Quick Search

 

 


 

 

Protocol Summary for SCO30005

Protocol Summary
Protocol Id: SCO30005
Secondary Ids:
Title: A 13-week, double-blind, parallel group, multi-centre study to compare the bronchial anti-inflammatory activity of the combination of salmeterol/fluticasone propionate 50/500mcg twice daily compared with placebo twice daily in patients with Chronic Obstructive Pulmonary Disease (COPD)
Phase: Phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: No
Study Type: interventional
Oversight Authority:
  • United Kingdom: Medicines and Healthcare Products Regulatory Agency
  • Denmark: Danish Medicines Agency
  • Estonia: The State Agency of Medicine
  • Finland: National Agency for Medicines
  • Italy: The Italian Medicines Agency
  • Lithuania: State Medicine Control Agency - Ministry of Health
  • Slovakia: State Institute for Drug Control
  • Spain: Spanish Agency of Medicines
Collaborators:
Brief Summary: This study was designed to look at effects of salmeterol/fluticasone propionate compared to placebo on airway inflammation in patients with chronic obstructive airways disease
Detailed Description:
Record Verification Date: April 2010
Status: Completed
Why Study Stopped:
Study Start Date: October 2002
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose: Treatment
Allocation: Randomized
Masking: Double Blind
Masked Subject:
Masked Caregiver:
Masked Investigator:
Masked Assessor:
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Efficacy Study
Primary Outcomes:
  • To compare the number of CD68+ and CD8+ inflammatory cells per area of biopsy tissue and the percentage and total number of neutrophils in induced sputum between salmeterol/fluticasone propionate and placebo
Secondary Outcomes:
  • To compare the number of mast cells, CD45+,CD4+,IFN-gamma mRNA+,TNF-alpha mRNA+, per area of biopsy and the percentage and number of macrophages, eosinophils, lymphocytes in induced sputum between salmeterol/fluticasone propionate and placebo
Conditions:
  • Pulmonary Disease, Chronic Obstructive
Keywords:
  • Chronic
  • Obstructive
  • Pulmonary
  • Airways
  • salmeterol/fluticasone propionate
  • inflammation
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 40 Years
Maximum Age: 80 Years
Enrollment: 130
Enrollment Type:
Healthy Volunteers?: no
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
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