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The purpose of the study is to determine the appropriate dose of fluticasone propionate/formoterol fumarate that is closest to Advair Diskus (fluticasone propionate/salmeterol xinafoate using pulmonary function, safety, and levels of study drug in blood plasma in patients with chronic obstructive pulmonary disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C 10/1 | Experimental |
| |
| C 5/2 | Experimental |
| |
| C 5/1 | Experimental |
| |
| FP 1000 | Experimental |
| |
| FF 20 | Experimental |
| |
| AD 250/50 | Active Comparator |
| |
| Plc | Placebo Comparator |
| |
| C 10/2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Propionate/Formoterol Fumarate | Drug | Inhalation suspension for nebulization 1000/20 mcg bid for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-hour post-dose FEV1 | 2 weeks | |
| AUC(0-12) and Cmax in plasma | 2 weeks | |
| pre-dose FEV1 | 2 weeks | |
| Amount and percent total dose excreted in urine | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 AUC(0-2) | 2 weeks | |
| COPD exacerbations | ||
| Treatment Emergent Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35209 | United States | ||
| Research Site |
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|
| Fluticasone Propionate/Formoterol Fumarate | Drug | Inhalation Suspension for nebulization 1000/10 mcg bid for 2 weeks |
|
| Fluticasone Propionate/Formoterol Fumarate | Drug | Inhalation Suspension for nebulization 500/20 mcg bid for 2 weeks |
|
| Fluticasone Propionate/Formoterol Fumarate | Drug | Inhalation Suspension for nebulization 500/10 mcg bid for 2 weeks |
|
| Fluticasone Propionate | Drug | Inhalation Suspension for nebulization 1000 mcg bid for 2 weeks |
|
| Formoterol Fumarate | Drug | Inhalation Solution for nebulization 20 mcg bid for 2 weeks |
|
| Fluticasone Propionate/Salmeterol Xinafoate | Drug | Inhalation Powder delivered by Diskus device 250/50 mcg bid for 2 weeks |
|
| Placebo | Drug | Inhalation Solution for nebulization 2 mL bid for 2 weeks |
|
| 2 weeks |
| Jasper |
| Alabama |
| 35501 |
| United States |
| Research Site | Phoenix | Arizona | 85006 | United States |
| Research Site | Buena Park | California | 90620 | United States |
| Research Site | Costa Mesa | California | 92626 | United States |
| Research Site | Encinitas | California | 92024 | United States |
| Research Site | Los Angeles | California | 90095 | United States |
| Research Site | San Diego | California | 92120 | United States |
| Research Site | Wheat Ridge | Colorado | 80033 | United States |
| Research Site | Clearwater | Florida | 33765 | United States |
| Research Site | DeLand | Florida | 32720 | United States |
| Research Site | Tamarac | Florida | 33321 | United States |
| Research Site | Tampa | Florida | 33603 | United States |
| Research Site | Atlanta | Georgia | 30309 | United States |
| Research Site | Woodstock | Georgia | 30189 | United States |
| Research Site | Coeur d'Alene | Idaho | 83814 | United States |
| Research Site | Hines | Illinois | 60141 | United States |
| Research Site | Lenexa | Kansas | 66219 | United States |
| Research Site | Topeka | Kansas | 66606 | United States |
| Research Site | Madisonville | Kentucky | 42431 | United States |
| Research Site | Wheaton | Maryland | 20902 | United States |
| Research Site | Minneapolis | Minnesota | 55402 | United States |
| Research Site | Saint Charles | Missouri | 63301 | United States |
| Research Site | St Louis | Missouri | 63122 | United States |
| Research Site | Henderson | Nevada | 89014 | United States |
| Research Site | Cherry Hill | New Jersey | 08003 | United States |
| Research Site | Albuquerque | New Mexico | 87108 | United States |
| Research Site | Camillus | New York | 13031 | United States |
| Research Site | Liverpool | New York | 13088 | United States |
| Research Site | Charlotte | North Carolina | 28207 | United States |
| Research Site | Greenville | North Carolina | 29615 | United States |
| Research Site | Morrisville | North Carolina | 27560 | United States |
| Research Site | Raleigh | North Carolina | 27607 | United States |
| Research Site | Cincinnati | Ohio | 45227 | United States |
| Research Site | Cincinnati | Ohio | 45231 | United States |
| Research Site | Cincinnati | Ohio | 45242 | United States |
| Research Site | Oklahoma City | Oklahoma | 73104 | United States |
| Research Site | Medford | Oregon | 97504 | United States |
| Research Site | Portland | Oregon | 97213 | United States |
| Research Site | East Providence | Rhode Island | 02914 | United States |
| Research Site | Spartanburg | South Carolina | 29303 | United States |
| Research Site | Austin | Texas | 78750 | United States |
| Research Site | Dallas | Texas | 75231 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | South Burlington | Vermont | 05403 | United States |
| Research Site | Abingdon | Virginia | 24210 | United States |
| Research Site | Richmond | Virginia | 23225 | United States |
| Research Site | Tacoma | Washington | 98405 | United States |
| Research Site | Milwaukee | Wisconsin | 53217 | United States |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D004194 | Disease |
| 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 |
|---|---|
| D000068298 | Fluticasone |
| D000068759 | Formoterol Fumarate |
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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