Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, double-blind, multi-dose, parallel group trial which will assess the pharmacodynamic response of fluticasone propionate and formoterol fumarate in subjects with COPD.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
| |
| 5 | Experimental |
| |
| 6 | Active Comparator |
| |
| 7 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Propionate/Formoterol Fumarate | Drug | Inhalation Suspension |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in forced expiratory volume at one second (FEV1) measured in milliliters by spirometry to assess pharmacodynamic response of fluticasone propionate in combination with formoterol fumarate in subject with COPD | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | 12 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Phoenix | Arizona | United States | |||
| Investigative Site |
Not provided
Not provided
Not provided
Not provided
Not provided
| Fluticasone Propionate/Formoterol Fumarate |
| Drug |
Inhalation Suspension |
|
| Fluticasone Propionate/Formoterol Fumarate | Drug | Inhalation Suspension |
|
| Fluticasone Propionate/Formoterol Fumarate | Drug | Inhalation Suspension |
|
| Fluticasone Propionate/Formoterol Fumarate | Drug | Inhalation Suspension |
|
| Formoterol Fumarate | Drug | Inhalation Solution |
|
| Placebo | Drug | Inhalation Solution |
|
| Fullerton |
| California |
| United States |
| Investigative Site | San Diego | California | United States |
| Investigative Site | Clearwater | Florida | United States |
| Investigative Site | DeLand | Florida | United States |
| Investigative Site | Tamarac | Florida | United States |
| Investigative Site | Lawrenceville | Georgia | United States |
| Investigative Site | Coeur d'Alene | Idaho | United States |
| Investigative Site | Madisonville | Kentucky | United States |
| Investigative Site | Sunset | Louisiana | United States |
| Investigative Site | St Louis | Missouri | United States |
| Investigative Site | Charlotte | North Carolina | United States |
| Investigative Site | Raleigh | North Carolina | United States |
| Investigative site | Sylvania | Ohio | United States |
| Investigative Site | Medford | Oregon | United States |
| Investigative Site | Easley | South Carolina | United States |
| Investigative Site | Gaffney | South Carolina | United States |
| Investigative Site | Greenville | South Carolina | United States |
| Investigative Site | Greer | South Carolina | United States |
| Investigative Site | Spartanburg | South Carolina | United States |
| Invesigative Site | Union | South Carolina | United States |
| Investigative Site | San Antonio | Texas | United States |
| Investigative Site | Spokane | Washington | United States |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| D000068759 | Formoterol Fumarate |
| 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 |
Not provided
Not provided