A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01192191
First received: August 30, 2010
Last updated: March 28, 2013
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: Fluticasone Furoate/GW642444 Inhalation Powder |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Incidence of all adverse events [ Time Frame: Over the 52-week treatment period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of pneumonia [ Time Frame: Over the 52-week treatment period ] [ Designated as safety issue: No ]
- Change from baseline in laboratory data [ Time Frame: At the end of 12 weeks, 24 weeks and the 52-week treatment period ] [ Designated as safety issue: No ]
- Change from baseline in urinary cortisol excertion [ Time Frame: At the end of 24 weeks and the 52-week treatment period ] [ Designated as safety issue: No ]
- Change from baseline in vital signs [ Time Frame: Over the 52 week treatment period ] [ Designated as safety issue: No ]
- Frequency of abnormal findings of 12-lead ECG [ Time Frame: At the end of 12 weeks, 24 weeks and the 52-week treatment period ] [ Designated as safety issue: No ]
| Enrollment: | 187 |
| Study Start Date: | August 2010 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fluticasone Furoate/GW642444
Combination inhaled corticosteroid and long-acting beta2-agonist
|
Drug: Fluticasone Furoate/GW642444 Inhalation Powder
Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192191
Locations
| Japan | |
| GSK Investigational Site | |
| Fukuoka, Japan, 811-2201 | |
| GSK Investigational Site | |
| Fukuoka, Japan, 819-8555 | |
| GSK Investigational Site | |
| Fukushima, Japan, 964-0871 | |
| GSK Investigational Site | |
| Gunma, Japan, 371-0048 | |
| GSK Investigational Site | |
| Hiroshima, Japan, 732-0057 | |
| GSK Investigational Site | |
| Hokkaido, Japan, 001-0901 | |
| GSK Investigational Site | |
| Hokkaido, Japan, 064-0915 | |
| GSK Investigational Site | |
| Hokkaido, Japan, 070-8644 | |
| GSK Investigational Site | |
| Hyogo, Japan, 651-0073 | |
| GSK Investigational Site | |
| Ibaraki, Japan, 310-0015 | |
| GSK Investigational Site | |
| Ibaraki, Japan, 300-0053 | |
| GSK Investigational Site | |
| Ishikawa, Japan, 920-8610 | |
| GSK Investigational Site | |
| Kagawa, Japan, 763-8502 | |
| GSK Investigational Site | |
| Kagawa, Japan, 760-0073 | |
| GSK Investigational Site | |
| Kanagawa, Japan, 239-0821 | |
| GSK Investigational Site | |
| Kyoto, Japan, 615-8087 | |
| GSK Investigational Site | |
| Kyoto, Japan, 601-1495 | |
| GSK Investigational Site | |
| Miyagi, Japan, 984-8560 | |
| GSK Investigational Site | |
| Miyagi, Japan, 981-8563 | |
| GSK Investigational Site | |
| Nagano, Japan, 391-0011 | |
| GSK Investigational Site | |
| Nagano, Japan, 390-0303 | |
| GSK Investigational Site | |
| Nagano, Japan, 390-8601 | |
| GSK Investigational Site | |
| Nagano, Japan, 390-0832 | |
| GSK Investigational Site | |
| Oita, Japan, 876-0047 | |
| GSK Investigational Site | |
| Oita, Japan, 870-0921 | |
| GSK Investigational Site | |
| Okayama, Japan, 701-0304 | |
| GSK Investigational Site | |
| Osaka, Japan, 530-0012 | |
| GSK Investigational Site | |
| Osaka, Japan, 545-8586 | |
| GSK Investigational Site | |
| Osaka, Japan, 589-0022 | |
| GSK Investigational Site | |
| Osaka, Japan, 576-0016 | |
| GSK Investigational Site | |
| Tokyo, Japan, 185-0014 | |
| GSK Investigational Site | |
| Tokyo, Japan, 187-0024 | |
| GSK Investigational Site | |
| Toyama, Japan, 930-0194 | |
| GSK Investigational Site | |
| Wakayama, Japan, 641-8510 | |
| GSK Investigational Site | |
| Yamanashi, Japan, 400-0031 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01192191 History of Changes |
| Other Study ID Numbers: | 114156 |
| Study First Received: | August 30, 2010 |
| Last Updated: | March 28, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by GlaxoSmithKline:
|
GW642444 COPD Fluticasone Furoate |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract 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 23, 2013