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Relatively little information is available about the effects of salmeterol/fluticasone combination and fluticasone alone in COPD patients with a partial reversible pulmonary obstruction. The purpose of this study is to compare the effects of salmeterol/fluticasone combination with fluticasone alone delivered via Diskus/ACCUHALER inhaler in subjects with COPD on lung function over a 1 year period.
Multi-centre, double-blind, randomised and stratified parallel group study to compare the efficacy and safety of fluticasone propionate 500 mcg bd versus salmeterol/fluticasone combination 50/250 mcg bd both via Diskus inhaler during 1 year in Chronic Obstructive Pulmonary Disease(COPD) patients with a partially reversible obstruction.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone propionate/salmeterol 250/50 DISKUS combination product | Drug | |||
| fluticasone propionate DISKUS 500mcg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in efficacy of a 12 months treatment with salmeterol/fluticasone combination versus fluticasone on lung function (FEV1) as percentage predicted. |
| Measure | Description | Time Frame |
|---|---|---|
| Reversibility of lung function with salbutamol and on Forced Vital capacity (FVC), TLC, FRC, FVC, Inspiration capacity(IC), Forced Inspiratory Volume in 1 second (FIV1) and Maximum mid-Expiratory Flow (MEF50). |
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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 | Alkmaar | 1815 JD | Netherlands | |||
| GSK Investigational Site |
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| Almelo |
| 7609 PP |
| Netherlands |
| GSK Investigational Site | Amsterdam | 1034 CS | Netherlands |
| GSK Investigational Site | Amsterdam | 1058 NR | Netherlands |
| GSK Investigational Site | Amsterdam | 1091 AC | Netherlands |
| GSK Investigational Site | Drachten | 9202 NN | Netherlands |
| GSK Investigational Site | Haarlem | 2012 CE | Netherlands |
| GSK Investigational Site | Harderwijk | 3844 DG | Netherlands |
| GSK Investigational Site | Hengelo | 7555 DL | Netherlands |
| GSK Investigational Site | Hoorn | 1624 NP | Netherlands |
| GSK Investigational Site | Leeuwarden | 8934 AD | Netherlands |
| GSK Investigational Site | Meppel | 7943 KA | Netherlands |
| GSK Investigational Site | Nijmegen | 6532 SZ | Netherlands |
| GSK Investigational Site | Rotterdam | 3045 PM | Netherlands |
| GSK Investigational Site | Sneek | 8601 ZK | Netherlands |
| GSK Investigational Site | Utrecht | 2584 CX | Netherlands |
| GSK Investigational Site | Voerendaal | 6367 ED | Netherlands |
| 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 |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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