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Protocol Summary for 113107

Protocol Summary
Protocol Id: 113107
Secondary Ids:
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
Oversight Authority:
  • Europe: European Medicines Agency
  • United States: Food and Drug Administration
Collaborators:
  • N/A
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:
  • Change from baseline trough in 24-hour weighted-mean serial FEV1 Treatment Day 84 (Visit 5)
Secondary Outcomes:
  • Trough FEV1 Treatment Day 85 (Visit 5)
  • Time to onset increase in 100mL above baseline in FEV1 on Treatment Day 1 (Visit 2)
Conditions:
  • Pulmonary Disease, Chronic Obstructive
Keywords:
Eligibility Criteria: Click to view inclusion/exclusion 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:
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