaki Kato, Principal Investigator, . GSK Investigational Site Hokkaido, 061-1133; COMPLETED; Contact: Masato Hata, Principal Investigator, . GSK Investigational Site Saitama, 354-0018; COMPLETED; Contact: Tetsuo Takeda, Principal Investigator, . GSK Investigational Site Tokyo, 114-0023; COMPLETED; Contact: Fumio Sakaguchi, Principal Investigator, . GSK Investigational Site Chiba, 272-0143; COMPLETED; Contact: Yutaka Fujimaki, Principal Investigator, . GSK Investigational Site Saitama, 333-0861; COMPLETED; Contact: Emiko Shiba, Principal Investigator, . GSK Investigational Site Gifu, 501-3247; COMPLETED; Contact: Shigenori Matsubara, Principal Investigator, . GSK Investigational Site Chiba, 277-0882; COMPLETED; Contact: Yasuko Murakawa, Principal Investigator, . GSK Investigational Site Kanagawa, 222-0031; COMPLETED; Contact: Hitoshi Miho, Principal Investigator, . GSK Investigational Site Hokkaido, 001-0923; COMPLETED; Contact: Masaki Yokohama, Principal Investigator, .

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Protocol Summary for 116364