A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD.
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive
Intervention: Fluticasone Furoate/GW642444 Inhalation Powder (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
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.
Clinical Details
Official title: 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)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Incidence of all adverse events
Secondary outcome: Incidence of pneumoniaChange from baseline in laboratory data Change from baseline in urinary cortisol excertion Change from baseline in vital signs Frequency of abnormal findings of 12-lead ECG
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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%
Exclusion Criteria:
- 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
Locations and Contacts
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: info@clinicaltrialsforgsk.com
GSK Investigational Site, Fukuoka 819-8555, Japan
GSK Investigational Site, Gifu 500-8523, Japan
GSK Investigational Site, Hokkaido 001-0901, Japan
GSK Investigational Site, Hokkaido 070-0901, Japan
GSK Investigational Site, Hokkaido 064-0915, Japan
GSK Investigational Site, Hyogo 651-0073, Japan
GSK Investigational Site, Ibaraki 310-0015, Japan
GSK Investigational Site, Ishikawa 920-8610, Japan
GSK Investigational Site, Kyoto 601-1495, Japan
GSK Investigational Site, Kyoto 615-8087, Japan
GSK Investigational Site, Miyagi 984-8560, Japan
GSK Investigational Site, Miyagi 981-8563, Japan
GSK Investigational Site, Nagano 391-0011, Japan
GSK Investigational Site, Nagano 390-0832, Japan
GSK Investigational Site, Nagano 390-8601, Japan
GSK Investigational Site, Nagano 390-0303, Japan
GSK Investigational Site, Oita 870-0921, Japan
GSK Investigational Site, Okayama 701-0304, Japan
GSK Investigational Site, Osaka 530-0012, Japan
GSK Investigational Site, Osaka 589-0022, Japan
GSK Investigational Site, Osaka 545-8586, Japan
GSK Investigational Site, Wakayama 641-8510, Japan
GSK Investigational Site, Yamanashi 400-0031, Japan
Additional Information
Starting date: August 2010
Last updated: August 30, 2010
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