A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD
A Long-term Study to Evaluate the Safety and Tolerability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Japanese Subjects With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
187
1 country
35
Brief Summary
The primary purpose of the study is to evaluate the safety and tolerability of fluticasone furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese patients with COPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2010
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 30, 2010
CompletedFirst Posted
Study publicly available on registry
August 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
August 12, 2013
CompletedJanuary 11, 2017
November 1, 2016
1.4 years
August 30, 2010
June 6, 2013
November 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period
An AE is defined as any untoward medical occurrence in a participant or clinical investigation 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, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, 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 investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Number of Participants With Any Drug-related AE and Any Drug-related SAE Throughout the Treatment Period
An AE is defined as any untoward medical occurrence in a participant or clinical investigation 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, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Relatedness was assessed by the investigator.
From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Secondary Outcomes (8)
Number of Participants With Pneumonia During the Treatment Period
From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)
Baseline (Week -2), and Week 52/Withdrawal (WD)
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)
Baseline (Week -2), and Week 52/Withdrawal (WD
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD)
Baseline (Week -2), Week 52/Withdrawal (WD)
Change From Baseline in 24-hour Urinary Cortisol Excretion at Weeks 24 and 52/Withdrawal (WD)
Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD)
- +3 more secondary outcomes
Study Arms (2)
Fluticasone Furoate/GW642444 100/25mcg
EXPERIMENTALCombination inhaled corticosteroid and long-acting beta2-agonist
Fluticasone Furoate/GW642444 200/25mcg
EXPERIMENTALCombination inhaled corticosteroid and long-acting beta2-agonist
Interventions
Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
Eligibility Criteria
You may qualify if:
- Out patient at least 40 years of age
- Both genders; females childbearing potencial must be willing to use birth control method
- A diagnosis of COPD at Screening
- Subjects with a current or prior history of at least 10 pack-years of cigarett smoking at Screening
- Post-bronchodilator FEV1/FVC ratio of less than 70%
- Post-bronchodilator FEV1 of less than 80%
You may not qualify if:
- Current diagnosis of sthma
- Respiratory disorders other than COPD
- Upper or lower respiratory infection, or exacerbation of COPD within 4 weeka prior to Screening
- Concurrent other disease that would confound study participation or affect subject safety
- Allergies to study drugs, study drugs' excipients, medications related to study drugs
- Taking another investigational medication or medication prohibited for use during this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (35)
GSK Investigational Site
Fukuoka, 811-2201, Japan
GSK Investigational Site
Fukuoka, 819-8555, Japan
GSK Investigational Site
Fukushima, 964-0871, Japan
GSK Investigational Site
Gunma, 371-0048, Japan
GSK Investigational Site
Hiroshima, 732-0057, Japan
GSK Investigational Site
Hokkaido, 001-0901, Japan
GSK Investigational Site
Hokkaido, 064-0915, Japan
GSK Investigational Site
Hokkaido, 070-8644, Japan
GSK Investigational Site
Hyōgo, 651-0073, Japan
GSK Investigational Site
Ibaraki, 300-0053, Japan
GSK Investigational Site
Ibaraki, 310-0015, Japan
GSK Investigational Site
Ishikawa, 920-8610, Japan
GSK Investigational Site
Kagawa, 760-0073, Japan
GSK Investigational Site
Kagawa, 763-8502, Japan
GSK Investigational Site
Kanagawa, 239-0821, Japan
GSK Investigational Site
Kyoto, 601-1495, Japan
GSK Investigational Site
Kyoto, 615-8087, Japan
GSK Investigational Site
Miyagi, 981-8563, Japan
GSK Investigational Site
Miyagi, 984-8560, Japan
GSK Investigational Site
Nagano, 390-0303, Japan
GSK Investigational Site
Nagano, 390-0832, Japan
GSK Investigational Site
Nagano, 390-8601, Japan
GSK Investigational Site
Nagano, 391-0011, Japan
GSK Investigational Site
Okayama, 701-0304, Japan
GSK Investigational Site
Osaka, 530-0012, Japan
GSK Investigational Site
Osaka, 545-8586, Japan
GSK Investigational Site
Osaka, 576-0016, Japan
GSK Investigational Site
Osaka, 589-0022, Japan
GSK Investigational Site
Ōita, 870-0921, Japan
GSK Investigational Site
Ōita, 876-0047, Japan
GSK Investigational Site
Tokyo, 185-0014, Japan
GSK Investigational Site
Tokyo, 187-0024, Japan
GSK Investigational Site
Toyama, 930-0194, Japan
GSK Investigational Site
Wakayama, 641-8510, Japan
GSK Investigational Site
Yamanashi, 400-0031, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2010
First Posted
August 31, 2010
Study Start
August 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
January 11, 2017
Results First Posted
August 12, 2013
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.