Protocol Summary for 113107
| Protocol Id: | 113107 |
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| Title: | A 12-week study to evaluate the 24 hour pulmonary function of Fluticasone Furoate (FF)/Vilanterol Inhalation Powder (FF/VI Inhalation Powder) once daily compared with Salmeterol/Fluticasone Propionate (FP) Inhalation Powder twice daily in subjects with Chronic Obstructive Pulmonary Disease (COPD) |
| Phase: | phase 3 |
| Acronym: | |
| FDA Regulated Intervention?: | Yes |
| Section 801 Clinical Trial?: | Yes |
| Delayed Posting: | No |
| IND/IDE Protocol?: | yes |
| IND/IDE Grantor: | CBER |
| IND/IDE Number: | 077855 050703 |
| IND/IDE Serial Number: | |
| Has Expanded Access?: | no |
| Study Type: | Interventional |
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| Brief Summary: | The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol 100/25mcg once daily compared with Salmeterol/Fluticasone Propionate 50/500mcg twice daily over a 12-week treatmen period in subjects with COPD. |
| Detailed Description: | This is a randomized, double-blind, double-dummy, multi-centre parallel group study. Subjects who meet the eligilibilty criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week Treatment period. There will be a 7-day Follow-up period after the treatment period. |
| Record Verification Date: | April 2012 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | February 2011 |
| Study Completion Date: | October 2011 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | October 2011 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | treatment |
| Allocation: | Randomized |
| Masking: | Double Blind |
| Masked Subject: | yes |
| Masked Caregiver: | no |
| Masked Investigator: | yes |
| Masked Assessor: | no |
| Study Design (Assignment): | Parallel Assignment |
| Study Classification (Endpoint): | Safety/Efficacy Study |
| Primary Outcomes: |
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| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 40 Year |
| Maximum Age: | |
| Enrollment: | 531 |
| 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: | |
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| 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: |
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Click to view inclusion/exclusion criteria