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Airway Inflammation In Patients With Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00268177
First Posted: December 22, 2005
Last Update Posted: September 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
December 20, 2005
December 22, 2005
September 15, 2016
October 2002
Not Provided
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
Same as current
Complete list of historical versions of study NCT00268177 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Airway Inflammation In Patients With Chronic Obstructive Pulmonary Disease
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)
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
Drug: Salmeterol/fluticasone propionate 50/500mcg Diskus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
December 2003
Not Provided

Inclusion Criteria:

  • Established clinical history of chronic obstructive airways disease.
  • Must be current or ex-smokers with a smoking history of at least 10 pack-years (e.g. 20 cigarettes/day for 10 years or 10 cigarettes/day for 20 years).
  • Must have reduced lung function, defined as a Forced Expiratory Volume in 1 second (FEV1) of between 40-80% of predicted normal values.

Exclusion Criteria:

  • Diagnosis of any other serious disease and must have a chest X-ray to eliminate a diagnosis other than COPD.
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Estonia,   Finland,   Italy,   Lithuania,   Slovakia,   Spain,   United Kingdom
 
 
NCT00268177
SCO30005
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP