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This study will last for approximately 14 weeks and will involve 5 visits. The study is being carried out to look at different ways of measuring the effect of drug treatment on COPD. COPD is a respiratory disease which can affect your breathing and daily life. Symptoms of COPD can include breathlessness, cough, and wheeze. COPD varies enormously from patient to patient. The effects of drug treatment are usually measured by conducting lung function tests (breathing tests) using a machine called a spirometer but this does not always provide a complete picture of how well your COPD is responding. In this study we therefore want to look at new and more sensitive ways of measuring COPD. The results of this research will help in the assessment of new drugs for COPD in the future.
Evaluation of Novel Endpoints in Subjects with Chronic Obstructive Pulmonary Disease (COPD) in a Randomized, Double-Blind, Placebo-Controlled Study of Treatment with Fluticasone Propionate/Salmeterol 500/50mcg combination (FSC 500/50) and its individual components, Fluticasone Propionate 500mcg (FP500) and Salmeterol 50mcg (SAL 50)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Propionate/Salmeterol 500/50mcg combination | Drug | |||
| Fluticasone Propionate 500mcg | Drug | |||
| Salmeterol 50mcg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral airway resistance measured by IOS |
| Measure | Description | Time Frame |
|---|---|---|
| Airway wall thickness measured by CT scans |
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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 | Absecon | New Jersey | 8201 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27651909 | Derived | Kreindler JL, Watkins ML, Lettis S, Tal-Singer R, Locantore N. Effect of inhaled corticosteroids on blood eosinophil count in steroid-naive patients with COPD. BMJ Open Respir Res. 2016 Sep 8;3(1):e000151. doi: 10.1136/bmjresp-2016-000151. eCollection 2016. |
| 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 |
|---|---|---|---|
| SCO104925 | Clinical Study Report | 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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| Charleston |
| South Carolina |
| 29406-7108 |
| United States |
| GSK Investigational Site | Greenville | South Carolina | 29615 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 7500691 | Chile |
| GSK Investigational Site | Valparaíso | Valparaiso | 2341131 | Chile |
| GSK Investigational Site | Tartu | 51014 | Estonia |
| GSK Investigational Site | Barnaul | 656 045 | Russia |
| GSK Investigational Site | Moscow | 105 077 | Russia |
| GSK Investigational Site | Moscow | 105 229 | Russia |
| GSK Investigational Site | Nizhnekamsk | 423570 | Russia |
For additional information about this study please refer to the GSK Clinical Study Register |
| SCO104925 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCO104925 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCO104925 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCO104925 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCO104925 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCO104925 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| 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 |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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