Protocol Summary for SCO30005
| Protocol Id: | SCO30005 |
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| 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 |
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| FDA Regulated Intervention?: | |
| Section 801 Clinical Trial?: | |
| Delayed Posting: | |
| IND/IDE Protocol?: | No |
| Study Type: | interventional |
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| 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 |
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| Primary Purpose: | Treatment |
| Allocation: | Randomized |
| Masking: | Double Blind |
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| Study Design (Assignment): | Parallel Assignment |
| Study Classification (Endpoint): | Efficacy Study |
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| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion 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: |
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Click to view inclusion/exclusion criteria