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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salmeterol/fluticasone propionate 50/500mcg Diskus | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aalborg | DK-9100 | Denmark | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Barnes NC, Qiu Y, Zhu J, et al. Anti-inflammatory effects of salmeterol/fluticasone propionate (SFC) by smoking status in COPD. Eur Respir J 2005; 26(suppl 49): 204S. | ||
| Background | Barnes NC, Qiu YS, Pavord I. Clinical improvement with salmeterol/fluticasone proprionate is associated with reduction in inflammation in patients with COPD. European Respiratory Journal Supplement 2005; 26(Suppl. 49): 717 (plus poster) Abstract P4574. | ||
| 16424444 | Background | Barnes NC, Qiu YS, Pavord ID, Parker D, Davis PA, Zhu J, Johnson M, Thomson NC, Jeffery PK; SCO30005 Study Group. Antiinflammatory effects of salmeterol/fluticasone propionate in chronic obstructive lung disease. Am J Respir Crit Care Med. 2006 Apr 1;173(7):736-43. doi: 10.1164/rccm.200508-1321OC. Epub 2006 Jan 19. | |
| Background |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| SCO30005 | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| København NV |
| 2400 |
| Denmark |
| GSK Investigational Site | Tallinn | 13419 | Estonia |
| GSK Investigational Site | Tartu | 51014 | Estonia |
| GSK Investigational Site | Helsinki | 00029 | Finland |
| GSK Investigational Site | Palermo | Sicily | 90146 | Italy |
| GSK Investigational Site | Kaunas | LT-44320 | Lithuania |
| GSK Investigational Site | Kaunas | LT-50009 | Lithuania |
| GSK Investigational Site | Vilnius | LT-08661 | Lithuania |
| GSK Investigational Site | Bratislava | 825 56 | Slovakia |
| GSK Investigational Site | Košice | 041 90 | Slovakia |
| GSK Investigational Site | Cáceres | 10003 | Spain |
| GSK Investigational Site | Madrid | 28047 | Spain |
| GSK Investigational Site | Leicester | Leicestershire | LE3 9QP | United Kingdom |
| GSK Investigational Site | Norwich | Norfolk | NR4 7UZ | United Kingdom |
| GSK Investigational Site | Nottingham | Nottinghamshire | NG5 1PB | United Kingdom |
| GSK Investigational Site | Nottingham | Nottinghamshire | NG7 2UH | United Kingdom |
| GSK Investigational Site | Hull | HU16 5JQ | United Kingdom |
| GSK Investigational Site | London | E2 9JX | United Kingdom |
| GSK Investigational Site | London | E7 8QP | United Kingdom |
| Baseline characteristics of the first 5,000 copd patients enrolled in the torch survival study. Calverley, P. M. A., Celli, B., Ferguson, G., Jenkins, C., Jones, P., Pride, N. B., Vestbo, J., Anderson, J., and Pauwels, R. 13th Annual Congress of the European Respiratory Society 9/27/2003 Vienna; Austria |
| Background | Pavord I, Parker D, Barnes NC, et al. Effects of salmeterol/fluticasone propionate (SFC) on airway inflammation in induced sputum in COPD. Eur Respir J 2005; 26(suppl 49): 203S. |
| Background | Qiu Y, Davis P, Zhu J, et al. Anti-inflammatory effects of salmeterol/fluticasone propionate (SFC) on airway T-lymphocyte populations in COPD. Eur Respir J 2005; 26(suppl 49): 203S. |
| Background | Qiu Y, Davis P, Zhu J, et al. Effects of salmeterol/fluticasone propionate (SFC) on airway inflammation in COPD: a placebo-controlled study of endobronchial biopsies. Eur Respir J 2005; 26(suppl 49): 203S. |
| 15332386 | Background | Vestbo J; TORCH Study Group. The TORCH (towards a revolution in COPD health) survival study protocol. Eur Respir J. 2004 Aug;24(2):206-10. doi: 10.1183/09031936.04.00120603. |
| Background | Zhu J, Qiu Y, Barnes NC, Johnson M, Pavord I, Jeffery P. The effect of salmeterol/fluticasone propionate (SFC) on pro-inflammatory gene expression in COPD. PATS 2005; 2(abstracts issue): A127 |
For additional information about this study please refer to the GSK Clinical Study Register |
| SCO30005 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCO30005 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCO30005 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCO30005 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCO30005 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCO30005 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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